Scolaris Content Display Scolaris Content Display

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
 'Other bias' includes potentially active placebos.
Figuras y tablas -
Figure 1

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
'Other bias' includes potentially active placebos.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
 'Other bias' includes potentially active placebos.
Figuras y tablas -
Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
'Other bias' includes potentially active placebos.

Flow diagram describing the number of studies identified, inclusion, exclusion and progression from identification to stage 1 to stage 2 of the review.NB Because of the absence of trial programmes for both drugs listing all sponsored trials completed or underway, we had to rely on a variety of sources for the reconstruction of the trial programmes and retrieval of relevant clinical study reports. This complexity is reflected in the flowchart, illustrating the study selection process for this review. The two main pathways were the spontaneous release of 77 clinical full clinical study reports by Roche and the requests to regulatory authorities and GSK for all the relevant reports. There was overlap in trial reports retrieved following the different pathways
Figuras y tablas -
Figure 3

Flow diagram describing the number of studies identified, inclusion, exclusion and progression from identification to stage 1 to stage 2 of the review.

NB Because of the absence of trial programmes for both drugs listing all sponsored trials completed or underway, we had to rely on a variety of sources for the reconstruction of the trial programmes and retrieval of relevant clinical study reports. This complexity is reflected in the flowchart, illustrating the study selection process for this review. The two main pathways were the spontaneous release of 77 clinical full clinical study reports by Roche and the requests to regulatory authorities and GSK for all the relevant reports. There was overlap in trial reports retrieved following the different pathways

Forest plot of comparison: 1 Oseltamivir versus placebo for treatment, outcome: 1.1 Time to first alleviation of symptoms in adult treatment (ITT population) [hours].
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Oseltamivir versus placebo for treatment, outcome: 1.1 Time to first alleviation of symptoms in adult treatment (ITT population) [hours].

Forest plot of comparison: 3 Zanamivir versus placebo for treatment, outcome: 3.1 Time to first alleviation of symptoms in adult treatment (days).
Figuras y tablas -
Figure 5

Forest plot of comparison: 3 Zanamivir versus placebo for treatment, outcome: 3.1 Time to first alleviation of symptoms in adult treatment (days).

Forest plot of comparison: 3 Zanamivir versus placebo for treatment, outcome: 3.68 Time to first alleviation of symptoms in adults with/without relief medication [days].
Figuras y tablas -
Figure 6

Forest plot of comparison: 3 Zanamivir versus placebo for treatment, outcome: 3.68 Time to first alleviation of symptoms in adults with/without relief medication [days].

Forest plot of comparison: 1 Oseltamivir versus placebo for treatment, outcome: 1.17 Complications: pneumonia in adult treatment.
Figuras y tablas -
Figure 7

Forest plot of comparison: 1 Oseltamivir versus placebo for treatment, outcome: 1.17 Complications: pneumonia in adult treatment.

Example Diary card from case‐report form for Zanamivir trial
Figuras y tablas -
Figure 8

Example Diary card from case‐report form for Zanamivir trial

Example Diary card from case‐report form for Zanamivir trial (cont)
Figuras y tablas -
Figure 9

Example Diary card from case‐report form for Zanamivir trial (cont)

Forest plot of comparison: 2 Oseltamivir versus placebo for prophylaxis, outcome: 2.19 Adverse events: headache in adult prophylaxis (on‐treatment).
Figuras y tablas -
Figure 10

Forest plot of comparison: 2 Oseltamivir versus placebo for prophylaxis, outcome: 2.19 Adverse events: headache in adult prophylaxis (on‐treatment).

Forest plot of comparison: 2 Oseltamivir versus placebo for prophylaxis, outcome: 2.54 Adverse events: psychiatric body system in adult prophylaxis (on‐ and off‐treatment).
Figuras y tablas -
Figure 11

Forest plot of comparison: 2 Oseltamivir versus placebo for prophylaxis, outcome: 2.54 Adverse events: psychiatric body system in adult prophylaxis (on‐ and off‐treatment).

Sample "Adverse event or intercurrent illness" form (oseltamivir study M76001)
Figuras y tablas -
Figure 12

Sample "Adverse event or intercurrent illness" form (oseltamivir study M76001)

Sample "Secondary illness" form (oseltamivir study WV15670)
Figuras y tablas -
Figure 13

Sample "Secondary illness" form (oseltamivir study WV15670)

Sample "Diagnosis of secondary illness" form, page 1/2 (oseltamivir study WV15978)
Figuras y tablas -
Figure 14

Sample "Diagnosis of secondary illness" form, page 1/2 (oseltamivir study WV15978)

Sample "Diagnosis of secondary illness" form, page 2/2 (oseltamivir study WV15978)
Figuras y tablas -
Figure 15

Sample "Diagnosis of secondary illness" form, page 2/2 (oseltamivir study WV15978)

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 1 Time to first alleviation of symptoms in adult treatment (ITT population).
Figuras y tablas -
Analysis 1.1

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 1 Time to first alleviation of symptoms in adult treatment (ITT population).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 2 Hospital admission in adult treatment (safety population).
Figuras y tablas -
Analysis 1.2

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 2 Hospital admission in adult treatment (safety population).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 3 Defined as influenza‐infected at baseline in adult treatment.
Figuras y tablas -
Analysis 1.3

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 3 Defined as influenza‐infected at baseline in adult treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 4 Antibody rise four‐fold or greater in adult treatment.
Figuras y tablas -
Analysis 1.4

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 4 Antibody rise four‐fold or greater in adult treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 5 Adverse events ‐ nausea in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.5

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 5 Adverse events ‐ nausea in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 6 Adverse events ‐ vomiting in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.6

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 6 Adverse events ‐ vomiting in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 7 Adverse events ‐ diarrhoea in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.7

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 7 Adverse events ‐ diarrhoea in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 8 Withdrawal from adult treatment trial due to adverse events.
Figuras y tablas -
Analysis 1.8

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 8 Withdrawal from adult treatment trial due to adverse events.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 9 All withdrawals from adult treatment.
Figuras y tablas -
Analysis 1.9

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 9 All withdrawals from adult treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 10 Adverse events ‐ cough in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.10

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 10 Adverse events ‐ cough in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 11 Adverse events ‐ abdominal pain in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.11

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 11 Adverse events ‐ abdominal pain in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 12 Adverse events: dizziness in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.12

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 12 Adverse events: dizziness in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 13 Adverse events: headache in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.13

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 13 Adverse events: headache in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 14 Serious adverse events: overall in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.14

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 14 Serious adverse events: overall in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 15 Serious adverse events: overall in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.15

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 15 Serious adverse events: overall in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 16 Complications: bronchitis in adult treatment.
Figuras y tablas -
Analysis 1.16

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 16 Complications: bronchitis in adult treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 17 Complications: pneumonia in adult treatment.
Figuras y tablas -
Analysis 1.17

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 17 Complications: pneumonia in adult treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 18 Complications: sinusitis in adult treatment.
Figuras y tablas -
Analysis 1.18

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 18 Complications: sinusitis in adult treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 19 Complications: otitis media in adult treatment.
Figuras y tablas -
Analysis 1.19

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 19 Complications: otitis media in adult treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 20 Complications in adult trials classified as serious or leading to study withdrawal.
Figuras y tablas -
Analysis 1.20

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 20 Complications in adult trials classified as serious or leading to study withdrawal.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 21 Culture‐positive at baseline in adult treatment.
Figuras y tablas -
Analysis 1.21

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 21 Culture‐positive at baseline in adult treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 22 Adverse events: general body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.22

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 22 Adverse events: general body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 23 Adverse events: neurological body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.23

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 23 Adverse events: neurological body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 24 Adverse events: respiratory body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.24

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 24 Adverse events: respiratory body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 25 Adverse events: infection body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.25

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 25 Adverse events: infection body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 26 Adverse events: gastrointestinal body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.26

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 26 Adverse events: gastrointestinal body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 27 Adverse events: cardiac body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.27

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 27 Adverse events: cardiac body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 28 Adverse events: ear body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.28

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 28 Adverse events: ear body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 29 Adverse events: eye body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.29

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 29 Adverse events: eye body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 30 Adverse events: metabolism body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.30

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 30 Adverse events: metabolism body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 31 Adverse events: musculoskeletal body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.31

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 31 Adverse events: musculoskeletal body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 32 Adverse events: psychiatric body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.32

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 32 Adverse events: psychiatric body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 33 Adverse events: skin body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 1.33

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 33 Adverse events: skin body system in adult treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 34 Adverse events: cardiac body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.34

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 34 Adverse events: cardiac body system in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 35 Adverse events: ear body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.35

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 35 Adverse events: ear body system in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 36 Adverse events: gastrointestinal body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.36

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 36 Adverse events: gastrointestinal body system in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 37 Adverse events: general body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.37

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 37 Adverse events: general body system in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 38 Adverse events: infection body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.38

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 38 Adverse events: infection body system in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 39 Adverse events: musculoskeletal body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.39

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 39 Adverse events: musculoskeletal body system in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 40 Adverse events: neurological body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.40

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 40 Adverse events: neurological body system in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 41 Adverse events: respiratory body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.41

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 41 Adverse events: respiratory body system in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 42 Adverse events: skin body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.42

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 42 Adverse events: skin body system in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 43 Adverse events: cough in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.43

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 43 Adverse events: cough in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 44 Adverse events: headache in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.44

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 44 Adverse events: headache in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 45 Adverse events: nausea in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 1.45

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 45 Adverse events: nausea in adult treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 46 Time to first alleviation of symptoms in child treatment [hours].
Figuras y tablas -
Analysis 1.46

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 46 Time to first alleviation of symptoms in child treatment [hours].

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 47 Hospital admission in child treatment (safety population).
Figuras y tablas -
Analysis 1.47

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 47 Hospital admission in child treatment (safety population).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 48 Defined as influenza‐infected at baseline in child treatment.
Figuras y tablas -
Analysis 1.48

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 48 Defined as influenza‐infected at baseline in child treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 49 Antibody rise four‐fold or greater in child treatment.
Figuras y tablas -
Analysis 1.49

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 49 Antibody rise four‐fold or greater in child treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 50 Complications: bronchitis in child treatment.
Figuras y tablas -
Analysis 1.50

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 50 Complications: bronchitis in child treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 51 Complications: otitis media in child treatment.
Figuras y tablas -
Analysis 1.51

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 51 Complications: otitis media in child treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 52 Complications: pneumonia in child treatment.
Figuras y tablas -
Analysis 1.52

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 52 Complications: pneumonia in child treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 53 Complications: sinusitis in child treatment.
Figuras y tablas -
Analysis 1.53

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 53 Complications: sinusitis in child treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 54 Complications: pneumonia in child treatment by on‐ and off‐treatment.
Figuras y tablas -
Analysis 1.54

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 54 Complications: pneumonia in child treatment by on‐ and off‐treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 55 Complications in trials of children classified as serious or leading to study withdrawal.
Figuras y tablas -
Analysis 1.55

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 55 Complications in trials of children classified as serious or leading to study withdrawal.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 56 Withdrawal from child treatment trial due to adverse events.
Figuras y tablas -
Analysis 1.56

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 56 Withdrawal from child treatment trial due to adverse events.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 57 All withdrawals from child treatment.
Figuras y tablas -
Analysis 1.57

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 57 All withdrawals from child treatment.

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 58 Serious adverse events: overall in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.58

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 58 Serious adverse events: overall in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 59 Serious adverse events: overall in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.59

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 59 Serious adverse events: overall in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 60 Adverse events: abdominal pain in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.60

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 60 Adverse events: abdominal pain in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 61 Adverse events: diarrhoea in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.61

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 61 Adverse events: diarrhoea in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 62 Adverse events: nausea in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.62

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 62 Adverse events: nausea in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 63 Adverse events: vomiting in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.63

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 63 Adverse events: vomiting in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 64 Adverse events: abdominal pain in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.64

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 64 Adverse events: abdominal pain in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 65 Adverse events: cough in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.65

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 65 Adverse events: cough in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 66 Adverse events: diarrhoea in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.66

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 66 Adverse events: diarrhoea in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 67 Adverse events: headache in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.67

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 67 Adverse events: headache in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 68 Adverse events: vomiting in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.68

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 68 Adverse events: vomiting in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 69 Adverse events: ear body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.69

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 69 Adverse events: ear body system in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 70 Adverse events: gastrointestinal body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.70

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 70 Adverse events: gastrointestinal body system in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 71 Adverse events: general body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.71

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 71 Adverse events: general body system in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 72 Adverse events: infection body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.72

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 72 Adverse events: infection body system in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 73 Adverse events: neurological body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.73

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 73 Adverse events: neurological body system in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 74 Adverse events: respiratory body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.74

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 74 Adverse events: respiratory body system in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 75 Adverse events: skin body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 1.75

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 75 Adverse events: skin body system in child treatment (on‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 76 Adverse events: ear body system in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.76

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 76 Adverse events: ear body system in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 77 Adverse events: gastrointestinal body system in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.77

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 77 Adverse events: gastrointestinal body system in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 78 Adverse events: general body system in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.78

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 78 Adverse events: general body system in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 79 Adverse events: infection body system in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.79

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 79 Adverse events: infection body system in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 80 Adverse events: neurological body system in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.80

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 80 Adverse events: neurological body system in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 81 Adverse events: respiratory body system in child treatment (off‐treatment).
Figuras y tablas -
Analysis 1.81

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 81 Adverse events: respiratory body system in child treatment (off‐treatment).

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 82 Culture‐positive at baseline in child treatment.
Figuras y tablas -
Analysis 1.82

Comparison 1 Oseltamivir versus placebo for treatment, Outcome 82 Culture‐positive at baseline in child treatment.

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 1 Symptomatic influenza in adult prophylaxis of individuals.
Figuras y tablas -
Analysis 2.1

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 1 Symptomatic influenza in adult prophylaxis of individuals.

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 2 Asymptomatic influenza in adult prophylaxis of individuals.
Figuras y tablas -
Analysis 2.2

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 2 Asymptomatic influenza in adult prophylaxis of individuals.

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 3 Symptomatic influenza in household prophylaxis.
Figuras y tablas -
Analysis 2.3

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 3 Symptomatic influenza in household prophylaxis.

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 4 Asymptomatic influenza in household prophylaxis.
Figuras y tablas -
Analysis 2.4

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 4 Asymptomatic influenza in household prophylaxis.

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 5 Influenza‐like illness reported as adverse event (on‐treatment).
Figuras y tablas -
Analysis 2.5

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 5 Influenza‐like illness reported as adverse event (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 6 Influenza‐like illness reported as adverse event (off‐treatment).
Figuras y tablas -
Analysis 2.6

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 6 Influenza‐like illness reported as adverse event (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 7 Hospitalisation in adult prophylaxis (safety population).
Figuras y tablas -
Analysis 2.7

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 7 Hospitalisation in adult prophylaxis (safety population).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 8 Complications: bronchitis in adult prophylaxis.
Figuras y tablas -
Analysis 2.8

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 8 Complications: bronchitis in adult prophylaxis.

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 9 Complications: sinusitis in adult prophylaxis.
Figuras y tablas -
Analysis 2.9

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 9 Complications: sinusitis in adult prophylaxis.

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 10 Adverse events leading to study withdrawal in adult prophylaxis.
Figuras y tablas -
Analysis 2.10

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 10 Adverse events leading to study withdrawal in adult prophylaxis.

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 11 All withdrawals in adult prophylaxis.
Figuras y tablas -
Analysis 2.11

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 11 All withdrawals in adult prophylaxis.

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 12 Serious adverse events in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.12

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 12 Serious adverse events in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 13 Serious adverse events in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.13

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 13 Serious adverse events in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 14 Adverse events: abdominal pain in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.14

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 14 Adverse events: abdominal pain in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 15 Adverse events: cough in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.15

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 15 Adverse events: cough in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 16 Adverse events: diarrhoea in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.16

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 16 Adverse events: diarrhoea in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 17 Adverse events: dizziness in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.17

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 17 Adverse events: dizziness in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 18 Adverse events: fatigue in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.18

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 18 Adverse events: fatigue in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 19 Adverse events: headache in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.19

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 19 Adverse events: headache in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 20 Adverse events: nausea in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.20

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 20 Adverse events: nausea in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 21 Adverse events: vomiting in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.21

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 21 Adverse events: vomiting in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 22 Adverse events: cough in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.22

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 22 Adverse events: cough in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 23 Adverse events: fatigue in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.23

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 23 Adverse events: fatigue in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 24 Adverse events: headache in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.24

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 24 Adverse events: headache in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 25 Adverse events: blood body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.25

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 25 Adverse events: blood body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 26 Adverse events: cardiac body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.26

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 26 Adverse events: cardiac body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 27 Adverse events: ear body system in adult prophylaxis (on treatment).
Figuras y tablas -
Analysis 2.27

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 27 Adverse events: ear body system in adult prophylaxis (on treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 28 Adverse events: eye body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.28

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 28 Adverse events: eye body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 29 Adverse events: gastrointestinal body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.29

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 29 Adverse events: gastrointestinal body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 30 Adverse events: general body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.30

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 30 Adverse events: general body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 31 Adverse events: infection body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.31

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 31 Adverse events: infection body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 32 Adverse events: immune body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.32

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 32 Adverse events: immune body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 33 Adverse events: injury body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.33

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 33 Adverse events: injury body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 34 Adverse events: metabolism body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.34

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 34 Adverse events: metabolism body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 35 Adverse events: musculoskeletal body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.35

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 35 Adverse events: musculoskeletal body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 36 Adverse events: neurological body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.36

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 36 Adverse events: neurological body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 37 Adverse events: psychiatric body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.37

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 37 Adverse events: psychiatric body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 38 Adverse events: renal body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.38

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 38 Adverse events: renal body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 39 Adverse events: reproductive body system in adult prophylaxis (on treatment).
Figuras y tablas -
Analysis 2.39

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 39 Adverse events: reproductive body system in adult prophylaxis (on treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 40 Adverse events: respiratory body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.40

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 40 Adverse events: respiratory body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 41 Adverse events: skin body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.41

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 41 Adverse events: skin body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 42 Adverse events: surgical events in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.42

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 42 Adverse events: surgical events in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 43 Adverse events: vascular body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 2.43

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 43 Adverse events: vascular body system in adult prophylaxis (on‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 44 Adverse events: cardiac body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.44

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 44 Adverse events: cardiac body system in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 45 Adverse events: gastrointestinal body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.45

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 45 Adverse events: gastrointestinal body system in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 46 Adverse events: general body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.46

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 46 Adverse events: general body system in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 47 Adverse events: infection body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.47

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 47 Adverse events: infection body system in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 48 Adverse events: injury body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.48

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 48 Adverse events: injury body system in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 49 Adverse events: musculoskeletal body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.49

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 49 Adverse events: musculoskeletal body system in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 50 Adverse events: neurological body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.50

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 50 Adverse events: neurological body system in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 51 Adverse events: reproductive body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.51

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 51 Adverse events: reproductive body system in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 52 Adverse events: respiratory body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.52

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 52 Adverse events: respiratory body system in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 53 Adverse events: skin body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 2.53

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 53 Adverse events: skin body system in adult prophylaxis (off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 54 Adverse events: psychiatric body system in adult prophylaxis (on and off‐treatment).
Figuras y tablas -
Analysis 2.54

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 54 Adverse events: psychiatric body system in adult prophylaxis (on and off‐treatment).

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 55 Adverse events: renal body system in adult prophylaxis (on and off‐treatment).
Figuras y tablas -
Analysis 2.55

Comparison 2 Oseltamivir versus placebo for prophylaxis, Outcome 55 Adverse events: renal body system in adult prophylaxis (on and off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 1 Time to first alleviation of symptoms in adult treatment (days).
Figuras y tablas -
Analysis 3.1

Comparison 3 Zanamivir versus placebo for treatment, Outcome 1 Time to first alleviation of symptoms in adult treatment (days).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 2 Complications: pneumonia in adult treatment.
Figuras y tablas -
Analysis 3.2

Comparison 3 Zanamivir versus placebo for treatment, Outcome 2 Complications: pneumonia in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 3 Complications: pneumonia confirmed with X‐ray in adult treatment.
Figuras y tablas -
Analysis 3.3

Comparison 3 Zanamivir versus placebo for treatment, Outcome 3 Complications: pneumonia confirmed with X‐ray in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 4 Complications: bronchitis in adult treatment.
Figuras y tablas -
Analysis 3.4

Comparison 3 Zanamivir versus placebo for treatment, Outcome 4 Complications: bronchitis in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 5 Complications: sinusitis in adult treatment.
Figuras y tablas -
Analysis 3.5

Comparison 3 Zanamivir versus placebo for treatment, Outcome 5 Complications: sinusitis in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 6 Complications: otitis media in adult treatment.
Figuras y tablas -
Analysis 3.6

Comparison 3 Zanamivir versus placebo for treatment, Outcome 6 Complications: otitis media in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 7 Complications in adult trials classified as serious or leading to study withdrawal.
Figuras y tablas -
Analysis 3.7

Comparison 3 Zanamivir versus placebo for treatment, Outcome 7 Complications in adult trials classified as serious or leading to study withdrawal.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 8 Proportion diagnosed as influenza‐infected in adult treatment.
Figuras y tablas -
Analysis 3.8

Comparison 3 Zanamivir versus placebo for treatment, Outcome 8 Proportion diagnosed as influenza‐infected in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 9 Proportion with four‐fold rise in antibody titre in adult treatment.
Figuras y tablas -
Analysis 3.9

Comparison 3 Zanamivir versus placebo for treatment, Outcome 9 Proportion with four‐fold rise in antibody titre in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 10 Proportion with positive culture at baseline in adult treatment.
Figuras y tablas -
Analysis 3.10

Comparison 3 Zanamivir versus placebo for treatment, Outcome 10 Proportion with positive culture at baseline in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 11 Serious adverse events in adult treatment.
Figuras y tablas -
Analysis 3.11

Comparison 3 Zanamivir versus placebo for treatment, Outcome 11 Serious adverse events in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 12 Adverse events leading to study withdrawal in adult treatment.
Figuras y tablas -
Analysis 3.12

Comparison 3 Zanamivir versus placebo for treatment, Outcome 12 Adverse events leading to study withdrawal in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 13 All withdrawals in adult treatment.
Figuras y tablas -
Analysis 3.13

Comparison 3 Zanamivir versus placebo for treatment, Outcome 13 All withdrawals in adult treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 14 Time to first alleviation of symptoms in children (days).
Figuras y tablas -
Analysis 3.14

Comparison 3 Zanamivir versus placebo for treatment, Outcome 14 Time to first alleviation of symptoms in children (days).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 15 Complications: pneumonia in child treatment.
Figuras y tablas -
Analysis 3.15

Comparison 3 Zanamivir versus placebo for treatment, Outcome 15 Complications: pneumonia in child treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 16 Complications: bronchitis in child treatment.
Figuras y tablas -
Analysis 3.16

Comparison 3 Zanamivir versus placebo for treatment, Outcome 16 Complications: bronchitis in child treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 17 Complications: sinusitis in child treatment.
Figuras y tablas -
Analysis 3.17

Comparison 3 Zanamivir versus placebo for treatment, Outcome 17 Complications: sinusitis in child treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 18 Complications: otitis media in child treatment.
Figuras y tablas -
Analysis 3.18

Comparison 3 Zanamivir versus placebo for treatment, Outcome 18 Complications: otitis media in child treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 19 Proportion diagnosed as influenza‐infected in child treatment.
Figuras y tablas -
Analysis 3.19

Comparison 3 Zanamivir versus placebo for treatment, Outcome 19 Proportion diagnosed as influenza‐infected in child treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 20 Proportion with four‐fold increase in antibodies in child treatment.
Figuras y tablas -
Analysis 3.20

Comparison 3 Zanamivir versus placebo for treatment, Outcome 20 Proportion with four‐fold increase in antibodies in child treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 21 Proportion with positive culture at baseline in child treatment.
Figuras y tablas -
Analysis 3.21

Comparison 3 Zanamivir versus placebo for treatment, Outcome 21 Proportion with positive culture at baseline in child treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 22 All withdrawals in child treatment.
Figuras y tablas -
Analysis 3.22

Comparison 3 Zanamivir versus placebo for treatment, Outcome 22 All withdrawals in child treatment.

Comparison 3 Zanamivir versus placebo for treatment, Outcome 23 Adverse events: nausea and vomiting in child treatment (on‐treatment).
Figuras y tablas -
Analysis 3.23

Comparison 3 Zanamivir versus placebo for treatment, Outcome 23 Adverse events: nausea and vomiting in child treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 24 Adverse events: diarrhoea in child treatment (on‐treatment).
Figuras y tablas -
Analysis 3.24

Comparison 3 Zanamivir versus placebo for treatment, Outcome 24 Adverse events: diarrhoea in child treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 25 Adverse events: gastrointestinal body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 3.25

Comparison 3 Zanamivir versus placebo for treatment, Outcome 25 Adverse events: gastrointestinal body system in child treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 26 Adverse events: respiratory body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 3.26

Comparison 3 Zanamivir versus placebo for treatment, Outcome 26 Adverse events: respiratory body system in child treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 27 Adverse events: neurological body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 3.27

Comparison 3 Zanamivir versus placebo for treatment, Outcome 27 Adverse events: neurological body system in child treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 28 Adverse events: ear, nose and throat body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 3.28

Comparison 3 Zanamivir versus placebo for treatment, Outcome 28 Adverse events: ear, nose and throat body system in child treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 29 Adverse events: skin body system in child treatment (on‐treatment).
Figuras y tablas -
Analysis 3.29

Comparison 3 Zanamivir versus placebo for treatment, Outcome 29 Adverse events: skin body system in child treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 30 Adverse events: gastrointestinal body system in child treatment (off‐treatment).
Figuras y tablas -
Analysis 3.30

Comparison 3 Zanamivir versus placebo for treatment, Outcome 30 Adverse events: gastrointestinal body system in child treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 31 Adverse events: ear nose and throat body system in child treatment (off‐treatment).
Figuras y tablas -
Analysis 3.31

Comparison 3 Zanamivir versus placebo for treatment, Outcome 31 Adverse events: ear nose and throat body system in child treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 32 Adverse events: nausea/vomiting in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.32

Comparison 3 Zanamivir versus placebo for treatment, Outcome 32 Adverse events: nausea/vomiting in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 33 Adverse events: diarrhoea in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.33

Comparison 3 Zanamivir versus placebo for treatment, Outcome 33 Adverse events: diarrhoea in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 34 Adverse events: dizziness in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.34

Comparison 3 Zanamivir versus placebo for treatment, Outcome 34 Adverse events: dizziness in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 35 Adverse events: headache in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.35

Comparison 3 Zanamivir versus placebo for treatment, Outcome 35 Adverse events: headache in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 36 Adverse events: cough in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.36

Comparison 3 Zanamivir versus placebo for treatment, Outcome 36 Adverse events: cough in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 37 Adverse events: gastrointestinal body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.37

Comparison 3 Zanamivir versus placebo for treatment, Outcome 37 Adverse events: gastrointestinal body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 38 Adverse events: respiratory body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.38

Comparison 3 Zanamivir versus placebo for treatment, Outcome 38 Adverse events: respiratory body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 39 Adverse events: neurological body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.39

Comparison 3 Zanamivir versus placebo for treatment, Outcome 39 Adverse events: neurological body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 40 Adverse events: ear, nose and throat body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.40

Comparison 3 Zanamivir versus placebo for treatment, Outcome 40 Adverse events: ear, nose and throat body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 41 Adverse events: skin body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.41

Comparison 3 Zanamivir versus placebo for treatment, Outcome 41 Adverse events: skin body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 42 Adverse events: musculoskeletal body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.42

Comparison 3 Zanamivir versus placebo for treatment, Outcome 42 Adverse events: musculoskeletal body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 43 Adverse events: eye body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.43

Comparison 3 Zanamivir versus placebo for treatment, Outcome 43 Adverse events: eye body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 44 Adverse events: hepato body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.44

Comparison 3 Zanamivir versus placebo for treatment, Outcome 44 Adverse events: hepato body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 45 Adverse events: renal body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.45

Comparison 3 Zanamivir versus placebo for treatment, Outcome 45 Adverse events: renal body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 46 Adverse events: cardiovascular body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.46

Comparison 3 Zanamivir versus placebo for treatment, Outcome 46 Adverse events: cardiovascular body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 47 Adverse events: blood body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.47

Comparison 3 Zanamivir versus placebo for treatment, Outcome 47 Adverse events: blood body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 48 Adverse events: psychiatric body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.48

Comparison 3 Zanamivir versus placebo for treatment, Outcome 48 Adverse events: psychiatric body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 49 Adverse events: reproduction body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.49

Comparison 3 Zanamivir versus placebo for treatment, Outcome 49 Adverse events: reproduction body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 50 Adverse events: endocrine and metabolic body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.50

Comparison 3 Zanamivir versus placebo for treatment, Outcome 50 Adverse events: endocrine and metabolic body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 51 Adverse events: injury body system in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.51

Comparison 3 Zanamivir versus placebo for treatment, Outcome 51 Adverse events: injury body system in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 52 Adverse events: non‐site specific events in adult treatment (on‐treatment).
Figuras y tablas -
Analysis 3.52

Comparison 3 Zanamivir versus placebo for treatment, Outcome 52 Adverse events: non‐site specific events in adult treatment (on‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 53 Adverse events: nausea/vomiting in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.53

Comparison 3 Zanamivir versus placebo for treatment, Outcome 53 Adverse events: nausea/vomiting in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 54 Adverse events: cough in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.54

Comparison 3 Zanamivir versus placebo for treatment, Outcome 54 Adverse events: cough in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 55 Adverse events: respiratory body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.55

Comparison 3 Zanamivir versus placebo for treatment, Outcome 55 Adverse events: respiratory body system in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 56 Adverse events: headache in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.56

Comparison 3 Zanamivir versus placebo for treatment, Outcome 56 Adverse events: headache in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 57 Adverse events: diarrhoea in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.57

Comparison 3 Zanamivir versus placebo for treatment, Outcome 57 Adverse events: diarrhoea in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 58 Adverse events: fatigue in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.58

Comparison 3 Zanamivir versus placebo for treatment, Outcome 58 Adverse events: fatigue in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 59 Adverse events: gastrointestinal body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.59

Comparison 3 Zanamivir versus placebo for treatment, Outcome 59 Adverse events: gastrointestinal body system in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 60 Adverse events: neurological body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.60

Comparison 3 Zanamivir versus placebo for treatment, Outcome 60 Adverse events: neurological body system in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 61 Adverse events: ear, nose and throat in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.61

Comparison 3 Zanamivir versus placebo for treatment, Outcome 61 Adverse events: ear, nose and throat in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 62 Adverse events: skin body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.62

Comparison 3 Zanamivir versus placebo for treatment, Outcome 62 Adverse events: skin body system in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 63 Adverse events: musculoskeletal body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.63

Comparison 3 Zanamivir versus placebo for treatment, Outcome 63 Adverse events: musculoskeletal body system in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 64 Adverse events: non‐site specific in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.64

Comparison 3 Zanamivir versus placebo for treatment, Outcome 64 Adverse events: non‐site specific in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 65 Adverse events: injury body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.65

Comparison 3 Zanamivir versus placebo for treatment, Outcome 65 Adverse events: injury body system in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 66 Adverse events: endocrine and metabolic body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.66

Comparison 3 Zanamivir versus placebo for treatment, Outcome 66 Adverse events: endocrine and metabolic body system in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 67 Adverse events: eye body system in adult treatment (off‐treatment).
Figuras y tablas -
Analysis 3.67

Comparison 3 Zanamivir versus placebo for treatment, Outcome 67 Adverse events: eye body system in adult treatment (off‐treatment).

Comparison 3 Zanamivir versus placebo for treatment, Outcome 68 Time to first alleviation of symptoms in adults with/without relief medication [days].
Figuras y tablas -
Analysis 3.68

Comparison 3 Zanamivir versus placebo for treatment, Outcome 68 Time to first alleviation of symptoms in adults with/without relief medication [days].

Comparison 3 Zanamivir versus placebo for treatment, Outcome 69 Time to first alleviation of symptoms in adults by infection status [days].
Figuras y tablas -
Analysis 3.69

Comparison 3 Zanamivir versus placebo for treatment, Outcome 69 Time to first alleviation of symptoms in adults by infection status [days].

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 1 Symptomatic influenza in prophylaxis of individuals.
Figuras y tablas -
Analysis 4.1

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 1 Symptomatic influenza in prophylaxis of individuals.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 2 Asymptomatic influenza in prophylaxis of individuals.
Figuras y tablas -
Analysis 4.2

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 2 Asymptomatic influenza in prophylaxis of individuals.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 3 Symptomatic influenza in post‐exposure prophylaxis.
Figuras y tablas -
Analysis 4.3

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 3 Symptomatic influenza in post‐exposure prophylaxis.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 4 Asymptomatic influenza in post‐exposure prophylaxis.
Figuras y tablas -
Analysis 4.4

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 4 Asymptomatic influenza in post‐exposure prophylaxis.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 5 Complications: pneumonia in adult prophylaxis.
Figuras y tablas -
Analysis 4.5

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 5 Complications: pneumonia in adult prophylaxis.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 6 Complications: bronchitis in adult prophylaxis.
Figuras y tablas -
Analysis 4.6

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 6 Complications: bronchitis in adult prophylaxis.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 7 Complications: sinusitis in adult prophylaxis.
Figuras y tablas -
Analysis 4.7

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 7 Complications: sinusitis in adult prophylaxis.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 8 Complications classified as serious or leading to study withdrawal.
Figuras y tablas -
Analysis 4.8

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 8 Complications classified as serious or leading to study withdrawal.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 9 Serious adverse events in adult prophylaxis.
Figuras y tablas -
Analysis 4.9

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 9 Serious adverse events in adult prophylaxis.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 10 Adverse events leading to study withdrawal in adult prophylaxis.
Figuras y tablas -
Analysis 4.10

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 10 Adverse events leading to study withdrawal in adult prophylaxis.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 11 All withdrawals in adult prophylaxis.
Figuras y tablas -
Analysis 4.11

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 11 All withdrawals in adult prophylaxis.

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 12 Adverse events: abdominal pain in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.12

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 12 Adverse events: abdominal pain in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 13 Adverse events: cough in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.13

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 13 Adverse events: cough in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 14 Adverse events: diarrhoea in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.14

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 14 Adverse events: diarrhoea in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 15 Adverse events: dizziness in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.15

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 15 Adverse events: dizziness in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 16 Adverse events: fatigue in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.16

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 16 Adverse events: fatigue in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 17 Adverse events: headache in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.17

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 17 Adverse events: headache in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 18 Adverse events: blood body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.18

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 18 Adverse events: blood body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 19 Adverse events: nausea/vomiting in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.19

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 19 Adverse events: nausea/vomiting in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 20 Adverse events: cardiovascular body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.20

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 20 Adverse events: cardiovascular body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 21 Adverse events: ear, nose and throat body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.21

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 21 Adverse events: ear, nose and throat body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 22 Adverse events: endocrine and metabolic body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.22

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 22 Adverse events: endocrine and metabolic body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 23 Adverse events: eye body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.23

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 23 Adverse events: eye body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 24 Adverse events: gastrointestinal body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.24

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 24 Adverse events: gastrointestinal body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 25 Adverse events: injury body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.25

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 25 Adverse events: injury body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 26 Adverse events: musculoskeletal body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.26

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 26 Adverse events: musculoskeletal body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 27 Adverse events: neurological body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.27

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 27 Adverse events: neurological body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 28 Adverse events: non‐site specific in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.28

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 28 Adverse events: non‐site specific in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 29 Adverse events: psychiatric body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.29

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 29 Adverse events: psychiatric body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 30 Adverse events: renal body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.30

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 30 Adverse events: renal body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 31 Adverse events: reproductive body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.31

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 31 Adverse events: reproductive body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 32 Adverse events: respiratory body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.32

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 32 Adverse events: respiratory body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 33 Adverse events: skin body system in adult prophylaxis (on‐treatment).
Figuras y tablas -
Analysis 4.33

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 33 Adverse events: skin body system in adult prophylaxis (on‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 34 Adverse events: gastrointestinal body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.34

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 34 Adverse events: gastrointestinal body system in adult prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 35 Adverse events: respiratory body system in adult prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.35

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 35 Adverse events: respiratory body system in adult prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 36 Adverse events: nausea/vomiting in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.36

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 36 Adverse events: nausea/vomiting in prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 37 Adverse events: diarrhoea in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.37

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 37 Adverse events: diarrhoea in prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 38 Adverse events: headache in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.38

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 38 Adverse events: headache in prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 39 Adverse events: cough in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.39

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 39 Adverse events: cough in prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 40 Adverse events: fatigue in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.40

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 40 Adverse events: fatigue in prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 41 Adverse events: neurological body system in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.41

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 41 Adverse events: neurological body system in prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 42 Adverse events: ear, nose and throat in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.42

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 42 Adverse events: ear, nose and throat in prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 43 Adverse events: musculoskeletal body system in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.43

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 43 Adverse events: musculoskeletal body system in prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 44 Adverse events: non‐site specific in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.44

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 44 Adverse events: non‐site specific in prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 45 Adverse events: injury in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.45

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 45 Adverse events: injury in prophylaxis (off‐treatment).

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 46 Adverse events: endocrine and metabolic in prophylaxis (off‐treatment).
Figuras y tablas -
Analysis 4.46

Comparison 4 Zanamivir versus placebo for prophylaxis, Outcome 46 Adverse events: endocrine and metabolic in prophylaxis (off‐treatment).

Comparison 5 Neuraminidase inhibitor versus placebo for treatment or prophylaxis, Outcome 1 Complications: pneumonia.
Figuras y tablas -
Analysis 5.1

Comparison 5 Neuraminidase inhibitor versus placebo for treatment or prophylaxis, Outcome 1 Complications: pneumonia.

Table 1. Blank case report forms' data capture for secondary illnesses in oseltamivir trials

Study

Where in CRF (PDF pg #)

Data captured

Person reporting

(participant/investigator)

Where reported

Specific field for recording confirmatory assessment (e.g. CXR)

Confirmation (including px)

M76001

1167

Yes/no answer to question: "Is this event a secondary illness related to influenza?"

Secondary illness is defined: sinusitis, otitis, bronchitis, pneumonia + other chest infections that are not diagnosed as bronchitis and/or pneumonia

Investigator

In form for "Adverse events or intercurrent illness"

No

Px

NV16871

361, 389

Form states:

Have there been any changes in the patient’s health including any new conditions or worsening of existing conditions since day 1 (please include secondary illnesses)?

Yes/No. If "Yes", please record the details on the "Adverse events or secondary illness" form in the Additional Forms section of the CRF on pg 30.0. All serious adverse events must be reported within 1 working day of occurrence to Roche

Pg 30.0 of CRF (PDF pg 389) defines secondary illnesses as sinusitis, otitis media, bronchitis and pneumonia, and asks additional questions such as relationship to test drug and outcome, and leaves space for investigator's comments on the adverse event

Investigator

Secondary illness not listed as efficacy outcomes

Recording of secondary illnesses was to occur in a form titled "Adverse event or secondary illness"

No

Px

WV15670

732, 754, 791, 832

CRF form (PDF pg 732) states:

Secondary illness reminder

Has the patient reported any sinusitis, otitis, bronchitis, other chest infection or pneumonia since baseline?

yes [ ] Complete secondary illness page (not the adverse event page)

no [ ]

Secondary illness page CRF (PDF pg 754) requests information on date of onset, date resolved, whether treatment was given and, if so, what treatment or medical procedures, total daily dose, and start/end date of treatment or medical procedure

In addition, participants could fill in information related to a secondary illness in their diary card in the free‐text box called "Notes" which prompts participants: "Please can you record below any extra information about your flu which may be of interest to us, (for example: did your flu symptoms re‐occur, and if so when?), and have you taken any other treatments. If so please record the treatment name and the dates you took it." (PDF pg 791)

Participant mediated through Investigator

For investigators, on "Secondary illness" form

For participants, on "Notes" section of diary card

No

WV15671

740, 889, 1018

CRF form (PDF pg 740) states:

Secondary illness reminder

Has the patient reported any sinusitis, otitis, bronchitis, other chest infection or pneumonia since baseline?

yes [ ] Complete secondary illness page (not the adverse event page)

no [ ]

Secondary illness page CRF (PDF pg 889) requests information on date of onset, date resolved, whether treatment was given and, if so, what treatment or medical procedures, total daily dose and start/end date of treatment or medical procedure

Secondary illnesses are listed as sinusitis, otitis, bronchitis, pneumonia and other chest infections that are not diagnosed as bronchitis and/or pneumonia

In addition, participants could fill in information related to a secondary illness in their diary card in the free‐text box called "Notes" which prompts participants: "Please can you record below any extra information about your flu which may be of interest to us, (for example: did your flu symptoms re‐occur, and if so when?), and have you taken any other treatments. If so please record the treatment name and the dates you took it." (PDF pg 1018)

Participant mediated through investigator

Mentioned in M1 and RAP as tertiary outcomes not mentioned in protocol

No

Px

WV15673/WV15697

From 483

No mention of pneumonia, secondary illness, complications in the CRFs

Unclear

Secondary illnesses not listed in protocol as endpoints. They are listed as safety endpoints in the RAP which states that "pre‐defined" secondary illnesses were "sinusitis, otitis, bronchitis, pneumonia, and other chest infections that are not diagnosed as bronchitis and/or pneumonia, plus recurrence of symptoms from the diary card once alleviation had occurred." (PDF pg 479)

WV15707

From 98

Pg 117 Secondary illness reminder: Has the patient reported any sinusitis, otitis, bronchitis, other chest infection or pneumonia since baseline?

yes [] ‐ Complete secondary illness page (not the adverse event page)

no []

Pg 131: Diagnostic procedures

1) Were there any diagnostic procedures or tests carried out since day 1 as a result of influenza or secondary illness that were not scheduled as part of protocol?
Yes

Type of diagnostic procedure or test

1 Chest X‐rays, 2 ECG, 3 Bacterial culture, 4 Bronchoscopy, 5 Pulmonary function test, 6 Viral culture (other than influenza), 7 Blood tests (other than antibody sample), 8 Other specify

No

Secondary illness page CRF (PDF pg 158) requests information on date of onset, date resolved, whether treatment was given and, if so, what treatment or medical procedures, total daily dose and start/end date of treatment or medical procedure

Participant mediated through investigator

Mentioned in RAP as tertiary endpoints pg 57‐8

Yes

Px

WV15708

From 460

Secondary illness reminder at pg 474:

Has the patient reported any new episodes of sinusitis, otitis, bronchitis, other chest infection or pneumonia since screening?

yes [] ... Complete adverse event page

no []

"Adverse events" CRF collected data on date of onset, initial intensity, test drug adjustment, whether treatment was given (if so, what), most extreme intensity, relationship to test drug, outcome, whether it led to hospitalisation and a free‐text line for recording "Comments on AE" (e.g. PDF pg 479)

Participant mediated through investigator

Secondary illness not mentioned in protocol

No

Px

WV15730

From 340

Secondary illness reminder:

Has the patient reported any sinusitis, otitis, bronchitis, other chest infection or pneumonia since baseline?

yes [] ... Complete secondary illness page (not the adverse event page)

no []

The secondary illness page is descriptive of dates and px

Participant mediated through investigator

Listed as tertiary endpoints in RAP at pg 297

No

Px

WV15758

From 637

Has the patient reported any new adverse events or symptoms (including intercurrent illnesses and secondary illnesses)?

yes [] record in the adverse events/intercurrent illness section of the case

no [] report form

Diagnostic confirmation of otitis media from pg 648 onwards

Participant mediated through investigator

Listed as secondary illnesses in core report Module 1‐2 (pg 36)

Yes

Px

WV15759/871

From 665

Has the subject reported any adverse events including secondary and intercurrent illnesses?

Participant mediated through investigator

Secondary illnesses not mentioned in protocol, but secondary outcome in core report

Note: worth looking at comparisons 1.49 to 1.51 in RM5. No effect but in bronchitis this study has a more conservative effect than NV 16871 which has no definitions and no diagnostics

Yes

Px

WV15799

From 642

Secondary illness defined as in M76001. There is a generic physical examination form at pg 704 including "lungs" normal/abnormal specify_______

At pg 709 has the patient reported any new AE including intercurrent or secondary illnesses yes/no. If y record the adverse events/intercurrent illness section of the CRF (noted at pf 746 on to be at the back of the CRF) with FULL HISTORY, PHYSICAL EXAMINATION AND DIAGNOSTIC WORK UP QUESTIONS FOR BRON+PNUM+LRTI+SIN+OM including questions about CXR, MRI, sputum etc.

Investigator

Proportion of contacts who are classified as having a secondary illness subsequent to a confirmed episode of influenza listed as tertiary endpoints

Yes

Px

WV15812/872

From 285

Has the patient reported any new adverse events or symptoms (including intercurrent illnesses and secondary illnesses)?

yes [] record in the adverse events/intercurrent illness section of the case

no [] report form

At pg 450‐74 is DIAGNOSIS OF SECONDARY ILLNESS page which is very similar to the one at serial 10

EXHAUSTIVE list of diagnostic procedures

Participant mediated through investigator

Listed as secondary tertiary in protocol at pg 252

Yes

Px

WV15819/978/876

From 412

Pg 437 (adverse event reminder):

Has the patient reported any new adverse events or symptoms (including intercurrent illnesses)?

yes [] record in the adverse events/intercurrent illness section of the case

no [] report form

In CRF pg 447 and 443 usual secondary illness reminder

From pg 471 DIAGNOSTIC OF SECONDARY ILLNESS. This is a one page list of diagnostics similar to that at serial 10. The question is: "Were there any diagnostic procedures or tests carried out since day 1 as a result of influenza or secondary illness that were not scheduled as part of protocol?" If yes list per serial 10

From pg 486 is a list of diagnostic tests

Participant mediated through investigator

Secondary illness listed as secondary (required antibiotics) and tertiary outcomes in core report and as an addition in protocol amendment at pg 21

Yes

Px

WV15825

From 389

There is a usual note: please go to diagnosis of secondary illness at back of CRF. Pg 487:

Is this event a secondary illness related to influenza?

DIAGNOSTIC OF SECONDARY ILLNESS

From pg 510‐40 with exhaustive list of diagnostics as per serial 10

Participant mediated through investigator

Secondary illness listed as secondary outcomes in protocol pg 346

Secondary illnesses recorded on "Adverse events" CRF

Yes

Px

WV16277

From 415

Not found

Not found

Secondary illness not listed as efficacy outcomes

#Events within the first 2 days of the study were excluded
*Note that some events are reported as secondary illness and adverse event (AE) but some events are reported as secondary illness only and some events are reported as adverse event only
BRON = bronchitis
CRF = case report form
CXR = chest x‐ray
ECG = electrocardiogram
LRTI = lower respiratory tract infection
MRI = magnetic resonance imaging
OM = otitis media
PNUM = pneumonia
px = prescription
˜RAP = reporting analysis plan
SIN = sinusitis

Figuras y tablas -
Table 1. Blank case report forms' data capture for secondary illnesses in oseltamivir trials
Table 2. Table of contents for studies of zanamivir described in regulatory documentation from the FDA (USA)

Mentioned study

File name

Pages where study is mentioned (separated by commas)

Note

113502

 

 

 

113625

 

 

 

113678

 

 

 

114045

 

 

 

NAI108166

 

 

 

105934

 

 

 

NAI106784

 

 

 

107485

 

 

 

108127

 

 

 

112311

 

 

 

112312

 

 

 

113268

 

 

 

GCP/95/045

 

 

 

NAI10901

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin2.pdf

15.15

 

NAI10902

 

 

 

NAI30008

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin2.pdf

15

7 documents with 14 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin3.pdf

13

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview7.pdf

19, 19, 20

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview8.pdf

1, 1, 3, 4, 4

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview9.pdf

7.7

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/21036ltr.pdf

2

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_MEDR.pdf

33

 

NAI30009

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview8.pdf

1.2

7 documents with 110 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_ADMINCORRES_P1.pdf 

10, 10, 12, 13, 13, 14, 14, 17, 29, 42, 61, 62, 64, 64, 65, 65, 68

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_ADMINCORRES_P2.pdf 

33, 34, 36, 43, 43, 43, 43, 52, 52, 52, 53, 53, 56, 57

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_BIOPHARMR.pdf

5, 5, 5, 6, 6, 8, 8

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_MEDR.pdf

3, 3, 3, 3, 3, 3, 3, 4, 4, 5, 8, 9, 9, 10, 10, 11, 11, 11, 14, 14, 15, 16, 17, 19, 19, 19, 20, 20, 22, 23, 23, 23, 24, 24, 24, 25, 25, 25, 25, 25, 25, 26, 26, 26, 27, 27, 28, 28, 28, 29, 29, 31, 31, 31, 31

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_MICROBR.pdf

3, 3, 4, 4, 4

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_STATR.pdf

2, 2, 2, 4, 7, 12, 18, 18, 18, 19

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_ADMINCORRES_P1.pdf

31.56

1 document with 2 instances

NAI30010

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview8.pdf

1.2

6 documents with 65 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_ADMINCORRES_P1.pdf 

10, 12, 13, 14, 14, 15, 17, 62, 62, 62, 64

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_ADMINCORRES_P2.pdf 

34, 34, 36, 43, 53

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_BIOPHARMR.pdf

5, 5, 6, 6

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_MEDR.pdf

3, 3, 3, 3, 3, 4, 5, 18, 19, 21, 21, 22, 23, 23, 23, 23, 24, 25, 25, 25, 26, 26, 26, 26, 27, 27, 27, 28, 28, 29, 29, 29, 30, 31, 31, 31, 32

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_STATR.pdf

2, 2, 13, 13, 13, 19

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_BIOPHARMR.pdf

6

1 document with 1 instance

NAI30012

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview7.pdf

1

1 document with 1 instance

NAI30015

 

 

 

NAI30020

 

 

 

NAI30028

 

 

 

NAI30034

 

 

 

NAI40012

 

 

 

NAIA1009

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_ADMINCORRES_P1.pdf

56

4 documents with 17 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_ADMINCORRES_P2.pdf 

1, 1, 1, 48, 49, 52

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_BIOPHARMR.pdf

5, 5, 6

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_MEDR.pdf

3, 3, 6, 7, 20, 31, 31

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview5.pdf

18

5 documents with 5 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview6.pdf

9

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_ADMINCORRES_P2.pdf 

52

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_BIOPHARMR.pdf

11

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_STATR.pdf

2

 

NAIA3002

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin1.pdf

15

13 documents with 122 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin2.pdf

6, 6, 7, 7, 14, 15, 22, 22, 23

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin3.pdf

1, 4, 4, 12, 12, 12, 12, 17

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview1.pdf

4, 14, 14, 14, 14, 14, 15, 15, 15, 15, 16

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview2.pdf

1, 2, 3, 4, 4, 5, 6, 6, 6, 8, 8, 9, 9, 9, 12, 12, 15, 16, 16, 16, 17

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview3.pdf

5, 5, 6, 6, 6, 7, 7, 7, 8, 8, 9, 9, 9, 10, 11, 12, 13, 13, 14, 15, 15, 17, 18, 18, 19, 20, 21

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview4.pdf

1, 1, 1, 1, 2, 6

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview6.pdf

4, 5, 10, 12

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview7.pdf

1, 1, 2, 2, 2, 2, 3, 3, 4, 4, 5, 5, 7, 8, 10, 11, 12, 14, 16, 16, 16, 16, 16, 17

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview8.pdf

2, 2, 6, 6, 8, 8, 9, 10

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview9.pdf

10

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐stats.pdf

7

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_BIOPHARMR.pdf

5

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview1.pdf

15

1 document with 1 instance

NAIA3003

 

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview7.pdf

17, 17, 18

3 documents with 6 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview8.pdf

4.4

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview9.pdf

22

 

NAIA3004

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin3.pdf

14

4 documents with 8 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview6.pdf

7

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview7.pdf

18, 18, 19

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview8.pdf

4, 4, 4

 

NAIA3005

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin3.pdf

14

5 documents with 12 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview1.pdf

5

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview5.pdf

12, 12, 12, 13, 14, 15, 15

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview7.pdf

14.15

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_ADMINCORRES_P2.pdf 

38

 

NAIB1002

 

 

 

NAIB3002

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin1.pdf

15

14 documents with 99 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin2.pdf

14, 15, 15, 15

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin3.pdf

11.12

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview1.pdf

4, 14, 14, 14, 14, 14, 14, 14, 14

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview2.pdf

9, 9, 9, 9, 9, 9, 10, 11, 12, 12, 12, 12, 13, 13, 13, 14, 14, 14, 15, 15, 16, 16, 16, 17

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview3.pdf

4, 5, 6, 6, 6, 7, 7, 7, 8, 8, 8, 9, 9, 11, 12, 12, 13, 13, 14, 15, 17, 18, 18, 19, 20, 21

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview4.pdf

1, 1, 1, 1, 2

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview5.pdf

4

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview6.pdf

4, 5, 10, 12

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview7.pdf

2, 3, 3, 7, 8, 10, 11, 14, 15, 16, 16, 16

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview8.pdf

7, 8, 8, 8, 9, 9

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview9.pdf

10.2

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐stats.pdf

7

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_BIOPHARMR.pdf

5.5

 

NAI30011

 

 

 

NAIB2007

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin1.pdf

15

7 documents with 18 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin2.pdf

15

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview1.pdf

5

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview4.pdf

14, 15, 15, 16, 16, 17, 17, 17, 18

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview6.pdf

3

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview7.pdf

8, 10, 10, 15

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview8.pdf

2

 

NAIA2006

 

 

 

NAIB2006

 

 

 

NAIB1007

 

 

 

C94‐009

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview5.pdf

17

1 document with 1 instance

C94‐085

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview5.pdf

17

2 documents with 2 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview9.pdf

22

 

NAIB1001

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_BIOPHARMR.pdf

17

1 document with 1 instance

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/20000426_001/21‐036‐S001_RELENZA_BIOPHARMR.pdf

6

1 document with 1 instance

NAIA2005

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin1.pdf

15

10 documents with 44 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin2.pdf

7, 17, 10

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin3.pdf

2.4

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview1.pdf

4.5

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview4.pdf

2, 2, 3, 3, 3, 3, 5, 6, 6, 6, 6, 8, 8, 8, 9, 11, 12, 12, 13, 14, 14, 14, 14, 14, 15, 18

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview5.pdf

7.7

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview6.pdf

3.4

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview7.pdf

2, 5, 9, 15

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview8.pdf

10

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐microbiology.pdf

21

 

NAIB2005

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin1.pdf

15

9 documents with 43 instances

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐admin2.pdf

17, 20, 20, 22, 23

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview1.pdf

5.5

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview4.pdf

3, 3, 3, 7, 8, 8, 8, 9, 10, 11, 11, 11, 11, 11, 12, 12, 12, 13, 14, 14, 14, 14, 14, 14, 14, 15

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview5.pdf

7.7

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview6.pdf

3.4

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview7.pdf

2, 9, 15

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview8.pdf

2

 

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐microbiology.pdf

21

 

NAIA/B2008

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview6.pdf

4

1 document with 1 instance

NAIA2010

Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036‐medreview5.pdf

16

1 document with 1 instance

NAIA/B2009

 

 

 

167‐02

 

 

 

167‐03

 

 

 

167‐05

 

 

 

167‐04

 

 

 

JNAI‐03

 

 

 

JNAI‐02

 

 

 

JNAI‐01

 

 

 

JNAI‐07

 

 

 

JNAI‐04

 

 

 

PE‐01

 

 

 

167‐101

 

 

 

167T3‐11 

 

 

 

Zanamivir trials citation by trial ID and source FDA file. Page numbers separated by commas (where applicable) indicate which trial is cited where in which regulatory file. Blank spaces indicate no citation for known trials.

All the studies have been searched in the folder "Tamiflu and Relenza/Relenza/Relenza ‐ NDA 021036/19990726_000/021036". File name is left blank when the study was not present in that folder.

Figuras y tablas -
Table 2. Table of contents for studies of zanamivir described in regulatory documentation from the FDA (USA)
Table 3. Table of contents for studies of oseltamivir described in regulatory documentation from the FDA (USA)

Referenced study

File name

Pages where study is mentioned (separated by commas)

Note

NP15717

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_bior.pdf

46.46

6 documents with 13 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

14, 15, 15

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

3

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Admindocs_P2.pdf

2

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_BioPharmr.pdf

5, 8, 10, 13, 31

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

3

 

NP15718

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_bior.pdf

17

1 document with 1 instance

NP15728 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_bior.pdf

16.35

3 documents with 6 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

11

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

45, 46, 47

 

NP15757

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20001117_002/21‐087SE1‐002_review.pdf

92, 93, 104, 122, 126, 131, 144, 144, 145

1 document with 9 instances

NP15826 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

47

9 documents with 26 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20040624_016/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_ADMINCORRES.pdf

6

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

3

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Admindocs_P2.pdf

2

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_BioPharmr.pdf

4, 5, 5, 8, 8, 8, 10, 17, 29, 30, 30, 30, 30, 30, 31, 31

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Medr.pdf

9.1

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Statr.pdf

9.1

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20040624_016/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_ADMINCORRES.pdf

6

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

3

 

NP15827 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

10.12

2 documents with 7 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

16, 16, 17, 17, 17

 

WP15525 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_bior.pdf

21, 25, 26, 27, 27, 27, 27, 42, 42, 44

3 document with 13 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Admindocs_P2.pdf

2.2

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_BioPharmr.pdf

29

 

WP15647

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_bior.pdf

24, 27, 27

2 documents with 4 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

44

 

WP15648 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_bior.pdf

39

3 documents with 8 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

44.44

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20001117_002/21‐087SE1‐002_review.pdf

94, 128, 153, 153, 154

 

WP15676 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_bior.pdf

28.33

3 documents with 4 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

11

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

45

 

WV15670 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_bior.pdf

2, 44, 44

6 documents with 45 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

6, 19, 37, 38, 39, 39, 39, 39, 40, 41, 41, 42, 43, 44, 48, 48, 49, 49

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

1, 25, 25, 35, 35, 39, 39, 47

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Statr.pdf

3, 3, 4, 4, 5, 5, 5, 8, 9, 10, 17, 17, 21, 22,

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20001117_002/21‐087SE1‐002_review.pdf

189

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

3

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

3

 

WV15671 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_bior.pdf

2, 44, 44

7 documents with 50 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

6, 16, 19, 24, 24, 25, 25, 26, 27, 27, 28, 32, 34, 35, 36, 37, 38, 39, 39, 39, 40, 41, 46, 49, 49

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

1, 25, 25, 35, 38, 47

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Statr.pdf

3, 4, 4, 5, 5, 5, 5, 9, 10, 10, 15, 17, 21

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20001117_002/21‐087SE1‐002_review.pdf

189

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

3

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

3

 

WV15673 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

3

3 documents with 50 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

18, 18, 18, 20, 21, 21, 21, 22, 39

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20001117_002/21‐087SE1‐002_review.pdf

58, 59, 71, 71, 71, 71, 71, 72, 72, 73, 73, 76, 76, 76, 76, 76, 77, 77, 79, 82, 83, 83, 84, 122, 124, 125, 126, 128, 131, 131, 132, 133, 134, 134, 145, 145, 156, 169, 177, 189

 

WV15697 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

39

2 documents with 40 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20001117_002/21‐087SE1‐002_review.pdf

58, 59, 71, 71, 71, 71, 71, 72, 72, 73, 73, 76, 76, 76, 76, 76, 77, 77, 79, 82, 83, 83, 84, 122, 126, 128, 131, 131, 131, 132, 133, 134, 145, 145, 152, 153, 156, 162, 189

 

WV15708 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

3

3 documents with 39 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

23, 35, 39, 41

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20001117_002/21‐087SE1‐002_review.pdf

71, 71, 71, 71, 71, 72, 72, 72, 72, 75, 75, 75, 75, 77, 77, 78, 79, 79, 82, 82, 122, 125, 125, 126, 131, 134, 134, 135, 135, 149, 151, 152, 152, 153

 

WV15708D 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

3

2 documents with 3 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

23.35

 

WV15730 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_bior.pdf

44.44

5 documents with 15 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

6, 9, 19, 49, 50, 50

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

1, 1, 25, 25, 27

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20001117_002/21‐087SE1‐002_review.pdf

189

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

3

 

WV15731 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Admindocs_P2.pdf

17

4 documents with 9 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Medr.pdf

5, 30, 37

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Microbr.pdf

5.6

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Statr.pdf

5, 30, 37

 

WV15758 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Admindocs_P1.pdf

12, 19, 19, 36

9 documents with 92 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Admindocs_P2.pdf

2, 8, 17, 39, 39, 57, 57

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_BioPharmr.pdf

3, 4, 5, 5, 5, 8, 10, 17, 27, 30

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Corres.pdf

6.9

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Medr.pdf

5, 5, 9, 9, 10, 11, 12, 12, 16, 18, 18, 18, 19, 19, 31, 31, 31, 33, 33, 35, 36, 37, 37, 37, 37, 37, 37, 37, 40, 43

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Microbr.pdf

2, 4, 5, 6

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Statr.pdf

5, 5, 9, 9, 10, 11, 12, 12, 16, 18, 18, 18, 19, 19, 31, 31, 31, 33, 33, 35, 36, 37, 37, 37, 37, 37, 37, 37, 40, 43

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20040624_016/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_ADMINCORRES.pdf

6, 6, 8

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

2.3

 

WV15759 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Admindocs_P1.pdf

12.13

7 documents with 44 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Admindocs_P2.pdf

39

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Medr.pdf

5, 10, 30, 30, 30, 30, 31, 32, 32, 33, 34, 37, 37, 37, 40, 44

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Microbr.pdf

2, 4, 4, 5, 6

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Statr.pdf

5, 10, 30, 30, 30, 30, 31, 32, 32, 33, 34, 37, 37, 37, 40, 44

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20040624_016/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_ADMINCORRES.pdf

6, 6, 9

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

2

 

WV15799 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20001117_002/21‐087SE1‐002_review.pdf

28, 28, 28, 28, 28, 29, 29, 30, 30, 30, 30, 30, 31, 31, 31, 31, 32, 32, 32, 32, 32, 33, 33, 34, 34, 35, 35, 35, 36, 37, 37, 37, 37, 37, 38, 38, 38, 39, 39, 40, 40, 40, 40, 40, 58, 60, 71, 71, 71, 71, 71, 72, 72, 73, 76, 76, 76, 77, 78, 79, 84, 85, 122, 125, 125, 126, 126, 128, 131, 140, 140, 140, 143, 147, 149, 156, 162, 169, 175, 187, 203, 208, 208

4 documents with 89 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Medr.pdf

10.11

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Statr.pdf

10.11

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20040624_016/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_ADMINCORRES.pdf

6.7

 

WV15812 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

3, 6, 10, 12

2 documents with 9 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

6, 8, 10, 25, 35

 

WV15819 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P1.pdf

6, 10, 12, 15

2 documents with 8 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/19991027_000/21087_Tamiflu_medr_P2.pdf

2, 6, 6, 39

 

WV15825 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20001117_002/21‐087SE1‐002_review.pdf

41, 41, 41, 41, 42, 42, 42, 42, 42, 42, 43, 44, 58, 59, 71, 71, 71, 71, 71, 72, 72, 72, 72, 73, 73, 75, 75, 77, 77, 78, 79, 79, 79, 80, 80, 80, 81, 82, 85, 125, 125, 126, 126, 128, 131, 134, 134, 135, 135, 137, 137, 138, 145, 150, 151, 152, 152, 155, 156, 162, 169, 180, 204, 211

1 document with 64 instances

WV15871 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Admindocs_P1.pdf

12.13

7 documents with 42 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Admindocs_P2.pdf

39

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Medr.pdf

5, 11, 30, 31, 31, 32, 32, 32, 33, 34, 37, 37, 37, 37, 37, 37, 40

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Microbr.pdf

2, 5, 6

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Statr.pdf

5, 11, 30, 31, 31, 32, 32, 32, 33, 34, 37, 37, 37, 37, 37, 37, 40

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021087/20040624_016/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_ADMINCORRES.pdf

6

 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20040624_010/021087_S016_TAMIFLU CAPSULES ‐ DRY POWDER_BIOPHARMR.pdf

2

 

WV15872 

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Medr.pdf

11.33

2 documents with 4 instances

Tamiflu and Relenza/Tamiflu/Tamiflu ‐ NDA 021246/20001214_000/21‐246_Tamiflu_Statr.pdf

11.33

 

Oseltamivir trials citation by trial ID and source FDA file. Page numbers separated by commas (where applicable) indicate which trial is cited where in which regulatory file. Blank spaces indicate no citation for known trials.

Search strategy:
WV15758 OR WV 15758 OR Trial 15758 OR Trial15758 OR Trials 15758 OR Trials15758 OR 15758 OR study 15758 OR study15758

Figuras y tablas -
Table 3. Table of contents for studies of oseltamivir described in regulatory documentation from the FDA (USA)
Table 4. Table of contents for studies of zanamivir described in regulatory documentation from NICE (UK)

Mentioned study

File name

Pages where study is mentioned (separated by commas)

Note

NAI106784

 

 

 

107485

 

 

 

108127

 

 

 

112311

 

 

 

112312

 

 

 

113268

 

 

 

GCP/95/045

 

 

 

NAI10901

 

 

 

NAI10902

 

 

 

NAI30008

Relenza treatment submission executive summary.pdf

4

3 documents with 10 instances

Relenza treatment submission full document.pdf

5, 26, 26, 26, 146

 

Relenza treatment submission main text.pdf

5, 26, 26, 26

 

NAI30009

NAI30010 study report pdf\FINAL NAI30010 for sign‐off.pdf

102

7 documents with 461 instances

NAI30009 study report pdf\CSR30009.pdf

 

 

NAI30009 study report pdf\NAI 30009 HO final FSR.pdf

 

 

NAI30009 study report pdf\suptables.pdf

 

 

NAI30009 study report pdf\tables.pdf

 

 

Relenza treatment submission full document.pdf

16, 16, 17, 18, 18, 18, 18, 19, 27, 30, 31,

 

Relenza treatment submission main text.pdf

16, 16, 17, 18, 18, 18, 18, 19, 27, 30, 31, 76, 128, 130, 132, 134, 144

 

NAI30010

NAI30010 study report\Final NAI30010 for sign‐off.pdf

 

7 documents with 399 instances

NAI30010 study report pdf\NAI30010 HO final FSR.pdf

 

 

NAI30010 study report pdf\suptables.pdf

 

 

NAI30010 study report pdf\tables.pdf

 

 

Relenza prophylaxis submission.pdf

2, 5, 8, 11, 12, 19, 20, 21, 23, 24

 

Relenza treatment submission full document.pdf

16, 16, 17, 18, 18, 18, 27, 30, 31, 76, 135, 137, 139, 141, 143, 144

 

Relenza treatment submission main text.pdf

16, 16, 17, 18, 18, 18, 27, 30, 31

 

NAI30012

Relenza treatment submission executive summary.pdf

4

3 documents with 8 instances

NAI30012

Relenza treatment submission full document.pdf

5, 26, 26, 146

 

NAI30012

Relenza treatment submission main text.pdf

5, 26, 26

 

NAI30015

Relenza treatment submission full document.pdf

146

1 document with 1 instance

NAI30020

 

 

 

NAI30028

 

 

 

NAI30031

 

 

 

NAI30034

 

 

 

NAI40012

 

 

 

NAIA1009

 

NAI30010 study report pdf\FINAL NAI30010 for sign‐off.pdf

101

2 documents with 3 instances

NAI30009 study report pdf\CSR30009.pdf

28.34

 

NAIA3002

 

 

 

 

 

 

 

 

NAI30010 study report pdf\FINAL NAI30010 for sign‐off.pdf

102

9 documents with 513 instances

NAI30009 study report pdf\CSR30009.pdf

34.95

 

NAI30009 study report pdf\NAI30009 HO final FSR.pdf

22

 

NAIA3002 study report pdf\NAIA3002 full study report.pdf

 

 

NAIA3002 study report pdf\NAIA3002 supporting tables 2.pdf

 

 

NAIA3005 study report pdf\A3005cr01.pdf

25

 

NAIB3002 study report pdf\NAIB3002 full study report.pdf

28, 47, 49

 

Relenza treatment submission full document.pdf

16, 16, 17, 17, 18, 19, 27, 30, 31, 63, 63, 63, 76, 106, 106, 107, 107, 109, 109, 112, 112, 114, 114, 115, 115, 144

 

Relenza treatment submission main text.pdf

16, 16, 17, 17, 18, 19, 27, 30, 31

 

NAIA3003

Relenza prophylaxis submission.pdf

10

1 document with 1 instance

NAIA3004

Relenza prophylaxis submission.pdf

10

1 document with 1 instance

NAIA3005

NAI30010 study report pdf\FINAL NAI30010 for sign‐off.pdf

36, 94, 94, 94, 95, 96, 96, 101

5 documents with 310 instances

NAI30010 study report pdf\NAI30010 HO FSR.pdf

6.18

 

NAIA3005 study report pdf\A3005cr01.pdf

 

 

NAIA3005 study report pdf\TABS.pdf

 

 

Relenza prophylaxis submission.pdf

2, 5, 6, 12, 13, 13, 15, 15, 16, 16, 17, 17, 18, 18

 

NAIB1002

 

 

 

NAIB3001

NAI30009 study report pdf\CSR30009.pdf

34, 50, 95

11 documents with 374 instances

NAI30009 study report pdf\NAI 30009 HO final FSR.pdf

10.22

 

NAI30010 study report pdf\FINAL NAI30010 for sign‐off.pdf

102

 

NAI30010 study report pdf \NAI30010 HO FSR.pdf

17.17

 

NAIA3002 study report pdf\NAIA3002 full study report.pdf

28

 

NAIA3005 study report pdf\A3005cr01.pdf

25

 

NAIB3001 study report pdf\NAIB3001 full study report.pdf

 

 

NAIB3001 study report pdf\NAIB3001 supporting tables 1.pdf

 

 

NAIB3002 study report pdf\NAIB3002 full study report.pdf

28

 

Relenza treatment submission full document.pdf

16, 16, 17, 18, 18, 18, 18, 27, 30, 31, 32, 63, 63, 63, 76, 99, 99, 101, 101, 103, 103, 105, 105, 144, 162

 

Relenza treatment submission main text.pdf

16, 16, 17, 18, 18, 18, 18, 27, 30, 31, 32

 

NAIB3002

NAI30009 study report pdf\CSR30009.pdf

34.95

10 documents with 579 instances

NAI30009 study report pdf\NAI 30009 HO final FSR.pdf

22

 

NAI30010 study report pdf\FINAL NAI30010 for sign‐off.pdf

102

 

NAIA3002 study report pdf\NAIA3002 full study report.pdf

28, 48, 50

 

NAIA3005 study report pdf\A3005cr01.pdf

25

 

NAIB3002 study report pdf\NAIB3002 full study report.pdf

 

 

NAIB3002 study report pdf\NAIB3002supporting tables 1.pdf

 

 

NAIB3002 study report pdf\NAIB3002supporting tables 2.pdf

 

 

Relenza treatment submission full document.pdf

16, 16, 17, 17, 18, 19, 27, 30, 31, 63, 63, 63, 76, 117, 117, 117, 118, 118, 120, 120, 122, 122, 124, 124, 125, 125, 127, 127, 144

 

Relenza treatment submission main text.pdf

16, 16, 17, 17, 18, 19, 27, 30, 31

 

NAI30011

Relenza treatment submission full document.pdf

146

1 document with 1 instance

NAIB2007

NAI30009 study report pdf\CSR30009.pdf

95

10 documents with 379 instances

NAI30009 study report pdf\NAI 30009 HO final FSR.pdf

10

 

NAIA3002 study report pdf\NAIA3002 full study report.pdf

28, 28, 29

 

NAIA3005 study report pdf\A3005cr01.pdf

25

 

NAIB2007 study report pdf\b2007cr.pdf

 

 

NAIB2007 study report pdf\TABLES.pdf

 

 

NAIB3001 study report pdf\NAIB3001 full study report.pdf

25.26

 

NAIB3002 study report pdf\NAIB3002 full study report.pdf

28, 28, 29

 

Relenza treatment submission full document.pdf

16, 16, 17, 18, 18, 19, 27, 30, 31, 76, 91, 91, 92, 92, 94, 94, 96, 96, 98, 98, 144

 

Relenza treatment submission main text.pdf

16, 16, 17, 18, 18, 19, 27, 30, 31

 

NAIA2006

NAIA2005 study report pdf\a2005cr.pdf

38, 73, 74

4 documents with 6 instances

NAIA3002 study report pdf\NAIA3002 full study report.pdf

28

 

NAIA3005 study report pdf\A3005cr01.pdf

25

 

NAIB3002 study report pdf\NAIB3002 full study report.pdf

28

 

NAIB2006

NAIA3002 study report pdf\NAIA3002 full study report.pdf

28

3 documents with 3 instances

NAIA3005 study report pdf\A3005cr01.pdf

25

 

NAIB3002 study report pdf\NAIB3002 full study report.pdf

28

 

NAIB1007

 

 

 

C94‐009

 

 

 

C94‐085

 

 

 

NAIB1001

 

 

 

NAIB_1001

 

 

 

NAIA2005

 

 

 

 

 

 

 

 

 

 

 

NAI30009 study report pdf\CSR30009.pdf

95

12 documents with 895 instances

NAIA2005 study report pdf\a2005cr.pdf

 

 

NAIA2005 study report pdf\APPS_ALL.pdf

 

 

NAIA2005 study report pdf\TBS_ALL.pdf

 

 

NAIA3002 study report pdf\NAIA3002 full study report.pdf

28, 28, 48, 48

 

NAIA3005 study report pdf\A3005cr01.pdf

25

 

NAIB2005 study report pdf\b2005cr.pdf

7, 7, 22, 25, 26, 34, 34, 42, 71, 72, 72

 

NAIB2007 study report pdf\b2007cr.pdf

76

 

NAIB3001 study report pdf\NAIB3001 full study report.pdf

25

 

NAIB3002 study report pdf\NAIB3002 full study report.pdf

28, 28, 47, 47

 

Relenza treatment submission full document.pdf

16, 16, 16, 16, 17, 18, 27, 30, 76, 77, 77, 77, 79, 79, 79, 80, 80, 82, 82, 84, 84, 85, 144, 144

 

Relenza treatment submission main text.pdf

16, 16, 16, 16, 17, 18, 27, 30

 

NAIB2005

 

 

 

 

 

 

 

 

 

 

 

NAI30009 study report pdf\CSR30009.pdf

95

12 documents with 838 instances

NAIA2005 study report pdf\a2005cr.pdf

7, 8, 8, 24, 24, 25, 43, 70, 74, 74

 

NAIA3002 study report pdf\NAIA3002 full study report.pdf

28, 28, 48, 48

 

NAIA3005 study report pdf\A3005cr01.pdf

25

 

NAIB2005 study report pdf\APPSNEW.pdf

 

 

NAIB2005 study report pdf\b2005cr.pdf

 

 

NAIB2005 study report pdf\TBS_ALL.pdf

 

 

NAIB2007 study report pdf\b2007cr.pdf

76

 

NAIB3001 study report pdf\NAIB3001 full study report.pdf

25

 

NAIB3002 study report pdf\NAIB3002 full study report.pdf

28, 28, 47, 47

 

Relenza treatment submission full document.pdf

16, 16, 16, 16, 17, 18, 27, 30, 76, 77, 79, 79, 85, 85, 85, 86, 86, 88, 88, 90, 90, 144, 144

 

Relenza treatment submission main text.pdf

16, 16, 16, 16, 17, 18, 27, 30

 

NAIA/B2008

 

 

 

 

 

NAI30009 study report pdf\CSR30009.pdf

95

6 documents with 16 instances

NAI30009 study report pdf\NAI 30009 HO final FSR.pdf

10

 

NAIA3002 study report pdf\NAIA3002 full study report.pdf

28, 28, 29, 29

 

NAIA3005 study report pdf\A3005cr01.pdf

25

 

NAIB3001 study report pdf\NAIB3001 full study report.pdf

25, 26, 26, 26, 77

 

NAIB3002 study report pdf\NAIB3002 full study report.pdf

28, 28, 29, 29

 

NAIA2010

NAIA3005 study report pdf\A3005cr01.pdf

25

1 document with 1 instance

NAIA/B2009

NAIA3002 study report pdf\NAIA3002 full study report.pdf

28

3 documents with 3 instances

NAIA3005 study report pdf\A3005cr01.pdf

25

 

NAIB3002 study report pdf\NAIB3002 full study report.pdf

28

 

167‐02

 

 

 

167‐03

 

 

 

167‐05

 

 

 

167‐04

 

 

 

JNAI‐03

 

 

 

JNAI‐02

 

 

 

JNAI‐01

 

 

 

JNAI‐07

 

 

 

JNAI‐04

 

 

 

PE‐01

 

 

 

167‐101

 

 

 

167T3‐11 

 

 

 

Zanamivir trials citation by trial ID and source NICE file. Page numbers separated by commas (where applicable) indicate which trial is cited where in which file. Blank spaces indicate no citation for known trials

Figuras y tablas -
Table 4. Table of contents for studies of zanamivir described in regulatory documentation from NICE (UK)
Table 5. Table of contents for studies of oseltamivir described in regulatory documentation from NICE (UK)

Referenced study

File name volume*

Pages where study is mentioned (separated by commas)

Note

133312

 

 

 

GS97‐802

 

 

 

133312

 

 

 

GS‐97‐801

 

 

 

JP15734

 

 

 

JP15735

 

 

 

JV15823

 

 

 

JV15824

 

 

 

JV16284

 

 

 

M76001

1

33, 36, 37, 37, 38, 38, 39, 67, 68, 94, 95, 224

1 document with 12 instances

M76006

 

 

 

ML20910

 

 

 

ML22789

 

 

 

ML22879

 

 

 

MV21118

 

 

 

MV22841

 

 

 

NCT00298233

 

 

 

NCT00555893

 

 

 

NCT00707941

 

 

 

NCT00799760

 

 

 

NCT00830323

 

 

 

ML25018

 

 

 

NCT00867139

 

 

 

NCT00873886

 

 

 

NCT01002729

 

 

 

NP15717

6

32, 75, 76, 77

2 documents with 5 instances

8

68

 

6

73.98

1 document with 2 instances

NP15718

 

 

 

NP15728

 

 

 

NP15757

8

68

1 document with 1 instance

NP15826

6

32, 75, 75, 75, 76, 76, 77, 78, 79, 80, 98

1 document with 11 instances

NP15827

8

68

1 document with 1 instance

NP22770

 

 

 

NP25138

 

 

 

NP25139

 

 

 

NV16871

 

 

 

NV20234

 

 

 

NV20235 

 

 

 

NV20236

 

 

 

NV20237

 

 

 

NV22155

 

 

 

NV25118

 

 

 

NV25182

 

 

 

PP16351

 

 

 

WP15517

1

185.245

1 document with 2 instances

WP15525

1

185.245

1 document with 2 instances

WP15647

 

 

 

WP15648

 

 

 

WP15676

 

 

 

WP15901

 

 

 

WP22849

 

 

 

WV144181

 

 

 

WV15670

1

33, 36, 37, 37, 38, 38, 39, 47, 48, 48, 49, 49, 50, 53, 54, 54, 55, 163, 171, 188, 207, 209, 224, 245, 245, 252, 253, 253

7 documents with 1193 instances

10

7, 36, 37, 37

 

2

 

 

3

 

 

4

90

 

6

35.98

 

8

65

 

2

20, 20, 20, 20, 20

1 document with 5 instances

WV15671

 

1

33, 36, 37, 37, 38, 38, 39, 47, 48, 49, 49, 50, 53, 54, 54, 55, 163, 171, 188, 207, 209, 224, 245, 245

7 documents with 1222 instances

10

7, 36, 37, 37

 

2

82

 

4

 

 

5

 

 

6

35.98

 

8

66

 

WV15673

8

66

1 document with 1 instance

WV15673D

8

66

1 document with 1 instance

WV15697

8

 

1 document with 1 instance

WV15697D

8

 

1 document with 1 instance

WV15707

1

33, 36, 37, 37, 38, 67, 68, 224, 245, 245, 245, 246

1 document with 12 instances

WV15708

 

 

 

WV15708D

 

 

 

WV15730

1

33, 36, 37, 37, 38, 38, 39, 47, 53, 54, 55, 186, 207, 224, 245, 245, 246

4 documents with 22 instances

10

7, 36, 37

 

2

82

 

4

90

 

WV15731

6

98

1 document with 1 instance

WV15758

1

36, 37, 82, 83, 84, 85, 86, 92, 94, 95, 97, 106, 224, 246

4 documents with 424 instances

6

 

 

7

 

 

8

68

 

WV15759

1

36, 37, 94, 95, 95, 109, 113, 114, 121, 122, 224, 246

1 document with 12 instances

WV15799

1

137, 139, 139, 232, 233

3 documents with 499 instances

8

 

 

9

 

 

WV15812

1

36, 37, 37, 38, 38, 39, 67, 68, 68, 107, 107, 107, 108, 108, 121, 121, 122, 123, 224, 246

2 documents with 197 instances

10

 

 

WV15819

1

33, 36, 37, 37, 38, 58, 58, 59, 59, 60, 61, 62, 62, 65, 65, 67, 68, 224, 246

2 documents with 173 instances

10

 

 

WV15825

8

66, 66

1 document with 2 instances

WV15871

1

109, 246

1 document with 2 instances

WV15872

1

36, 37, 37, 38, 38, 39, 67, 68, 68, 107, 107, 108, 108, 121, 121, 122, 123, 224

1 document with 18 instances

WV15876

1

246, 246

1 document with 2 instances

WV15978

1

67, 70, 175, 246, 246

1 document with 5 instances

WV16193

 

 

 

ML16369

 

 

 

Oseltamivir trials citation by trial ID and source NICE file. Page numbers separated by commas (where applicable) indicate which trial is cited where in which file. Blank spaces indicate no citation for known trials.

All the studies have been searched in the folder "Roche submission".

When there is the number of the volume but no pages are mentioned, it means that the code of the study is cited more than 100 times.

*Number of the volume of the Tamiflu NICE submission.

Figuras y tablas -
Table 5. Table of contents for studies of oseltamivir described in regulatory documentation from NICE (UK)
Table 6. Time to alleviation* of clinically significant symptoms of influenza‐like illness (in all participants and participants with no use of relief medication)

Study

Sample size

Median days to alleviation for all participants

Difference in days

(P value)

Median days to alleviation and no use of relief medication

Difference in days (P value)

Zanamivir (n)

Placebo (n)

Zanamivir

Placebo

Zanamivir

Placebo

NAI30008

262

263

6.0

7.0

1.0

(0.123)

8.0

10.0

2.0

(0.037)

NAI30009

224

247

4.5

5.0

0.5

(0.011)

5.0

6.0

1.0

(0.002)

NAI30010

76

81

4.5

5.5

1.0

(0.033)

5.5

6.75

1.25

(0.150)

NAI30011

237

229

4.50

5.00

0.50

(0.495)

7.0

7.0

0.0

(0.623)

NAI30012

191

167

6.5

7.5

1.0

(0.159)

9.0

10.0

1.0

(0.131)

NAI30015

293

295

2.17

2.67

0.5

(0.166)

3.17

3.83

0.66

(0.058)

NAIA3002

412

365

5.5

6.0

0.5

(0.228)

7.0

8.0

1.0

(0.054)

NAIB3002

174

182

5.0

7.5

2.5

(< 0.001)

5.5

8.25

2.75 (< 0.001)

*Alleviation defined as no fever (temperature < 37.8 °C), cough recorded as none or mild and muscle/joint aches and pains, sore throat, feverishness/chills and headache recorded as absent/minimal

Figuras y tablas -
Table 6. Time to alleviation* of clinically significant symptoms of influenza‐like illness (in all participants and participants with no use of relief medication)
Table 7. Oseltamivir versus placebo for treating influenza in healthy adults

Oseltamivir versus placebo for treating influenza in healthy adults

Patient or population: healthy adults with influenza
Settings: community, nursing homes
Intervention: oseltamivir versus placebo for treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Risk difference (95% CI)

NNTB or NNTH (95% CI)

Assumed risk

Corresponding risk

Placebo

Oseltamivir versus placebo for treatment

Time to first alleviation of symptoms in adult treatment (ITT population) (hours)

The mean time (hours) to first alleviation of symptoms adults in the intervention groups was
16.76 lower
(25.1 to 8.42 lower)

16.8 hours (8.4 to 25.1)

3954
(8)

N/A

N/A

Adverse events: nausea in adult treatment (on‐treatment)

Study population

RR 1.57
(1.14 to 2.15)

4452
(8)

‐3.66% (‐7.39 to ‐0.9)

NNTH = 28 (14 to 112)

64 per 1000

101 per 1000
(73 to 138)

Adverse events: vomiting in adult treatment (on‐treatment)

Study population

RR 2.43
(1.75 to 3.38)

4452
(8)

‐4.56% (‐7.58 to ‐2.39)

NNTH = 22 (14 to 42)

32 per 1000

77 per 1000
(56 to 108)

Adverse events: diarrhoea in adult treatment (on‐treatment)

Study population

RR 0.67
(0.46 to 0.98)

4452
(8)

2.33% (0.14 to 3.81)

NNTB = 43 (27 to 709)

71 per 1000

47 per 1000
(32 to 69)

Complications: self reported, investigator‐mediated, unverified pneumonia in adult treatment

Study population

RR 0.55
(0.33 to 0.90)

4452
(8)

1.00% (0.22 to 1.49)

NNTB = 100 (67 to 451)

22 per 1000

12 per 1000

(7 to 20)

Adverse events: cardiac body system in adult treatment (on‐treatment)

Study population

RR 0.49
(0.25 to 0.97)

3943
(6)

0.68% (0.04 to 1.00)

NNTB = 148 (101 to 2509)

13 per 1000

7 per 1000
(3 to 13)

Adverse events: hospital admission in adult treatment

Study population

RR 0.92

(0.57 to 1.50)

4394

(7)

0.15% (‐0.78 to 0.91)

NNTB = 687 (NNTB 110 to ∞ to NNTH 128)

18 per 1000

17 per 1000

(11 to 28)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Negative risk differences indicate harms; positive risk differences indicate benefits.
CI: confidence interval; RR: risk ratio; NNTB: number needed to treat to benefit; NNTH: number needed to treat to harm

Figuras y tablas -
Table 7. Oseltamivir versus placebo for treating influenza in healthy adults
Table 8. Oseltamivir versus placebo for treating influenza in healthy children

Oseltamivir versus placebo for treating influenza in healthy children

Patient or population: healthy children with influenza
Settings: community
Intervention: oseltamivir versus placebo for treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Risk difference (95% CI)

Comments

Assumed risk

Corresponding risk

Placebo

Oseltamivir versus placebo for treatment

Time to first alleviation of symptoms in child treatment (hours)

The mean time (hours) to first alleviation of symptoms in children in the intervention groups was
8.04 lower
(33.34 lower to 17.26 higher)

1329
(3)

Not significant

Hospital admission in child treatment (safety population)

Study population

RR 1.92
(0.7 to 5.23)

1359
(3)

‐0.81% (‐3.72 to 0.26)

NNTH = 124 (NNTB 379 to ∞ to NNTH 27)

9 per 1000

17 per 1000
(6 to 46)

Complications: bronchitis in child treatment

Study population

RR 0.65
(0.27 to 1.55)

1359
(3)

1.08% (‐1.69 to 2.25)

NNTB = 93 (NNTB 45 to ∞ to NNTH 59)

31 per 1000

20 per 1000
(8 to 48)

Complications: otitis media in child treatment

Study population

RR 0.8
(0.62 to 1.02)

1359
(3)

3.26% (‐0.33 to 6.18)

NNTB = 31 (NNTB 17 to ∞ to NNTH 308)

163 per 1000

130 per 1000
(101 to 166)

Complications: pneumonia in child treatment

Study population

RR 1.06
(0.62 to 1.83)

1359
(3)

‐0.22% (‐3.07 to 1.41)

NNTH = 450 (NNTB 71 to ∞ to NNTH 33)

37 per 1000

39 per 1000
(23 to 68)

Adverse events: diarrhoea in child treatment (on‐treatment)

Study population

RR 0.87
(0.58 to 1.28)

1358
(3)

0.93% (‐2.01 to 3.02)

NNTB 108 (NNTB 34 to ∞ to NNTH 50)

72 per 1000

63 per 1000
(42 to 92)

Adverse events: vomiting in child treatment (on‐treatment)

Study population

RR 1.7
(1.23 to 2.35)

1358
(3)

5.34% (1.75 to 10.29)

NNTH = 19 (10 to 57)

76 per 1000

130 per 1000
(94 to 179)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Negative risk differences indicate harm; positive risk differences indicate benefits.
CI: confidence interval; RR: risk ratio; NNTB: number needed to treat to benefit; NNTH: number needed to treat to harm

Figuras y tablas -
Table 8. Oseltamivir versus placebo for treating influenza in healthy children
Table 9. Zanamivir versus placebo for treating influenza in healthy adults

Zanamivir versus placebo for treating influenza in healthy adults

Patient or population: healthy adults with influenza
Settings: community, nursing homes
Intervention: zanamivir versus placebo for treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Risk difference (95% CI)

NNTB or NNTH (95% CI)

Assumed risk

Corresponding risk

Placebo

Zanamivir versus placebo for treatment

Time to first alleviation of symptoms in adult treatment (days)

The mean time (days) to first alleviation of symptoms in adults in the intervention groups was
0.60 lower
(0.81 to 0.39 lower)

0.60 days (0.39 to 0.81)

5411
(13)

N/A

N/A

Complications: pneumonia confirmed with X‐ray in adult treatment

Study population

RR 1.02
(0.35 to 3.02)

946
(2)

‐0.06% (‐6.56 to 2.11)

NNTH = 1540 (NNTB 48 to ∞ to NNTH 16)

32 per 1000

33 per 1000
(11 to 98)

Adverse events: nausea/vomiting in adult treatment (on‐treatment)

Study population

RR 0.6
(0.39 to 0.94)

6553
(15)

1.63% (0.24 to 2.48)

NNTB = 62 (41 to 411)

41 per 1000

24 per 1000
(16 to 38)

Adverse events: psychiatric body system in adult treatment (on‐treatment)

Study population

RR 1.16
(0.57 to 2.38)

4732
(10)

‐0.09% (‐0.76 to 0.24)

NNTH 1132 (NNTB 421 to ∞ to NNTH 132)

6 per 1000

6 per 1000
(3 to 13)

Complications: bronchitis in adult treatment

Study population

RR 0.75

(0.61 to 0.91)

6072

(12)

1.80% (0.65 to 2.80)

NNTB 56 (36 to 155)

72 per 1000

54 per 1000

(44 to 65)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Negative risk differences indicate harms; positive risk differences indicate benefits.
CI: confidence interval; RR: risk ratio; NNTB: number needed to treat to benefit; NNTH: number needed to treat to harm

Figuras y tablas -
Table 9. Zanamivir versus placebo for treating influenza in healthy adults
Table 10. Zanamivir versus placebo for treating influenza in healthy children

Zanamivir versus placebo for treating influenza in healthy children

Patient or population: healthy children with influenza
Settings: community
Intervention: zanamivir versus placebo for treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Risk difference (95% CI)

NNTB or NNTH (95% CI)

Assumed risk

Corresponding risk

Placebo

Zanamivir versus placebo for treatment

Time to first alleviation of symptoms in children (days)

The mean time (days) to first alleviation of symptoms in children in the intervention groups was
1.08 lower
(2.32 lower to 0.15 higher)

723
(2)

NA

NA

Complications: sinusitis in child treatment

Study population

RR 0.87
(0.12 to 6.45)

737
(2)

0.19% (‐8.09 to 1.31)

NNTB = 519 (NNTB 13 to ∞ to NNTH 77)

15 per 1000

13 per 1000
(2 to 96)

Complications: otitis media in child treatment

Study population

RR 1.0
(0.59 to 1.72)

737
(2)

0.00% (‐5.13 to 2.92)

NNTB = > 1000 (NNTB 35 to ∞ to NNTH 20)

71 per 1000

71 per 1000
(42 to 122)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Negative risk differences indicate harms; positive risk differences indicate benefits.
CI: confidence interval; RR: risk ratio; NNTB: number needed to treat to benefit; NNTH: number needed to treat to harm

Figuras y tablas -
Table 10. Zanamivir versus placebo for treating influenza in healthy children
Table 11. Oseltamivir versus placebo for preventing influenza in healthy children

Oseltamivir versus placebo for preventing influenza in healthy children

Patient or population: healthy children without influenza
Settings: community
Intervention: oseltamivir versus placebo for prophylaxis

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Comments

Assumed risk

Corresponding risk

Placebo

Oseltamivir versus placebo for treatment

No data

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio

Figuras y tablas -
Table 11. Oseltamivir versus placebo for preventing influenza in healthy children
Table 12. Zanamivir versus placebo for preventing influenza in healthy adults

Zanamivir versus placebo for preventing influenza in healthy adults

Patient or population: healthy adults without influenza
Settings: community, nursing homes
Intervention: zanamivir versus placebo for prophylaxis

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Risk difference (95% CI)

NNTB or NNTH (95% CI)

Assumed risk

Corresponding risk

Placebo

Zanamivir versus placebo for prophylaxis

Symptomatic influenza in prophylaxis of individuals

Study population

RR 0.39

(0.22 to 0.70)

5275

(4)

1.98% (0.98 to 2.54)

NNTB = 51 (40 to 103)

33 per 1000

13 per 1000
(7 to 23)

Asymptomatic influenza in prophylaxis of individuals

Study population

RR 0.97
(0.76 to 1.24)

5275
(4)

0.14% (‐1.1 to 1.1)

NNTB = 729 (NNTB 91 to ∞ to NNTH 91)

50 per 1000

48 per 1000
(38 to 60)

Symptomatic influenza in household prophylaxis

Study population

RR 0.22
(0.13 to 0.36)

824
(2)

14.84% (12.18 to 16.55)

NNTB = 7 (6 to 9)

190 per 1000

42 per 1000
(25 to 68)

Asymptomatic influenza in household prophylaxis

Study population

RR 0.90
(0.6 to 1.35)

824
(2)

1.32% (‐2.2 to 3.84)

NNTB = 76 (NNTB 26 to ∞ to NNTH 46)

107 per 1000

97 per 1000
(64 to 145)

Complications: pneumonia in adult prophylaxis

Study population

RR 0.30
(0.11 to 0.8)

7662
(6)

0.32% (0.09 to 0.41)

NNTB = 311 (244 to 1086)

5 per 1000

1.5 per 1000
(1 to 4)

Complications: bronchitis in adult prophylaxis

Study population

RR 0.49

(0.02 to 1.19)

7662

(6)

0.79% (‐0.29 to 1.24)

NNTB = 127 (to NNTB 81 to ∞ to NNTH 341)

15 per 1000

8 per 1000

(3 to 18)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Negative risk differences indicate harms; positive risk differences indicate benefits.
CI: confidence interval; RR: risk ratio; NNTB: number needed to treat to benefit; NNTH: number needed to treat to harm

Figuras y tablas -
Table 12. Zanamivir versus placebo for preventing influenza in healthy adults
Table 13. Oseltamivir versus placebo for preventing influenza in healthy adults

Oseltamivir versus placebo for preventing influenza in healthy adults

Patient or population: healthy adults without influenza
Settings: community, nursing homes
Intervention: oseltamivir for prophylaxis
Comparison: placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Risk difference (95% CI)

NNTB or NNTH (95% CI)

Assumed risk

Corresponding risk

Placebo

Oseltamivir versus placebo for prophylaxis

Symptomatic influenza in adult prophylaxis of individuals

Study population

RR 0.45
(0.30 to 0.67)

2479
(3)

3.05% (1.83 to 3.88)

NNTB = 33 (26 to 55)

55 per 1000

25 per 1000
(17 to 37)

Symptomatic influenza in household prophylaxis

Study population

RR 0.2
(0.09 to 0.44)

405
(1)

13.6% (9.52 to 15.47)

NNTB = 7 (6 to 11)

170 per 1000

34 per 1000
(15 to 75)

Adverse events: psychiatric body systems in adult prophylaxis (all events on‐ and off‐treatment)

Study population

RR 1.80
(1.05 to 3.08)

3434
(4 studies)

‐1.06% (‐2.76 to ‐0.07)

NNTH = 94 (36 to 1538)

13 per 1000

23 per 1000
(14 to 40)

Adverse events: headache in adult prophylaxis (on‐treatment)

Study population

RR 1.18
(1.05 to 1.33)

3434
(4)

‐3.15% (‐5.78 to ‐0.88)

NNTH = 32 (18 to 115)

175 per 1000

207 per 1000
(184 to 233)

Adverse events: nausea in adult prophylaxis (on‐treatment)

Study population

RR 1.96
(1.2 to 3.2)

3434
(4)

‐4.15% (‐9.51 to ‐0.86)

NNTH = 25 (11 to 116)

43 per 1000

85 per 1000
(52 to 138)

Adverse events: vomiting in adult prophylaxis (on‐treatment)

Study population

RR 1.91
(0.7 to 5.22)

3434
(4)

‐0.95% (‐4.41 to 0.31)

NNTH = 106 (NNTB 319 to ∞ to NNTH 23)

10 per 1000

20 per 1000
(7 to 55)

Adverse events: headache in adult prophylaxis (off‐treatment)

Study population

RR 0.88
(0.63 to 1.24)

3434
(4)

0.44% (‐0.89 to 1.37)

NNTB = 226 (NNTB 74 to ∞ to NNTH 113)

37 per 1000

33 per 1000
(23 to 46)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Negative risk differences indicate harms; positive risk differences indicate benefits.
CI: confidence interval; RR: risk ratio; NNTB: number needed to treat to benefit; NNTH: number needed to treat to harm

Figuras y tablas -
Table 13. Oseltamivir versus placebo for preventing influenza in healthy adults
Table 14. Zanamivir versus placebo for preventing influenza in healthy children

Zanamivir versus placebo for preventing influenza in healthy children

Patient or population: healthy children without influenza
Settings: community
Intervention: zanamivir versus placebo for prophylaxis

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Comments

Assumed risk

Corresponding risk

Placebo

Zanamivir versus placebo for treatment

No data

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio

Figuras y tablas -
Table 14. Zanamivir versus placebo for preventing influenza in healthy children
Table 15. Psychiatric adverse events in oseltamivir prophylaxis trials

Oseltamivir

Placebo

Total

Event type

# Events

%

# Events

%

# Events

%

Confusion

5

0.25

1

0.07

6

0.17

Depression

14

0.7

6

0.42

20

0.58

Hallucinations

2

0.1

0

0.00

2

0.06

Anxiety

7

0.35

8

0.56

15

0.44

Psychosis

2

0.1

1

0.07

3

0.09

Schizophrenia

1

0.05

0

0.00

1

0.03

Bipolar disorder

0

0

1

0.07

1

0.03

Sleeping disorder

2

0.1

0

0.00

2

0.06

Aggression

1

0.05

0

0.00

1

0.03

Stress symptoms

3

0.15

0

0.00

3

0.09

Restlessness

1

0.05

0

0.00

1

0.03

Nervousness

1

0.05

0

0.00

1

0.03

Suicide ideation

1

0.05

0

0.00

1

0.03

Paranoia

1

0.05

0

0.00

1

0.03

Alcohol related

6

0.3

2

0.14

8

0.23

Total

47

2.35

19

1.32

66

1.92

Of the 66 events, 12 were classified as severe intensity (10 oseltamivir, 2 placebo)

Figuras y tablas -
Table 15. Psychiatric adverse events in oseltamivir prophylaxis trials
Table 16. Proportions of contacts with positive serology data (WV15799 ITTIINAB population)

Positive

serology

Group

Total

Placebo

N

%

Tamiflu

N

%

No

166
83.0

192
93.7

358
 

Yes

34
17.0

13
6.3

47
 

Total

200

205

405

ITTIINAB population: ITT influenza‐infected index cases who had negative virology at baseline

Chi² P = 0.001

Figuras y tablas -
Table 16. Proportions of contacts with positive serology data (WV15799 ITTIINAB population)
Table 17. Oseltamivir and placebo intervention contents by trial

Trial ID

Description oseltamivir/batch no.

Description placebo/batch no.

Certified content

(oseltamivir)

Certified content

(placebo)

Ref (PDF page number)

M76001

Size 2 capsules containing 75 mg oseltamivir/V01‐00 (GS 4104), batch number GMZ 0082

Size 2 placebo capsules for oseltamivir/V02‐00 (GS 4104), batch number GMZ 0083

Unknown (certificate of analysis not provided)

Unknown (certificate of analysis not provided)

20

WP16263

Grey opaque body, light yellow opaque cap/PT2247C01

Grey opaque body, ivory opaque cap/GMZ 0163

 

Oseltamivir 97.5 mg

Dehydrocholic acid

19 and 422

WV15670

Size 2 capsules containing 75 mg Ro 64‐0796/V01‐00 (GS 4104), batch number GMZ 0067; caramel opaque body, caramel opaque cap

Size 2 placebo capsules for Ro 64‐0796/V02‐00 (GS 4104), batch number GMZ 0066; caramel opaque body, caramel opaque cap

Oseltamivir 94.3 mg

Dehydrocholic acid 6.13 mg

13, 834‐5

WV15671

Capsules (size 2) containing 75 mg Ro 64‐0796 (GS 4104)/V01; batch number GMZ 0067/GMZ 0065. Capsules are caramel opaque body, caramel opaque cap. Also used batch GMZ 0067 capsules caramel opaque body, caramel opaque cap (for oseltamivir 94.3 mg)

Matching placebo capsules (size 2) for Ro 64‐0796 (GS  4104)/V02; batch number GMZ 0066. Capsules are caramel opaque body, caramel opaque cap

Oseltamivir 93.1 mg and oseltamivir 94.3 mg

Dehydrocholic acid 6.13 mg

13, 764‐7

WV15673/WV15697

GS 4104 (Ro 64‐0796) provided as size 2 caramel‐coloured capsules containing 75 mg of active drug and packaging material consisting of dehydrocholic acid, dibasic calcium phosphate dihydrate, pregelatinised starch, povidone, talc and sodium stearyl fumarate." Ro 64‐0796/V01‐00 batch GMZ 0067; caramel opaque body, caramel opaque cap

Placebo provided as size 2 caramel‐coloured capsules, containing dehydrocholic acid, dibasic calcium phosphate dihydrate, pregelatinised starch, povidone, talc and sodium stearyl fumarate Ro64‐0796/V02‐00 batch GMZ 0066; caramel opaque body, caramel opaque cap

94.3 mg

Dehydrocholic acid 6.13 mg

385, 540‐2

WV15707

Ro 64‐0796 was provided as a size 2 capsule containing 75 mg of active drug and packaging material consisting of pregelatinised starch, povidone, talc and sodium stearyl fumarate. Ro 64‐0796 (GS4104)/V01‐00 batch number GMZ 0082

Placebo was provided as a size 2 capsule containing dehydrocholic acid, dibasic calcium phosphate dihydrate and packaging material consisting of pregelatinised starch, povidone, talc and sodium stearyl fumarate. Placebo Ro 64‐0796/V02‐00 batch number GMZ 0066

Ro 64‐0796/002 100.5 mg

Dehydrocholic acid

3, 517‐9

WV15708

Size 2 capsules of 75 mg; Ro 64‐0796/V01‐00 batch no. GMZ 0082; caramel opaque body, caramel opaque cap

Matching size 2 placebo capsules Ro 64‐0796/V02‐00 batch no. GMZ 0083; caramel opaque body, caramel opaque cap

Oseltamivir 100.5 mg

Dehydrocholic acid

21‐2, 517‐9

WV15730

Ro  64‐0796 was provided as a caramel, opaque, size 2 capsule containing 75 mg of active drug and packaging material consisting of pregelatinised starch, povidone, talc and sodium stearyl fumarate. Ro 64‐0796 (GS4104)/V01‐00 batch number GMZ 0082

Placebo was provided as a caramel, opaque, size 2 capsule containing dehydrocholic acid, dibasic (calcium phosphate dihydrate and packaging material consisting of  pregelatinised starch, povidone, talc and sodium  stearyl fumarate. Placebo Ro  64‐0796/V02‐00 batch number GMZ 0083

Oseltamivir 100.5 mg

Dehydrocholic acid

24, 504‐5

WV15758

2 batches of the paediatric formulation were used in the present study:

1. Ro 64‐0796/V20‐01 (0.6% syrup); batch no. G HK 0180/05

2. Ro 64‐0796/V20‐01 (0.6% syrup); batch no. G HK 0180/06

2 batches of the corresponding placebo formulation were used:

1. Ro 64‐0796/V19‐01; batch no. G HK 0179/04

2. Ro 64‐0796/V19‐01; batch no. G HK 0179/05

Oseltamivir 0.768 g (G HK 0180/05), 0.763 g (G HK 0180/06)

Dehydrocholic acid

27, 1043‐5

WV15759/15871

Ro 64‐0796 was to be provided as a dry powder for reconstitution with water. The powdered formulation contains the active ingredient, sorbitol and saccharin sodium (sweeteners), betacarotene (colouring agent), permageal 31 tutti frutti (flavour), cellulose, xanthan gum and methylhydroxy/propylhydroxybenzoate

Unknown (certificates of analysis not in our possession)

Unknown (certificates of analysis not in our possession)

36

WV15799

Ro 64‐0796 was provided as ivory, opaque, size 2 capsule containing 75 mg of active drug and packaging material consisting of pregelatinised starch, povidone, talc and sodium stearyl fumarate. Ro 64‐0796 (GS4104)/V14‐00 batch numbers GMZ 0124/03 and GMZ 0129/03

Placebo was provided as an ivory, opaque, size 2 capsule containing dehydrocholic acid, dibasic calcium phosphate dihydrate and packaging material consisting of pregelatinised starch, povidone, talc and sodium stearyl fumarate. Placebo Ro 64‐0796/V16‐00 batch number GMZ 0136

Unknown (certificates of analysis not in our possession)

Unknown (certificates of analysis not in our possession)

24

WV15812/WV15872

Ro 64‐0976 was provided as size 2 capsules containing 75 mg of active drug and packaging material consisting of pregelatinised starch, povidone, talc and sodium stearyl fumarate

Matching placebo was provided as size 2 capsules containing dehydrocholic acid, dibasic calcium phosphate dihydrate, pregelatinised starch, povidone, talc, sodium stearyl fumarate

Unknown (certificate of analysis not provided)

Unknown (certificate of analysis not provided)

18

WV15876/WV15819/WV15978

Capsules (size 2) containing 95.8 mg oseltamivir phosphate, equivalent to 75 mg oseltamivir: formulation V14; batch numbers GMZ 0124/03, GMZ 0129/03. Both batches: grey opaque body, ivory opaque cap

The following statement appears after the description of the placebo; whether it applies to oseltamivir capsules is unclear: "Excipients for each capsule consisted of dehydrocholic acid, dibasic calcium diphosphate dihydrate, pregelatinized starch, povidone, talc, sodium stearyl fumarate."

Matching placebo capsules (size 2) for oseltamivir: formulation V16; batch numbers GMZ 0136, GMZ 0163. Both batches: grey opaque body, ivory opaque cap

The following statement appears after the description of the placebo; whether it applies to oseltamivir capsules is unclear: "Excipients for each capsule consisted of dehydrocholic acid, dibasic calcium diphosphate dihydrate, pregelatinized starch, povidone, talc, sodium stearyl fumarate."

Oseltamivir 95.7 mg (GMZ 0124/03); 97.9 mg (GMZ 0129/03)

Dehydrocholic acid

21, 944‐9

WV16277

Oseltamivir was provided as size 2 capsules containing 75 mg of active drug and packaging material consisting of pregelatinised starch, povidone, talc and sodium stearyl fumarate.. Oseltamivir: 75 mg capsules, Ro 64‐0796/V14, batch number PT2247C01

Capsules are caramel opaque body, caramel opaque cap

Matching placebo was provided as size 2 capsules, containing dehydrocholic acid, dibasic calcium phosphate dihydrate, pregelatinised starch, povidone, talc, sodium stearyl fumarate Matching placebo capsules: Ro 64‐0796/V16, batch number GMZ 0163. Capsules are caramel opaque body, caramel opaque cap

Unknown (certificate of analysis not provided)

Unknown (certificate of analysis not provided)

20

NV16871

Capsules containing 75 mg of active drug and packaging material consisting of pregelatinised starch, povidone, talc and sodium stearyl fumarate. All participants over the age of 13 or who weighed > 40 kg received this dosage form. 2. A paediatric suspension containing 12 mg oseltamivir per ml of reconstituted solution and the following excipients: sorbitol, titanium dioxide, sodium benzoate, xanthan gum, monosodium citrate, saccharin sodium and Permaseal 11900‐31 tutti frutti (flavour). All participants of 12 years and under or who weighed ≤ 40 kg received this dosage form or 10 doses

Ro 64‐0796/V14 (oseltamivir 75 mg capsules), batch PT2247C01

Ro 64‐0796/V37 (oseltamivir powder for oral suspension), batch B1023

Matching placebo was to be provided as capsules and as suspension

Ro 64‐0796/V16 (placebo capsules), batch GMZ 0163

Ro 64‐0796/VF01 (placebo powder for oral suspension), batch C0318A001

Unknown (certificate of analysis not provided)

Unknown (certificate of analysis not provided)

13‐14, 24

NB Most content dosage unavailable at review time‐lock.

Figuras y tablas -
Table 17. Oseltamivir and placebo intervention contents by trial
Comparison 1. Oseltamivir versus placebo for treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Time to first alleviation of symptoms in adult treatment (ITT population) Show forest plot

8

3954

Mean Difference (IV, Random, 95% CI)

‐16.76 [‐25.10, ‐8.42]

2 Hospital admission in adult treatment (safety population) Show forest plot

7

4394

Risk Ratio (IV, Random, 95% CI)

0.92 [0.57, 1.50]

3 Defined as influenza‐infected at baseline in adult treatment Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.95 [0.91, 0.99]

4 Antibody rise four‐fold or greater in adult treatment Show forest plot

8

4025

Risk Ratio (IV, Random, 95% CI)

0.92 [0.86, 0.97]

5 Adverse events ‐ nausea in adult treatment (on‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

1.57 [1.14, 2.15]

6 Adverse events ‐ vomiting in adult treatment (on‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

2.43 [1.75, 3.38]

7 Adverse events ‐ diarrhoea in adult treatment (on‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.67 [0.46, 0.98]

8 Withdrawal from adult treatment trial due to adverse events Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.91 [0.56, 1.48]

9 All withdrawals from adult treatment Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

1.02 [0.73, 1.41]

10 Adverse events ‐ cough in adult treatment (on‐treatment) Show forest plot

6

3943

Risk Ratio (IV, Random, 95% CI)

0.63 [0.41, 0.96]

11 Adverse events ‐ abdominal pain in adult treatment (on‐treatment) Show forest plot

6

4368

Risk Ratio (IV, Random, 95% CI)

1.00 [0.64, 1.55]

12 Adverse events: dizziness in adult treatment (on‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.77 [0.51, 1.18]

13 Adverse events: headache in adult treatment (on‐treatment) Show forest plot

7

4426

Risk Ratio (IV, Random, 95% CI)

1.17 [0.72, 1.90]

14 Serious adverse events: overall in adult treatment (on‐treatment) Show forest plot

7

4394

Risk Ratio (IV, Random, 95% CI)

0.96 [0.51, 1.80]

15 Serious adverse events: overall in adult treatment (off‐treatment) Show forest plot

7

4394

Risk Ratio (IV, Random, 95% CI)

0.73 [0.39, 1.37]

16 Complications: bronchitis in adult treatment Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.75 [0.56, 1.01]

16.1 Trials which collected data on non‐specific adverse event or secondary/intercurrent illness form

6

3316

Risk Ratio (IV, Random, 95% CI)

0.66 [0.42, 1.03]

16.2 Trials which collected data on specific "Diagnosis of secondary illness" form

2

1136

Risk Ratio (IV, Random, 95% CI)

0.87 [0.61, 1.26]

17 Complications: pneumonia in adult treatment Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.55 [0.33, 0.90]

17.1 Trials which collected data on non‐specific adverse event or secondary/intercurrent illness form

6

3316

Risk Ratio (IV, Random, 95% CI)

0.44 [0.22, 0.88]

17.2 Trials which collected data on specific "Diagnosis of secondary illness" form

2

1136

Risk Ratio (IV, Random, 95% CI)

0.69 [0.33, 1.44]

18 Complications: sinusitis in adult treatment Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

1.03 [0.76, 1.40]

18.1 Trials which collected data on non‐specific adverse event or secondary/intercurrent illness form

6

3316

Risk Ratio (IV, Random, 95% CI)

1.05 [0.74, 1.50]

18.2 Trials which collected data on specific "Diagnosis of secondary illness" form

2

1136

Risk Ratio (IV, Random, 95% CI)

0.97 [0.52, 1.80]

19 Complications: otitis media in adult treatment Show forest plot

6

4368

Risk Ratio (IV, Random, 95% CI)

1.11 [0.57, 2.15]

19.1 Trials which collected data on non‐specific adverse event or secondary/intercurrent illness form

4

3232

Risk Ratio (IV, Random, 95% CI)

0.99 [0.46, 2.12]

19.2 Trials which collected data on specific "Diagnosis of secondary illness" form

2

1136

Risk Ratio (IV, Random, 95% CI)

1.57 [0.41, 6.02]

20 Complications in adult trials classified as serious or leading to study withdrawal Show forest plot

6

3675

Risk Ratio (IV, Random, 95% CI)

0.91 [0.40, 2.06]

21 Culture‐positive at baseline in adult treatment Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

1.01 [0.95, 1.07]

22 Adverse events: general body system in adult treatment (on‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.88 [0.67, 1.17]

23 Adverse events: neurological body system in adult treatment (on‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

1.05 [0.80, 1.38]

24 Adverse events: respiratory body system in adult treatment (on‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.81 [0.65, 1.00]

25 Adverse events: infection body system in adult treatment (on‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.85 [0.71, 1.01]

26 Adverse events: gastrointestinal body system in adult treatment (on‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

1.25 [1.08, 1.45]

27 Adverse events: cardiac body system in adult treatment (on‐treatment) Show forest plot

6

3943

Risk Ratio (IV, Random, 95% CI)

0.49 [0.25, 0.97]

28 Adverse events: ear body system in adult treatment (on‐treatment) Show forest plot

7

4426

Risk Ratio (IV, Random, 95% CI)

0.99 [0.61, 1.60]

29 Adverse events: eye body system in adult treatment (on‐treatment) Show forest plot

7

4426

Risk Ratio (IV, Random, 95% CI)

1.00 [0.52, 1.92]

30 Adverse events: metabolism body system in adult treatment (on‐treatment) Show forest plot

7

4394

Risk Ratio (IV, Random, 95% CI)

0.81 [0.46, 1.43]

31 Adverse events: musculoskeletal body system in adult treatment (on‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

1.01 [0.59, 1.73]

32 Adverse events: psychiatric body system in adult treatment (on‐treatment) Show forest plot

7

4426

Risk Ratio (IV, Random, 95% CI)

0.93 [0.43, 2.03]

33 Adverse events: skin body system in adult treatment (on‐treatment) Show forest plot

7

4426

Risk Ratio (IV, Random, 95% CI)

1.14 [0.63, 2.06]

34 Adverse events: cardiac body system in adult treatment (off‐treatment) Show forest plot

7

4394

Risk Ratio (IV, Random, 95% CI)

1.21 [0.55, 2.64]

35 Adverse events: ear body system in adult treatment (off‐treatment) Show forest plot

6

4368

Risk Ratio (IV, Random, 95% CI)

1.17 [0.57, 2.42]

36 Adverse events: gastrointestinal body system in adult treatment (off‐treatment) Show forest plot

7

4394

Risk Ratio (IV, Random, 95% CI)

1.08 [0.74, 1.58]

37 Adverse events: general body system in adult treatment (off‐treatment) Show forest plot

7

4394

Risk Ratio (IV, Random, 95% CI)

0.90 [0.50, 1.62]

38 Adverse events: infection body system in adult treatment (off‐treatment) Show forest plot

7

4426

Risk Ratio (IV, Random, 95% CI)

0.80 [0.61, 1.03]

39 Adverse events: musculoskeletal body system in adult treatment (off‐treatment) Show forest plot

7

4394

Risk Ratio (IV, Random, 95% CI)

0.84 [0.54, 1.30]

40 Adverse events: neurological body system in adult treatment (off‐treatment) Show forest plot

6

4368

Risk Ratio (IV, Random, 95% CI)

1.29 [0.87, 1.91]

41 Adverse events: respiratory body system in adult treatment (off‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.94 [0.71, 1.24]

42 Adverse events: skin body system in adult treatment (off‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

0.81 [0.42, 1.56]

43 Adverse events: cough in adult treatment (off‐treatment) Show forest plot

8

4452

Risk Ratio (IV, Random, 95% CI)

1.01 [0.55, 1.85]

44 Adverse events: headache in adult treatment (off‐treatment) Show forest plot

6

4368

Risk Ratio (IV, Random, 95% CI)

1.34 [0.83, 2.15]

45 Adverse events: nausea in adult treatment (off‐treatment) Show forest plot

6

4368

Risk Ratio (IV, Random, 95% CI)

1.05 [0.50, 2.23]

46 Time to first alleviation of symptoms in child treatment [hours] Show forest plot

3

1329

Mean Difference (IV, Random, 95% CI)

‐8.04 [‐33.34, 17.26]

46.1 Otherwise healthy children

1

669

Mean Difference (IV, Random, 95% CI)

‐29.40 [‐47.04, ‐11.76]

46.2 Children with chronic asthma

2

660

Mean Difference (IV, Random, 95% CI)

5.18 [‐11.06, 21.41]

47 Hospital admission in child treatment (safety population) Show forest plot

3

1359

Risk Ratio (IV, Random, 95% CI)

1.92 [0.70, 5.23]

48 Defined as influenza‐infected at baseline in child treatment Show forest plot

3

1359

Risk Ratio (IV, Random, 95% CI)

0.92 [0.84, 1.01]

49 Antibody rise four‐fold or greater in child treatment Show forest plot

2

909

Risk Ratio (M‐H, Random, 95% CI)

0.90 [0.80, 1.00]

50 Complications: bronchitis in child treatment Show forest plot

3

1359

Risk Ratio (IV, Random, 95% CI)

0.65 [0.27, 1.55]

51 Complications: otitis media in child treatment Show forest plot

3

1359

Risk Ratio (IV, Random, 95% CI)

0.80 [0.62, 1.02]

52 Complications: pneumonia in child treatment Show forest plot

3

1359

Risk Ratio (IV, Random, 95% CI)

1.06 [0.62, 1.83]

53 Complications: sinusitis in child treatment Show forest plot

3

1359

Risk Ratio (IV, Random, 95% CI)

1.00 [0.58, 1.72]

54 Complications: pneumonia in child treatment by on‐ and off‐treatment Show forest plot

3

Risk Ratio (IV, Random, 95% CI)

Subtotals only

54.1 On‐treatment

3

1359

Risk Ratio (IV, Random, 95% CI)

0.87 [0.48, 1.60]

54.2 Off‐treatment

3

1359

Risk Ratio (IV, Random, 95% CI)

2.83 [0.52, 15.31]

55 Complications in trials of children classified as serious or leading to study withdrawal Show forest plot

3

1359

Risk Ratio (IV, Random, 95% CI)

1.98 [0.58, 6.72]

56 Withdrawal from child treatment trial due to adverse events Show forest plot

2

1029

Risk Ratio (IV, Random, 95% CI)

0.99 [0.33, 3.01]

57 All withdrawals from child treatment Show forest plot

2

1029

Risk Ratio (IV, Random, 95% CI)

0.94 [0.56, 1.60]

58 Serious adverse events: overall in child treatment (on‐treatment) Show forest plot

2

1029

Risk Ratio (IV, Random, 95% CI)

1.97 [0.59, 6.56]

59 Serious adverse events: overall in child treatment (off‐treatment) Show forest plot

3

1358

Risk Ratio (M‐H, Fixed, 95% CI)

1.80 [0.38, 8.46]

60 Adverse events: abdominal pain in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.10 [0.62, 1.95]

61 Adverse events: diarrhoea in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

0.87 [0.58, 1.28]

62 Adverse events: nausea in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

0.87 [0.50, 1.51]

63 Adverse events: vomiting in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.70 [1.23, 2.35]

64 Adverse events: abdominal pain in child treatment (off‐treatment) Show forest plot

3

1358

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.39, 2.11]

65 Adverse events: cough in child treatment (off‐treatment) Show forest plot

2

1029

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.27, 1.85]

66 Adverse events: diarrhoea in child treatment (off‐treatment) Show forest plot

3

1358

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.36, 1.40]

67 Adverse events: headache in child treatment (off‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.13 [0.55, 2.34]

68 Adverse events: vomiting in child treatment (off‐treatment) Show forest plot

3

1358

Risk Ratio (M‐H, Random, 95% CI)

1.07 [0.57, 2.02]

69 Adverse events: ear body system in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.18 [0.30, 4.56]

70 Adverse events: gastrointestinal body system in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.18 [0.96, 1.44]

71 Adverse events: general body system in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.47, 1.92]

72 Adverse events: infection body system in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

0.75 [0.59, 0.95]

73 Adverse events: neurological body system in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

0.66 [0.17, 2.62]

74 Adverse events: respiratory body system in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.02 [0.73, 1.43]

75 Adverse events: skin body system in child treatment (on‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.26 [0.71, 2.22]

76 Adverse events: ear body system in child treatment (off‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.10 [0.52, 2.32]

77 Adverse events: gastrointestinal body system in child treatment (off‐treatment) Show forest plot

2

1029

Risk Ratio (IV, Random, 95% CI)

1.15 [0.69, 1.91]

78 Adverse events: general body system in child treatment (off‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.00 [0.54, 1.86]

79 Adverse events: infection body system in child treatment (off‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.14 [0.82, 1.58]

80 Adverse events: neurological body system in child treatment (off‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

1.07 [0.51, 2.26]

81 Adverse events: respiratory body system in child treatment (off‐treatment) Show forest plot

3

1358

Risk Ratio (IV, Random, 95% CI)

0.94 [0.65, 1.35]

82 Culture‐positive at baseline in child treatment Show forest plot

3

1359

Risk Ratio (IV, Random, 95% CI)

0.93 [0.83, 1.04]

Figuras y tablas -
Comparison 1. Oseltamivir versus placebo for treatment
Comparison 2. Oseltamivir versus placebo for prophylaxis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptomatic influenza in adult prophylaxis of individuals Show forest plot

3

2479

Risk Ratio (IV, Random, 95% CI)

0.45 [0.30, 0.67]

2 Asymptomatic influenza in adult prophylaxis of individuals Show forest plot

3

2479

Risk Ratio (IV, Random, 95% CI)

0.78 [0.49, 1.24]

3 Symptomatic influenza in household prophylaxis Show forest plot

1

405

Risk Ratio (IV, Random, 95% CI)

0.20 [0.09, 0.44]

4 Asymptomatic influenza in household prophylaxis Show forest plot

1

405

Risk Ratio (IV, Random, 95% CI)

1.14 [0.39, 3.33]

5 Influenza‐like illness reported as adverse event (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.99 [0.73, 1.35]

6 Influenza‐like illness reported as adverse event (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.62 [0.34, 1.16]

7 Hospitalisation in adult prophylaxis (safety population) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.14 [0.66, 1.94]

8 Complications: bronchitis in adult prophylaxis Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.74 [0.41, 1.35]

9 Complications: sinusitis in adult prophylaxis Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.41 [0.75, 2.62]

10 Adverse events leading to study withdrawal in adult prophylaxis Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.11 [0.57, 2.18]

11 All withdrawals in adult prophylaxis Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.15 [0.82, 1.61]

12 Serious adverse events in adult prophylaxis (on‐treatment) Show forest plot

3

2479

Risk Ratio (IV, Random, 95% CI)

0.94 [0.53, 1.66]

13 Serious adverse events in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (M‐H, Fixed, 95% CI)

1.21 [0.57, 2.60]

14 Adverse events: abdominal pain in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (M‐H, Fixed, 95% CI)

1.18 [0.77, 1.82]

15 Adverse events: cough in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.96 [0.68, 1.36]

16 Adverse events: diarrhoea in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.09 [0.64, 1.86]

17 Adverse events: dizziness in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.15 [0.66, 2.01]

18 Adverse events: fatigue in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.12 [0.89, 1.40]

19 Adverse events: headache in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.18 [1.05, 1.33]

20 Adverse events: nausea in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.96 [1.20, 3.20]

21 Adverse events: vomiting in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.91 [0.70, 5.22]

22 Adverse events: cough in adult prophylaxis (off‐treatment) Show forest plot

3

2479

Risk Ratio (IV, Random, 95% CI)

0.72 [0.36, 1.45]

23 Adverse events: fatigue in adult prophylaxis (off‐treatment) Show forest plot

3

2479

Risk Ratio (IV, Random, 95% CI)

1.33 [0.57, 3.13]

24 Adverse events: headache in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.88 [0.63, 1.24]

25 Adverse events: blood body system in adult prophylaxis (on‐treatment) Show forest plot

3

2479

Risk Ratio (IV, Random, 95% CI)

0.99 [0.30, 3.25]

26 Adverse events: cardiac body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.75 [0.36, 1.58]

27 Adverse events: ear body system in adult prophylaxis (on treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.44 [0.61, 3.40]

28 Adverse events: eye body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.01 [0.56, 1.81]

29 Adverse events: gastrointestinal body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.38 [1.17, 1.63]

30 Adverse events: general body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.03 [0.88, 1.20]

31 Adverse events: infection body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.97 [0.84, 1.11]

32 Adverse events: immune body system in adult prophylaxis (on‐treatment) Show forest plot

1

1559

Risk Ratio (IV, Random, 95% CI)

0.86 [0.45, 1.64]

33 Adverse events: injury body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.97 [0.60, 1.56]

34 Adverse events: metabolism body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.36 [0.73, 2.54]

35 Adverse events: musculoskeletal body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.98 [0.79, 1.22]

36 Adverse events: neurological body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.21 [1.03, 1.42]

37 Adverse events: psychiatric body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.81 [0.97, 3.37]

38 Adverse events: renal body system in adult prophylaxis (on‐treatment) Show forest plot

3

2479

Risk Ratio (IV, Random, 95% CI)

3.17 [0.96, 10.49]

39 Adverse events: reproductive body system in adult prophylaxis (on treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.05 [0.77, 1.42]

40 Adverse events: respiratory body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.04 [0.90, 1.20]

41 Adverse events: skin body system in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.92 [0.63, 1.34]

42 Adverse events: surgical events in adult prophylaxis (on‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.98 [0.42, 2.29]

43 Adverse events: vascular body system in adult prophylaxis (on‐treatment) Show forest plot

3

2479

Risk Ratio (IV, Random, 95% CI)

0.90 [0.45, 1.80]

44 Adverse events: cardiac body system in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.50 [0.67, 3.35]

45 Adverse events: gastrointestinal body system in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.98 [0.62, 1.53]

46 Adverse events: general body system in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.02 [0.69, 1.49]

47 Adverse events: infection body system in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.89 [0.68, 1.17]

48 Adverse events: injury body system in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.01 [0.49, 2.09]

49 Adverse events: musculoskeletal body system in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.04 [0.63, 1.72]

50 Adverse events: neurological body system in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.93 [0.68, 1.28]

51 Adverse events: reproductive body system in adult prophylaxis (off‐treatment) Show forest plot

2

2514

Risk Ratio (IV, Random, 95% CI)

0.49 [0.24, 1.00]

52 Adverse events: respiratory body system in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.95 [0.69, 1.32]

53 Adverse events: skin body system in adult prophylaxis (off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

0.73 [0.32, 1.69]

54 Adverse events: psychiatric body system in adult prophylaxis (on and off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

1.80 [1.05, 3.08]

55 Adverse events: renal body system in adult prophylaxis (on and off‐treatment) Show forest plot

4

3434

Risk Ratio (IV, Random, 95% CI)

2.01 [0.74, 5.47]

Figuras y tablas -
Comparison 2. Oseltamivir versus placebo for prophylaxis
Comparison 3. Zanamivir versus placebo for treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Time to first alleviation of symptoms in adult treatment (days) Show forest plot

13

5411

Mean Difference (IV, Random, 95% CI)

‐0.60 [‐0.81, ‐0.39]

2 Complications: pneumonia in adult treatment Show forest plot

11

5876

Risk Ratio (IV, Random, 95% CI)

0.90 [0.58, 1.40]

3 Complications: pneumonia confirmed with X‐ray in adult treatment Show forest plot

2

946

Risk Ratio (IV, Random, 95% CI)

1.02 [0.35, 3.02]

4 Complications: bronchitis in adult treatment Show forest plot

12

6072

Risk Ratio (IV, Random, 95% CI)

0.75 [0.61, 0.91]

5 Complications: sinusitis in adult treatment Show forest plot

12

6072

Risk Ratio (IV, Random, 95% CI)

1.12 [0.84, 1.48]

6 Complications: otitis media in adult treatment Show forest plot

10

5494

Risk Ratio (IV, Random, 95% CI)

0.81 [0.54, 1.20]

7 Complications in adult trials classified as serious or leading to study withdrawal Show forest plot

8

4514

Risk Ratio (IV, Random, 95% CI)

1.10 [0.46, 2.63]

8 Proportion diagnosed as influenza‐infected in adult treatment Show forest plot

15

6569

Risk Ratio (IV, Random, 95% CI)

1.02 [0.98, 1.06]

9 Proportion with four‐fold rise in antibody titre in adult treatment Show forest plot

13

5113

Risk Ratio (IV, Random, 95% CI)

1.01 [0.96, 1.06]

10 Proportion with positive culture at baseline in adult treatment Show forest plot

12

5995

Risk Ratio (IV, Random, 95% CI)

1.01 [0.96, 1.05]

11 Serious adverse events in adult treatment Show forest plot

10

4388

Risk Ratio (IV, Random, 95% CI)

0.86 [0.49, 1.50]

12 Adverse events leading to study withdrawal in adult treatment Show forest plot

13

6116

Risk Ratio (IV, Random, 95% CI)

0.96 [0.66, 1.39]

13 All withdrawals in adult treatment Show forest plot

12

6065

Risk Difference (IV, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

14 Time to first alleviation of symptoms in children (days) Show forest plot

2

723

Mean Difference (IV, Random, 95% CI)

‐1.08 [‐2.32, 0.15]

15 Complications: pneumonia in child treatment Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

0.53 [0.12, 2.38]

16 Complications: bronchitis in child treatment Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

0.86 [0.26, 2.80]

17 Complications: sinusitis in child treatment Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

0.87 [0.12, 6.45]

18 Complications: otitis media in child treatment Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

1.00 [0.59, 1.72]

19 Proportion diagnosed as influenza‐infected in child treatment Show forest plot

1

471

Risk Ratio (IV, Random, 95% CI)

0.99 [0.89, 1.11]

20 Proportion with four‐fold increase in antibodies in child treatment Show forest plot

1

431

Risk Ratio (IV, Random, 95% CI)

1.02 [0.86, 1.20]

21 Proportion with positive culture at baseline in child treatment Show forest plot

1

469

Risk Ratio (IV, Random, 95% CI)

1.06 [0.87, 1.27]

22 All withdrawals in child treatment Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

1.18 [0.16, 8.88]

23 Adverse events: nausea and vomiting in child treatment (on‐treatment) Show forest plot

2

737

Odds Ratio (IV, Random, 95% CI)

0.54 [0.24, 1.22]

24 Adverse events: diarrhoea in child treatment (on‐treatment) Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

0.52 [0.15, 1.75]

25 Adverse events: gastrointestinal body system in child treatment (on‐treatment) Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

0.95 [0.52, 1.73]

26 Adverse events: respiratory body system in child treatment (on‐treatment) Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

0.56 [0.29, 1.10]

27 Adverse events: neurological body system in child treatment (on‐treatment) Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

0.61 [0.20, 1.85]

28 Adverse events: ear, nose and throat body system in child treatment (on‐treatment) Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

1.02 [0.63, 1.67]

29 Adverse events: skin body system in child treatment (on‐treatment) Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

1.01 [0.34, 2.98]

30 Adverse events: gastrointestinal body system in child treatment (off‐treatment) Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

1.39 [0.50, 3.83]

31 Adverse events: ear nose and throat body system in child treatment (off‐treatment) Show forest plot

2

737

Risk Ratio (IV, Random, 95% CI)

0.93 [0.54, 1.63]

32 Adverse events: nausea/vomiting in adult treatment (on‐treatment) Show forest plot

15

6553

Risk Ratio (IV, Random, 95% CI)

0.60 [0.39, 0.94]

33 Adverse events: diarrhoea in adult treatment (on‐treatment) Show forest plot

15

6553

Risk Ratio (IV, Random, 95% CI)

0.87 [0.66, 1.14]

34 Adverse events: dizziness in adult treatment (on‐treatment) Show forest plot

13

5641

Risk Ratio (IV, Random, 95% CI)

1.20 [0.68, 2.15]

35 Adverse events: headache in adult treatment (on‐treatment) Show forest plot

15

6553

Risk Ratio (IV, Random, 95% CI)

0.84 [0.60, 1.18]

36 Adverse events: cough in adult treatment (on‐treatment) Show forest plot

15

6553

Risk Ratio (IV, Random, 95% CI)

0.69 [0.49, 0.96]

37 Adverse events: gastrointestinal body system in adult treatment (on‐treatment) Show forest plot

15

6453

Risk Ratio (IV, Random, 95% CI)

0.89 [0.72, 1.09]

38 Adverse events: respiratory body system in adult treatment (on‐treatment) Show forest plot

15

6553

Risk Ratio (IV, Random, 95% CI)

0.81 [0.67, 0.97]

39 Adverse events: neurological body system in adult treatment (on‐treatment) Show forest plot

15

6553

Risk Ratio (IV, Random, 95% CI)

1.03 [0.82, 1.29]

40 Adverse events: ear, nose and throat body system in adult treatment (on‐treatment) Show forest plot

14

6229

Risk Ratio (IV, Random, 95% CI)

0.89 [0.76, 1.05]

41 Adverse events: skin body system in adult treatment (on‐treatment) Show forest plot

13

6181

Risk Ratio (IV, Random, 95% CI)

0.84 [0.60, 1.18]

42 Adverse events: musculoskeletal body system in adult treatment (on‐treatment) Show forest plot

15

6553

Risk Ratio (IV, Random, 95% CI)

0.72 [0.49, 1.04]

43 Adverse events: eye body system in adult treatment (on‐treatment) Show forest plot

13

6181

Risk Ratio (IV, Random, 95% CI)

0.98 [0.55, 1.74]

44 Adverse events: hepato body system in adult treatment (on‐treatment) Show forest plot

9

4788

Risk Ratio (IV, Random, 95% CI)

0.83 [0.39, 1.76]

45 Adverse events: renal body system in adult treatment (on‐treatment) Show forest plot

11

5205

Risk Ratio (IV, Random, 95% CI)

0.84 [0.41, 1.72]

46 Adverse events: cardiovascular body system in adult treatment (on‐treatment) Show forest plot

11

5204

Risk Ratio (IV, Random, 95% CI)

0.98 [0.50, 1.91]

47 Adverse events: blood body system in adult treatment (on‐treatment) Show forest plot

11

5272

Risk Ratio (IV, Random, 95% CI)

0.80 [0.43, 1.49]

48 Adverse events: psychiatric body system in adult treatment (on‐treatment) Show forest plot

10

4732

Risk Ratio (IV, Random, 95% CI)

1.16 [0.57, 2.38]

49 Adverse events: reproduction body system in adult treatment (on‐treatment) Show forest plot

9

4924

Risk Ratio (IV, Random, 95% CI)

0.68 [0.33, 1.43]

50 Adverse events: endocrine and metabolic body system in adult treatment (on‐treatment) Show forest plot

11

5477

Risk Ratio (IV, Random, 95% CI)

0.94 [0.58, 1.53]

51 Adverse events: injury body system in adult treatment (on‐treatment) Show forest plot

9

5293

Risk Ratio (IV, Random, 95% CI)

1.22 [0.57, 2.60]

52 Adverse events: non‐site specific events in adult treatment (on‐treatment) Show forest plot

12

6065

Risk Ratio (IV, Random, 95% CI)

1.04 [0.78, 1.39]

53 Adverse events: nausea/vomiting in adult treatment (off‐treatment) Show forest plot

10

5403

Risk Ratio (IV, Random, 95% CI)

1.12 [0.67, 1.85]

54 Adverse events: cough in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

0.96 [0.71, 1.29]

55 Adverse events: respiratory body system in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

0.90 [0.71, 1.14]

56 Adverse events: headache in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

0.91 [0.69, 1.20]

57 Adverse events: diarrhoea in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

1.01 [0.59, 1.72]

58 Adverse events: fatigue in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

0.70 [0.37, 1.32]

59 Adverse events: gastrointestinal body system in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

0.97 [0.73, 1.29]

60 Adverse events: neurological body system in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

0.91 [0.72, 1.16]

61 Adverse events: ear, nose and throat in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

1.04 [0.91, 1.19]

62 Adverse events: skin body system in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

1.10 [0.68, 1.78]

63 Adverse events: musculoskeletal body system in adult treatment (off‐treatment) Show forest plot

11

5369

Risk Ratio (IV, Random, 95% CI)

1.16 [0.87, 1.55]

64 Adverse events: non‐site specific in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

0.76 [0.56, 1.03]

65 Adverse events: injury body system in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

1.14 [0.60, 2.15]

66 Adverse events: endocrine and metabolic body system in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

0.90 [0.49, 1.68]

67 Adverse events: eye body system in adult treatment (off‐treatment) Show forest plot

11

5599

Risk Ratio (IV, Random, 95% CI)

1.11 [0.55, 2.24]

68 Time to first alleviation of symptoms in adults with/without relief medication [days] Show forest plot

7

3396

Mean Difference (IV, Random, 95% CI)

0.41 [‐0.47, 1.29]

69 Time to first alleviation of symptoms in adults by infection status [days] Show forest plot

12

4873

Mean Difference (IV, Random, 95% CI)

‐0.57 [‐0.78, ‐0.37]

69.1 Influenza‐infected

12

3233

Mean Difference (IV, Random, 95% CI)

‐0.67 [‐0.99, ‐0.35]

69.2 Not influenza‐infected

12

1640

Mean Difference (IV, Random, 95% CI)

‐0.52 [‐0.86, ‐0.18]

Figuras y tablas -
Comparison 3. Zanamivir versus placebo for treatment
Comparison 4. Zanamivir versus placebo for prophylaxis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptomatic influenza in prophylaxis of individuals Show forest plot

4

5275

Risk Ratio (IV, Random, 95% CI)

0.39 [0.22, 0.70]

2 Asymptomatic influenza in prophylaxis of individuals Show forest plot

4

5275

Risk Ratio (IV, Random, 95% CI)

0.97 [0.76, 1.24]

3 Symptomatic influenza in post‐exposure prophylaxis Show forest plot

5

1525

Risk Ratio (IV, Random, 95% CI)

0.33 [0.18, 0.58]

3.1 Household prophylaxis

2

824

Risk Ratio (IV, Random, 95% CI)

0.22 [0.13, 0.36]

3.2 Other prophylaxis

3

701

Risk Ratio (IV, Random, 95% CI)

0.59 [0.30, 1.16]

4 Asymptomatic influenza in post‐exposure prophylaxis Show forest plot

5

1525

Risk Ratio (IV, Random, 95% CI)

0.88 [0.65, 1.20]

5 Complications: pneumonia in adult prophylaxis Show forest plot

6

7662

Risk Ratio (IV, Random, 95% CI)

0.30 [0.11, 0.80]

6 Complications: bronchitis in adult prophylaxis Show forest plot

6

7662

Risk Ratio (IV, Random, 95% CI)

0.49 [0.20, 1.19]

7 Complications: sinusitis in adult prophylaxis Show forest plot

6

7662

Risk Ratio (IV, Random, 95% CI)

0.93 [0.64, 1.36]

8 Complications classified as serious or leading to study withdrawal Show forest plot

5

6825

Risk Ratio (IV, Random, 95% CI)

1.09 [0.36, 3.26]

9 Serious adverse events in adult prophylaxis Show forest plot

10

8225

Risk Ratio (IV, Random, 95% CI)

1.12 [0.65, 1.91]

10 Adverse events leading to study withdrawal in adult prophylaxis Show forest plot

10

8225

Risk Ratio (IV, Random, 95% CI)

0.85 [0.60, 1.21]

11 All withdrawals in adult prophylaxis Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

0.81 [0.64, 1.03]

12 Adverse events: abdominal pain in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

1.28 [0.55, 2.99]

13 Adverse events: cough in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

0.91 [0.82, 1.01]

14 Adverse events: diarrhoea in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

1.01 [0.73, 1.40]

15 Adverse events: dizziness in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

1.07 [0.59, 1.96]

16 Adverse events: fatigue in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

1.01 [0.88, 1.16]

17 Adverse events: headache in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

0.96 [0.89, 1.04]

18 Adverse events: blood body system in adult prophylaxis (on‐treatment) Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

1.18 [0.62, 2.25]

19 Adverse events: nausea/vomiting in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

0.88 [0.66, 1.18]

20 Adverse events: cardiovascular body system in adult prophylaxis (on‐treatment) Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

1.15 [0.77, 1.71]

21 Adverse events: ear, nose and throat body system in adult prophylaxis (on‐treatment) Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

0.94 [0.87, 1.01]

22 Adverse events: endocrine and metabolic body system in adult prophylaxis (on‐treatment) Show forest plot

7

7730

Risk Ratio (IV, Random, 95% CI)

0.86 [0.69, 1.08]

23 Adverse events: eye body system in adult prophylaxis (on‐treatment) Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

0.79 [0.51, 1.21]

24 Adverse events: gastrointestinal body system in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

0.83 [0.72, 0.97]

25 Adverse events: injury body system in adult prophylaxis (on‐treatment) Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

0.92 [0.62, 1.35]

26 Adverse events: musculoskeletal body system in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

1.05 [0.93, 1.19]

27 Adverse events: neurological body system in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

0.96 [0.89, 1.03]

28 Adverse events: non‐site specific in adult prophylaxis (on‐treatment) Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

0.99 [0.85, 1.16]

29 Adverse events: psychiatric body system in adult prophylaxis (on‐treatment) Show forest plot

7

7730

Risk Ratio (IV, Random, 95% CI)

1.05 [0.48, 2.29]

30 Adverse events: renal body system in adult prophylaxis (on‐treatment) Show forest plot

7

7730

Risk Ratio (IV, Random, 95% CI)

0.67 [0.35, 1.26]

31 Adverse events: reproductive body system in adult prophylaxis (on‐treatment) Show forest plot

10

8153

Risk Ratio (IV, Random, 95% CI)

0.77 [0.55, 1.09]

32 Adverse events: respiratory body system in adult prophylaxis (on‐treatment) Show forest plot

9

8109

Risk Ratio (IV, Random, 95% CI)

0.87 [0.80, 0.94]

33 Adverse events: skin body system in adult prophylaxis (on‐treatment) Show forest plot

8

7774

Risk Ratio (IV, Random, 95% CI)

0.92 [0.58, 1.45]

34 Adverse events: gastrointestinal body system in adult prophylaxis (off‐treatment) Show forest plot

9

8109

Risk Ratio (IV, Random, 95% CI)

0.84 [0.63, 1.13]

35 Adverse events: respiratory body system in adult prophylaxis (off‐treatment) Show forest plot

9

8109

Risk Ratio (IV, Random, 95% CI)

0.79 [0.54, 1.15]

36 Adverse events: nausea/vomiting in prophylaxis (off‐treatment) Show forest plot

9

8109

Risk Ratio (IV, Random, 95% CI)

0.80 [0.39, 1.67]

37 Adverse events: diarrhoea in prophylaxis (off‐treatment) Show forest plot

9

8109

Risk Ratio (IV, Random, 95% CI)

0.92 [0.54, 1.57]

38 Adverse events: headache in prophylaxis (off‐treatment) Show forest plot

9

8109

Risk Ratio (IV, Random, 95% CI)

0.95 [0.76, 1.19]

39 Adverse events: cough in prophylaxis (off‐treatment) Show forest plot

9

8109

Risk Ratio (IV, Random, 95% CI)

1.31 [0.99, 1.73]

40 Adverse events: fatigue in prophylaxis (off‐treatment) Show forest plot

9

8109

Risk Ratio (IV, Random, 95% CI)

0.74 [0.47, 1.16]

41 Adverse events: neurological body system in prophylaxis (off‐treatment) Show forest plot

9

8109

Risk Ratio (IV, Random, 95% CI)

1.01 [0.82, 1.24]

42 Adverse events: ear, nose and throat in prophylaxis (off‐treatment) Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

0.99 [0.84, 1.17]

43 Adverse events: musculoskeletal body system in prophylaxis (off‐treatment) Show forest plot

9

8109

Risk Ratio (IV, Random, 95% CI)

1.03 [0.77, 1.39]

44 Adverse events: non‐site specific in prophylaxis (off‐treatment) Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

0.99 [0.74, 1.32]

45 Adverse events: injury in prophylaxis (off‐treatment) Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

0.61 [0.34, 1.10]

46 Adverse events: endocrine and metabolic in prophylaxis (off‐treatment) Show forest plot

8

7792

Risk Ratio (IV, Random, 95% CI)

1.04 [0.60, 1.83]

Figuras y tablas -
Comparison 4. Zanamivir versus placebo for prophylaxis
Comparison 5. Neuraminidase inhibitor versus placebo for treatment or prophylaxis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Complications: pneumonia Show forest plot

32

22565

Risk Ratio (IV, Random, 95% CI)

0.72 [0.55, 0.95]

1.1 Unclear diagnostic confirmation capture

25

18905

Risk Ratio (IV, Random, 95% CI)

0.51 [0.35, 0.75]

1.2 Clear diagnostic confirmation capture

7

3660

Risk Ratio (IV, Random, 95% CI)

1.01 [0.69, 1.47]

Figuras y tablas -
Comparison 5. Neuraminidase inhibitor versus placebo for treatment or prophylaxis