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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figures and Tables -
Figure 1

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Funnel plot of comparison: 1 Maintenance versus increased dose, outcome: 1.1 Need for systemic corticosteroids ‐ parallel‐group studies.
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Figure 2

Funnel plot of comparison: 1 Maintenance versus increased dose, outcome: 1.1 Need for systemic corticosteroids ‐ parallel‐group studies.

Comparison 1 Maintenance versus increased dose, Outcome 1 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis).
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Analysis 1.1

Comparison 1 Maintenance versus increased dose, Outcome 1 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis).

Comparison 1 Maintenance versus increased dose, Outcome 2 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by age.
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Analysis 1.2

Comparison 1 Maintenance versus increased dose, Outcome 2 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by age.

Comparison 1 Maintenance versus increased dose, Outcome 3 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by smoking status.
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Analysis 1.3

Comparison 1 Maintenance versus increased dose, Outcome 3 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by smoking status.

Comparison 1 Maintenance versus increased dose, Outcome 4 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by time elapsed before treatment initiation.
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Analysis 1.4

Comparison 1 Maintenance versus increased dose, Outcome 4 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by time elapsed before treatment initiation.

Comparison 1 Maintenance versus increased dose, Outcome 5 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by maintenance ICS dose.
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Analysis 1.5

Comparison 1 Maintenance versus increased dose, Outcome 5 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by maintenance ICS dose.

Comparison 1 Maintenance versus increased dose, Outcome 6 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by achieved ICS dose.
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Analysis 1.6

Comparison 1 Maintenance versus increased dose, Outcome 6 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by achieved ICS dose.

Comparison 1 Maintenance versus increased dose, Outcome 7 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by x2 or x4.
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Analysis 1.7

Comparison 1 Maintenance versus increased dose, Outcome 7 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by x2 or x4.

Comparison 1 Maintenance versus increased dose, Outcome 8 Need for systemic corticosteroids ‐ cross‐over studies.
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Analysis 1.8

Comparison 1 Maintenance versus increased dose, Outcome 8 Need for systemic corticosteroids ‐ cross‐over studies.

Comparison 1 Maintenance versus increased dose, Outcome 9 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis).
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Analysis 1.9

Comparison 1 Maintenance versus increased dose, Outcome 9 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis).

Comparison 1 Maintenance versus increased dose, Outcome 10 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by age.
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Analysis 1.10

Comparison 1 Maintenance versus increased dose, Outcome 10 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by age.

Comparison 1 Maintenance versus increased dose, Outcome 11 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by smoking status.
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Analysis 1.11

Comparison 1 Maintenance versus increased dose, Outcome 11 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by smoking status.

Comparison 1 Maintenance versus increased dose, Outcome 12 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by time elapsed before treatment initiation.
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Analysis 1.12

Comparison 1 Maintenance versus increased dose, Outcome 12 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by time elapsed before treatment initiation.

Comparison 1 Maintenance versus increased dose, Outcome 13 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by maintenance ICS dose.
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Analysis 1.13

Comparison 1 Maintenance versus increased dose, Outcome 13 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by maintenance ICS dose.

Comparison 1 Maintenance versus increased dose, Outcome 14 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by achieved ICS dose.
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Analysis 1.14

Comparison 1 Maintenance versus increased dose, Outcome 14 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by achieved ICS dose.

Comparison 1 Maintenance versus increased dose, Outcome 15 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by x2 or x4.
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Analysis 1.15

Comparison 1 Maintenance versus increased dose, Outcome 15 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by x2 or x4.

Comparison 1 Maintenance versus increased dose, Outcome 16 Sensitivity analysis ‐ effect of funding on need for systemic corticosteroids ‐ parallel‐group studies.
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Analysis 1.16

Comparison 1 Maintenance versus increased dose, Outcome 16 Sensitivity analysis ‐ effect of funding on need for systemic corticosteroids ‐ parallel‐group studies.

Comparison 1 Maintenance versus increased dose, Outcome 17 Unscheduled physician visits ‐ parallel‐group studies.
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Analysis 1.17

Comparison 1 Maintenance versus increased dose, Outcome 17 Unscheduled physician visits ‐ parallel‐group studies.

Comparison 1 Maintenance versus increased dose, Outcome 18 Unscheduled acute care or emergency department visits or need for hospital admission ‐ parallel‐group studies.
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Analysis 1.18

Comparison 1 Maintenance versus increased dose, Outcome 18 Unscheduled acute care or emergency department visits or need for hospital admission ‐ parallel‐group studies.

Comparison 1 Maintenance versus increased dose, Outcome 19 Unscheduled acute care or emergency department visits or need for hospital admission ‐ cross‐over studies.
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Analysis 1.19

Comparison 1 Maintenance versus increased dose, Outcome 19 Unscheduled acute care or emergency department visits or need for hospital admission ‐ cross‐over studies.

Comparison 1 Maintenance versus increased dose, Outcome 20 Duration of exacerbation as defined by time to recovery of lung function.
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Analysis 1.20

Comparison 1 Maintenance versus increased dose, Outcome 20 Duration of exacerbation as defined by time to recovery of lung function.

Comparison 1 Maintenance versus increased dose, Outcome 21 Duration of exacerbation as defined by time to recovery of symptoms.
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Analysis 1.21

Comparison 1 Maintenance versus increased dose, Outcome 21 Duration of exacerbation as defined by time to recovery of symptoms.

Comparison 1 Maintenance versus increased dose, Outcome 22 Non‐serious adverse events.
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Analysis 1.22

Comparison 1 Maintenance versus increased dose, Outcome 22 Non‐serious adverse events.

Comparison 1 Maintenance versus increased dose, Outcome 23 Non‐serious adverse event ‐ pharyngitis.
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Analysis 1.23

Comparison 1 Maintenance versus increased dose, Outcome 23 Non‐serious adverse event ‐ pharyngitis.

Comparison 1 Maintenance versus increased dose, Outcome 24 Non‐serious adverse event ‐ glossitis.
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Analysis 1.24

Comparison 1 Maintenance versus increased dose, Outcome 24 Non‐serious adverse event ‐ glossitis.

Comparison 1 Maintenance versus increased dose, Outcome 25 Non‐serious adverse event ‐ headaches.
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Analysis 1.25

Comparison 1 Maintenance versus increased dose, Outcome 25 Non‐serious adverse event ‐ headaches.

Comparison 1 Maintenance versus increased dose, Outcome 26 Non‐serious adverse event ‐ psychiatric disturbance (depression, anxiety).
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Analysis 1.26

Comparison 1 Maintenance versus increased dose, Outcome 26 Non‐serious adverse event ‐ psychiatric disturbance (depression, anxiety).

Comparison 1 Maintenance versus increased dose, Outcome 28 Non‐serious adverse event ‐ GI (nausea, abdominal discomfort).
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Analysis 1.28

Comparison 1 Maintenance versus increased dose, Outcome 28 Non‐serious adverse event ‐ GI (nausea, abdominal discomfort).

Comparison 1 Maintenance versus increased dose, Outcome 29 Non‐serious adverse event ‐ upper respiratory tract infections.
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Analysis 1.29

Comparison 1 Maintenance versus increased dose, Outcome 29 Non‐serious adverse event ‐ upper respiratory tract infections.

Summary of findings for the main comparison. Increased compared to stable inhaled steroid dose for exacerbations of chronic asthma in adults and children

Increased compared to stable inhaled steroid dose for exacerbations of chronic asthma in adults and children

Patient or population: patients with exacerbations of chronic asthma (adults and children)
Settings: home‐based asthma action plan
Intervention: increase inhaled steroid dose
Comparison: maintenance inhaled steroid dose

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Maintenance inhaled steroid dose

Increased inhaled steroid dose

Need for rescue oral corticosteroids ‐ parallel‐group studies (ITT analysis)

113 per 1000

98 per 1000
(62 to 154)

OR 0.85
(0.58 to 1.26)

1080
(3 studies)

⊕⊕⊕⊝
moderate1

Non‐serious adverse events

72 per 1000

143 per 1000
(50 to 343)

OR 2.15
(0.68 to 6.73)

142
(2 studies)

⊕⊕⊕⊝
moderate1

No serious adverse events were reported.

*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; OR: Odds ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Few events and wide confidence interval.

Figures and Tables -
Summary of findings for the main comparison. Increased compared to stable inhaled steroid dose for exacerbations of chronic asthma in adults and children
Comparison 1. Maintenance versus increased dose

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) Show forest plot

3

1080

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.58, 1.26]

2 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by age Show forest plot

2

790

Odds Ratio (M‐H, Fixed, 95% CI)

0.75 [0.49, 1.16]

2.1 Children (< 15 years old)

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Adults (> or = 15 years old)

2

790

Odds Ratio (M‐H, Fixed, 95% CI)

0.75 [0.49, 1.16]

3 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by smoking status Show forest plot

1

290

Odds Ratio (M‐H, Fixed, 95% CI)

1.43 [0.58, 3.50]

3.1 Active smokers

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Ex‐ or never‐smokers

1

290

Odds Ratio (M‐H, Fixed, 95% CI)

1.43 [0.58, 3.50]

4 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by time elapsed before treatment initiation Show forest plot

2

680

Odds Ratio (M‐H, Fixed, 95% CI)

1.07 [0.65, 1.78]

4.1 Time elapsed before initiation (< 48h)

1

390

Odds Ratio (M‐H, Fixed, 95% CI)

0.94 [0.51, 1.74]

4.2 Time elapsed before initiation (> or = 48h)

1

290

Odds Ratio (M‐H, Fixed, 95% CI)

1.43 [0.58, 3.50]

5 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by maintenance ICS dose Show forest plot

3

1080

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.58, 1.26]

5.1 Maintenance ICS dose ‐ Low

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 Maintenance ICS dose ‐ Moderate

3

1080

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.58, 1.26]

5.3 Maintenance ICS dose ‐ High

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by achieved ICS dose Show forest plot

3

1080

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.58, 1.26]

6.1 Achieved ICS dose ‐ Low

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Achieved ICS dose ‐ Moderate

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.3 Achieved ICS dose ‐ High

3

1080

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.58, 1.26]

7 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by x2 or x4 Show forest plot

3

1080

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.58, 1.26]

7.1 Double dose

2

680

Odds Ratio (M‐H, Fixed, 95% CI)

1.07 [0.65, 1.78]

7.2 Quadruple dose

1

400

Odds Ratio (M‐H, Fixed, 95% CI)

0.60 [0.32, 1.13]

8 Need for systemic corticosteroids ‐ cross‐over studies Show forest plot

1

36

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.84 [0.47, 130.46]

9 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) Show forest plot

3

399

Odds Ratio (M‐H, Random, 95% CI)

0.68 [0.27, 1.74]

10 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by age Show forest plot

2

301

Odds Ratio (M‐H, Random, 95% CI)

0.46 [0.18, 1.18]

10.1 Children (< 15 years old)

0

0

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Adults (> or = 15 years old)

2

301

Odds Ratio (M‐H, Random, 95% CI)

0.46 [0.18, 1.18]

11 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by smoking status Show forest plot

1

98

Odds Ratio (M‐H, Fixed, 95% CI)

1.69 [0.64, 4.47]

11.1 Active smokers

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.2 Ex‐ or never‐smokers

1

98

Odds Ratio (M‐H, Fixed, 95% CI)

1.69 [0.64, 4.47]

12 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by time elapsed before treatment initiation Show forest plot

2

305

Odds Ratio (M‐H, Random, 95% CI)

1.02 [0.44, 2.34]

12.1 Time elapsed before initiation (< 48 h)

1

207

Odds Ratio (M‐H, Random, 95% CI)

0.71 [0.36, 1.41]

12.2 Time elapsed before initiation (> or = 48 h)

1

98

Odds Ratio (M‐H, Random, 95% CI)

1.69 [0.64, 4.47]

13 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by maintenance ICS dose Show forest plot

3

399

Odds Ratio (M‐H, Random, 95% CI)

0.68 [0.27, 1.74]

13.1 Maintenance ICS dose ‐ Low

0

0

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 Maintenance ICS dose ‐ Moderate

3

399

Odds Ratio (M‐H, Random, 95% CI)

0.68 [0.27, 1.74]

13.3 Maintenance ICS dose ‐ High

0

0

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

14 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by achieved ICS dose Show forest plot

3

399

Odds Ratio (M‐H, Random, 95% CI)

0.68 [0.27, 1.74]

14.1 Achieved ICS dose ‐ Low

0

0

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 Achieved ICS dose ‐ Moderate

0

0

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

14.3 Achieved ICS dose ‐ High

3

399

Odds Ratio (M‐H, Random, 95% CI)

0.68 [0.27, 1.74]

15 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by x2 or x4 Show forest plot

3

399

Odds Ratio (M‐H, Random, 95% CI)

0.68 [0.27, 1.74]

15.1 Double dose

2

305

Odds Ratio (M‐H, Random, 95% CI)

1.02 [0.44, 2.34]

15.2 Quadruple dose

1

94

Odds Ratio (M‐H, Random, 95% CI)

0.27 [0.11, 0.67]

16 Sensitivity analysis ‐ effect of funding on need for systemic corticosteroids ‐ parallel‐group studies Show forest plot

2

301

Odds Ratio (M‐H, Random, 95% CI)

0.46 [0.18, 1.18]

17 Unscheduled physician visits ‐ parallel‐group studies Show forest plot

2

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

18 Unscheduled acute care or emergency department visits or need for hospital admission ‐ parallel‐group studies Show forest plot

1

98

Peto Odds Ratio (Peto, Fixed, 95% CI)

8.42 [0.17, 427.40]

19 Unscheduled acute care or emergency department visits or need for hospital admission ‐ cross‐over studies Show forest plot

1

38

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.0 [0.0, 0.0]

20 Duration of exacerbation as defined by time to recovery of lung function Show forest plot

1

207

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

21 Duration of exacerbation as defined by time to recovery of symptoms Show forest plot

1

207

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

22 Non‐serious adverse events Show forest plot

2

142

Odds Ratio (M‐H, Fixed, 95% CI)

2.15 [0.68, 6.73]

23 Non‐serious adverse event ‐ pharyngitis Show forest plot

2

142

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.46 [0.18, 11.58]

24 Non‐serious adverse event ‐ glossitis Show forest plot

2

142

Peto Odds Ratio (Peto, Fixed, 95% CI)

9.36 [0.54, 163.45]

25 Non‐serious adverse event ‐ headaches Show forest plot

1

94

Peto Odds Ratio (Peto, Fixed, 95% CI)

5.36 [0.10, 290.73]

26 Non‐serious adverse event ‐ psychiatric disturbance (depression, anxiety) Show forest plot

1

94

Peto Odds Ratio (Peto, Fixed, 95% CI)

5.36 [0.10, 290.73]

27 Non‐serious adverse event ‐ oral candidiasis

0

0

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.0 [0.0, 0.0]

28 Non‐serious adverse event ‐ GI (nausea, abdominal discomfort) Show forest plot

1

94

Odds Ratio (M‐H, Fixed, 95% CI)

2.85 [0.31, 26.51]

29 Non‐serious adverse event ‐ upper respiratory tract infections Show forest plot

1

94

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.33 [0.03, 3.38]

30 Non‐serious adverse event ‐ change in appetite

0

0

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.0 [0.0, 0.0]

31 Non‐serious adverse event ‐ dysphonia

0

0

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figures and Tables -
Comparison 1. Maintenance versus increased dose