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Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

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

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 Transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 1 Mortality at any time point.
Figuras y tablas -
Analysis 1.1

Comparison 1 Transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 1 Mortality at any time point.

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Comparison 1 Transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 2 AEs.
Figuras y tablas -
Analysis 1.2

Comparison 1 Transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 2 AEs.

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Comparison 1 Transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 3 Discontinuations due to serious AEs.
Figuras y tablas -
Analysis 1.3

Comparison 1 Transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 3 Discontinuations due to serious AEs.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 1 Mortality at any time point.
Figuras y tablas -
Analysis 2.1

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 1 Mortality at any time point.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 2 LVEF (%): least squares mean change from baseline.
Figuras y tablas -
Analysis 2.2

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 2 LVEF (%): least squares mean change from baseline.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 3 LVEF (# participants affected).
Figuras y tablas -
Analysis 2.3

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 3 LVEF (# participants affected).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 4 Incidence of thyroid disease at end of study.
Figuras y tablas -
Analysis 2.4

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 4 Incidence of thyroid disease at end of study.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 5 ALT (# participants affected): improvement from abnormal to normal range.
Figuras y tablas -
Analysis 2.5

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 5 ALT (# participants affected): improvement from abnormal to normal range.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 6 ALT (U/L) at end of study.
Figuras y tablas -
Analysis 2.6

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 6 ALT (U/L) at end of study.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 7 AST (U/L) at end of study.
Figuras y tablas -
Analysis 2.7

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 7 AST (U/L) at end of study.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 8 Serum creatinine (mg/dL) at end of study.
Figuras y tablas -
Analysis 2.8

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 8 Serum creatinine (mg/dL) at end of study.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 9 Blood urea (mg/dL): mean at end of study.
Figuras y tablas -
Analysis 2.9

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 9 Blood urea (mg/dL): mean at end of study.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 10 Serum ferritin (ng/mL): mean change from baseline and at end of study.
Figuras y tablas -
Analysis 2.10

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 10 Serum ferritin (ng/mL): mean change from baseline and at end of study.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 11 Sensitivity analysis: serum ferritin (ng/mL): mean change from baseline.
Figuras y tablas -
Analysis 2.11

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 11 Sensitivity analysis: serum ferritin (ng/mL): mean change from baseline.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 12 Liver R2* (Hz): mean change from baseline.
Figuras y tablas -
Analysis 2.12

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 12 Liver R2* (Hz): mean change from baseline.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 13 LIC (mg/g) evaluated by MRI (R2/R2*): mean change from baseline.
Figuras y tablas -
Analysis 2.13

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 13 LIC (mg/g) evaluated by MRI (R2/R2*): mean change from baseline.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 14 LIC (mg Fe/g dw) evaluated by biopsy or SQUID: mean change from baseline.
Figuras y tablas -
Analysis 2.14

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 14 LIC (mg Fe/g dw) evaluated by biopsy or SQUID: mean change from baseline.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 15 Responder analysis I (responder: fall in LIC > 10%).
Figuras y tablas -
Analysis 2.15

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 15 Responder analysis I (responder: fall in LIC > 10%).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 16 Responder analysis II (responder: LIC 1 to < 7 mg Fe/g dw).
Figuras y tablas -
Analysis 2.16

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 16 Responder analysis II (responder: LIC 1 to < 7 mg Fe/g dw).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 17 Myocardial T2* (ms): mean change from baseline.
Figuras y tablas -
Analysis 2.17

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 17 Myocardial T2* (ms): mean change from baseline.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 18 Myocardial iron concentration derived from T2* value (mg Fe/g dw): change from baseline.
Figuras y tablas -
Analysis 2.18

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 18 Myocardial iron concentration derived from T2* value (mg Fe/g dw): change from baseline.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 19 Myocardial T2* (# participants affected).
Figuras y tablas -
Analysis 2.19

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 19 Myocardial T2* (# participants affected).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 20 Iron excretion‐intake ratio.
Figuras y tablas -
Analysis 2.20

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 20 Iron excretion‐intake ratio.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 21 Any serious AEs (# participants affected).
Figuras y tablas -
Analysis 2.21

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 21 Any serious AEs (# participants affected).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 22 Serious AEs.
Figuras y tablas -
Analysis 2.22

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 22 Serious AEs.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 23 Any AE (# participants affected).
Figuras y tablas -
Analysis 2.23

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 23 Any AE (# participants affected).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 24 AEs.
Figuras y tablas -
Analysis 2.24

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 24 AEs.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 25 Any drug‐related AE (# participants affected).
Figuras y tablas -
Analysis 2.25

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 25 Any drug‐related AE (# participants affected).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 26 Drug‐related AEs.
Figuras y tablas -
Analysis 2.26

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 26 Drug‐related AEs.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 27 Satisfaction with treatment (very satisfied or satisfied).
Figuras y tablas -
Analysis 2.27

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 27 Satisfaction with treatment (very satisfied or satisfied).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 28 Convenience (good or very good).
Figuras y tablas -
Analysis 2.28

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 28 Convenience (good or very good).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 29 Willingness to continue treatment.
Figuras y tablas -
Analysis 2.29

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 29 Willingness to continue treatment.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 30 Time lost from normal activities due to treatment (hours/month): participants treated previously with DFO.
Figuras y tablas -
Analysis 2.30

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 30 Time lost from normal activities due to treatment (hours/month): participants treated previously with DFO.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 31 Adherence (% of planned dose).
Figuras y tablas -
Analysis 2.31

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 31 Adherence (% of planned dose).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 32 Discontinuations.
Figuras y tablas -
Analysis 2.32

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 32 Discontinuations.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 33 Dose adjustments and dose interruptions.
Figuras y tablas -
Analysis 2.33

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 33 Dose adjustments and dose interruptions.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 34 Dose interruptions (interrupted at least once).
Figuras y tablas -
Analysis 2.34

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 34 Dose interruptions (interrupted at least once).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 35 Dose reduction (at least once).
Figuras y tablas -
Analysis 2.35

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 35 Dose reduction (at least once).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 36 Dose adjustments (# participants affected).
Figuras y tablas -
Analysis 2.36

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 36 Dose adjustments (# participants affected).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 37 Dose interruptions due to an AE (# participants affected).
Figuras y tablas -
Analysis 2.37

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 37 Dose interruptions due to an AE (# participants affected).

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 38 Haemoglobin (g/dL): mean change from baseline and at end of study.
Figuras y tablas -
Analysis 2.38

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 38 Haemoglobin (g/dL): mean change from baseline and at end of study.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 39 Transfusion index (mL/kg/year): mean at end of study.
Figuras y tablas -
Analysis 2.39

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 39 Transfusion index (mL/kg/year): mean at end of study.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 40 Transferrin saturation (%): mean at end of study.
Figuras y tablas -
Analysis 2.40

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 40 Transferrin saturation (%): mean at end of study.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 41 Platelet count (x10³/mm³): mean at end of study.
Figuras y tablas -
Analysis 2.41

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 41 Platelet count (x10³/mm³): mean at end of study.

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Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 42 Absolute neutrophilic count (/mm³): mean at end of study.
Figuras y tablas -
Analysis 2.42

Comparison 2 Transfusion‐dependent thalassemia: deferasirox vs deferoxamine, Outcome 42 Absolute neutrophilic count (/mm³): mean at end of study.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 1 Mortality at any time point.
Figuras y tablas -
Analysis 3.1

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 1 Mortality at any time point.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 2 Incidence of thyroid disease at end of study.
Figuras y tablas -
Analysis 3.2

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 2 Incidence of thyroid disease at end of study.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 3 ALT (U/L): mean change from baseline.
Figuras y tablas -
Analysis 3.3

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 3 ALT (U/L): mean change from baseline.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 4 AST (U/L): mean change from baseline.
Figuras y tablas -
Analysis 3.4

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 4 AST (U/L): mean change from baseline.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 5 Urea (mg/dL): mean change from baseline.
Figuras y tablas -
Analysis 3.5

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 5 Urea (mg/dL): mean change from baseline.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 6 Creatinine (mg/dL): mean change from baseline.
Figuras y tablas -
Analysis 3.6

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 6 Creatinine (mg/dL): mean change from baseline.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 7 Neutrophil (count per mm³): mean change from baseline.
Figuras y tablas -
Analysis 3.7

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 7 Neutrophil (count per mm³): mean change from baseline.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 8 Serum ferritin (ng/mL): mean change from baseline and at end of study.
Figuras y tablas -
Analysis 3.8

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 8 Serum ferritin (ng/mL): mean change from baseline and at end of study.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 9 LIC (mg/g) evaluated by MRI (R2*): mean change from baseline.
Figuras y tablas -
Analysis 3.9

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 9 LIC (mg/g) evaluated by MRI (R2*): mean change from baseline.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 10 Myocardial T2* (ms): mean change from baseline.
Figuras y tablas -
Analysis 3.10

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 10 Myocardial T2* (ms): mean change from baseline.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 11 Any AE (# participants affected).
Figuras y tablas -
Analysis 3.11

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 11 Any AE (# participants affected).

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 12 AEs.
Figuras y tablas -
Analysis 3.12

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 12 AEs.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 13 Discontinuations (# participants affected).
Figuras y tablas -
Analysis 3.13

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 13 Discontinuations (# participants affected).

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 14 Discontinuation due to an AE (# participants affected).
Figuras y tablas -
Analysis 3.14

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 14 Discontinuation due to an AE (# participants affected).

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 15 Transferrin saturation (%): mean at end of study.
Figuras y tablas -
Analysis 3.15

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 15 Transferrin saturation (%): mean at end of study.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 16 Haemoglobin (g/dL): mean at end of study.
Figuras y tablas -
Analysis 3.16

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 16 Haemoglobin (g/dL): mean at end of study.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 17 Transfusion index (mL/kg/year): mean at end of study.
Figuras y tablas -
Analysis 3.17

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 17 Transfusion index (mL/kg/year): mean at end of study.

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Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 18 ALP (U/L): mean change from baseline.
Figuras y tablas -
Analysis 3.18

Comparison 3 Transfusion‐dependent thalassemia: deferasirox vs deferiprone, Outcome 18 ALP (U/L): mean change from baseline.

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Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 1 Mortality at any time point.
Figuras y tablas -
Analysis 6.1

Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 1 Mortality at any time point.

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Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 2 Neutrophil (µg/L): mean at end of study.
Figuras y tablas -
Analysis 6.2

Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 2 Neutrophil (µg/L): mean at end of study.

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Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 3 ALT (g/dL): mean at end of study.
Figuras y tablas -
Analysis 6.3

Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 3 ALT (g/dL): mean at end of study.

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Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 4 AST (g/dL): mean at end of study.
Figuras y tablas -
Analysis 6.4

Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 4 AST (g/dL): mean at end of study.

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Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 5 Serum ferritin: mean at end of study (ng/mL).
Figuras y tablas -
Analysis 6.5

Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 5 Serum ferritin: mean at end of study (ng/mL).

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Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 6 Discontinuations.
Figuras y tablas -
Analysis 6.6

Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 6 Discontinuations.

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Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 7 Haemoglobin (g/dL): mean at end of study.
Figuras y tablas -
Analysis 6.7

Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 7 Haemoglobin (g/dL): mean at end of study.

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Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 8 ALP (g/dL): mean at end of study.
Figuras y tablas -
Analysis 6.8

Comparison 6 Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine, Outcome 8 ALP (g/dL): mean at end of study.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 1 Mortality at any time point.
Figuras y tablas -
Analysis 7.1

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 1 Mortality at any time point.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 2 Serum ferritin (ng/mL): mean change from baseline.
Figuras y tablas -
Analysis 7.2

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 2 Serum ferritin (ng/mL): mean change from baseline.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 3 LIC (mg/g) evaluated by MRI (R2*): mean change from baseline.
Figuras y tablas -
Analysis 7.3

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 3 LIC (mg/g) evaluated by MRI (R2*): mean change from baseline.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 4 Myocardial T2* (ms): mean change from baseline.
Figuras y tablas -
Analysis 7.4

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 4 Myocardial T2* (ms): mean change from baseline.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 5 Serious AE (# participants affected).
Figuras y tablas -
Analysis 7.5

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 5 Serious AE (# participants affected).

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 6 Serious drug‐related AE (# participants affected).
Figuras y tablas -
Analysis 7.6

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 6 Serious drug‐related AE (# participants affected).

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 7 Serious non‐related drug AE.
Figuras y tablas -
Analysis 7.7

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 7 Serious non‐related drug AE.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 8 AEs.
Figuras y tablas -
Analysis 7.8

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 8 AEs.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 9 Drug‐related AEs (# participants affected).
Figuras y tablas -
Analysis 7.9

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 9 Drug‐related AEs (# participants affected).

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 10 Drug‐related AEs.
Figuras y tablas -
Analysis 7.10

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 10 Drug‐related AEs.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 11 Non‐related drug AEs (# participants affected).
Figuras y tablas -
Analysis 7.11

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 11 Non‐related drug AEs (# participants affected).

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 12 Non‐related drug AEs.
Figuras y tablas -
Analysis 7.12

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 12 Non‐related drug AEs.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 13 Mild elevation of hepatic transaminases at start of therapy (# participants affected).
Figuras y tablas -
Analysis 7.13

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 13 Mild elevation of hepatic transaminases at start of therapy (# participants affected).

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 14 Initial gastrointestinal manifestations (# participants affected).
Figuras y tablas -
Analysis 7.14

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 14 Initial gastrointestinal manifestations (# participants affected).

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 15 Quality of life (%) (measured by SF‐36): mean change from baseline.
Figuras y tablas -
Analysis 7.15

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 15 Quality of life (%) (measured by SF‐36): mean change from baseline.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 16 Adherence: actual dose/total prescribed dose.
Figuras y tablas -
Analysis 7.16

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 16 Adherence: actual dose/total prescribed dose.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 17 Discontinuations.
Figuras y tablas -
Analysis 7.17

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 17 Discontinuations.

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Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 18 Serious AE resulting in study discontinuation or interruption.
Figuras y tablas -
Analysis 7.18

Comparison 7 Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine, Outcome 18 Serious AE resulting in study discontinuation or interruption.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 1 Mortality at any time point.
Figuras y tablas -
Analysis 8.1

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 1 Mortality at any time point.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 2 Serum ferritin (ng/mL): mean change from baseline.
Figuras y tablas -
Analysis 8.2

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 2 Serum ferritin (ng/mL): mean change from baseline.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 3 LIC (mg Fe/g dw) evaluated by MRI R2: least squares mean change from baseline.
Figuras y tablas -
Analysis 8.3

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 3 LIC (mg Fe/g dw) evaluated by MRI R2: least squares mean change from baseline.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 4 LIC (mg Fe/g dw) evaluated by MRI R2: mean change from baseline.
Figuras y tablas -
Analysis 8.4

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 4 LIC (mg Fe/g dw) evaluated by MRI R2: mean change from baseline.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 5 LIC: decrease of ≥ 3 mg Fe/g dw (# participants affected).
Figuras y tablas -
Analysis 8.5

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 5 LIC: decrease of ≥ 3 mg Fe/g dw (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 6 LIC: ≥ 30% reduction Fe/g dw (# participants affected).
Figuras y tablas -
Analysis 8.6

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 6 LIC: ≥ 30% reduction Fe/g dw (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 7 LIC: shift to lower iron burden range (# participants affected).
Figuras y tablas -
Analysis 8.7

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 7 LIC: shift to lower iron burden range (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 8 LIC: achieve LIC < 5 mg Fe/g dw (# participants affected).
Figuras y tablas -
Analysis 8.8

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 8 LIC: achieve LIC < 5 mg Fe/g dw (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 9 Drug‐related serious AEs (# participants affected).
Figuras y tablas -
Analysis 8.9

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 9 Drug‐related serious AEs (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 10 Drug‐related serious AEs (# participants affected).
Figuras y tablas -
Analysis 8.10

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 10 Drug‐related serious AEs (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 11 Any AE (# participants affected).
Figuras y tablas -
Analysis 8.11

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 11 Any AE (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 12 Mild AE (# participants affected).
Figuras y tablas -
Analysis 8.12

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 12 Mild AE (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 13 Moderate AE (# participants affected).
Figuras y tablas -
Analysis 8.13

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 13 Moderate AE (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 14 Severe AE (# participants affected).
Figuras y tablas -
Analysis 8.14

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 14 Severe AE (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 15 AEs.
Figuras y tablas -
Analysis 8.15

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 15 AEs.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 16 Drug‐related AEs.
Figuras y tablas -
Analysis 8.16

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 16 Drug‐related AEs.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 17 Adherence (# participants taking the planned study dose).
Figuras y tablas -
Analysis 8.17

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 17 Adherence (# participants taking the planned study dose).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 18 Discontinuations.
Figuras y tablas -
Analysis 8.18

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 18 Discontinuations.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 19 Discontinuing study due to AE (# participants affected).
Figuras y tablas -
Analysis 8.19

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 19 Discontinuing study due to AE (# participants affected).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 20 Dose increase.
Figuras y tablas -
Analysis 8.20

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 20 Dose increase.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 21 Dose interruption (at least once).
Figuras y tablas -
Analysis 8.21

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 21 Dose interruption (at least once).

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 22 Dose reduction.
Figuras y tablas -
Analysis 8.22

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 22 Dose reduction.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 23 Dose reduction due to AE.
Figuras y tablas -
Analysis 8.23

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 23 Dose reduction due to AE.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 24 Haemoglobin (g/L): mean change from baseline.
Figuras y tablas -
Analysis 8.24

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 24 Haemoglobin (g/L): mean change from baseline.

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Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 25 Transferrin saturation (%): mean change from baseline.
Figuras y tablas -
Analysis 8.25

Comparison 8 Non‐transfusion‐dependent thalassemia: deferasirox vs placebo, Outcome 25 Transferrin saturation (%): mean change from baseline.

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Summary of findings for the main comparison. Deferasirox compared to deferoxamine in people with transfusion‐dependent thalassemia

Deferasirox compared to deferoxamine in people with transfusion‐dependent thalassemia

Patient or population: people with transfusion‐dependent thalassemia
Setting: outpatient care
Intervention: deferasirox
Comparison: deferoxamine

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with deferoxamine

Risk with deferasirox

Mortality at any time point

Study population

RR 0.48
(0.09 to 2.63)

1170
(8 RCTs)

⊕⊕⊝⊝
LOW 1 2

7 per 1.000

3 per 1.000
(1 to 18)

Responder analysis II (responder: LIC 1 to less than 7 mg Fe/g dw)

Study population

RR 0.80
(0.69 to 0.92)

553
(1 RCT)

⊕⊕⊕⊝
MODERATE 1 3 4

664 per 1.000

531 per 1.000
(458 to 611)

Serum ferritin (ng/mL): mean change from baseline and at end of study

MD 454.42 higher
(337.13 higher to 571.71 higher)

‐

1002
(6 RCTs) 5

⊕⊕⊕⊝
MODERATE 1 3 4

LIC (mg Fe/g dw) evaluated by biopsy or SQUID: mean change from baseline

MD 2.37 higher
(1.68 higher to 3.07 higher)

‐

541
(1 RCT)

⊕⊕⊕⊝
MODERATE 1 3 4

Satisfaction with treatment (very satisfied or satisfied): participants previously treated with DFO
assessed with: questionnaire
follow up: mean 52 weeks

Study population

RR 2.20
(1.89 to 2.57)

571
(1 RCT)

⊕⊕⊕⊝
MODERATE 1

1.330 per 1.000

1000 per 1.000
(1.000 to 1.000)

Adherence: discontinuations

Study population

RR 0.95
(0.60 to 1.50)

1211
(8 RCTs)

⊕⊕⊝⊝
LOW 1 6

54 per 1.000

52 per 1.000
(33 to 82)

AE: investigations ‐ isolated serum creatinine increase above ULN

Study population

RR 2.57
(1.88 to 3.51)

657
(2 RCTs)

⊕⊕⊝⊝
LOW 1 7

137 per 1.000

353 per 1.000
(258 to 482)

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AE: adverse events; CI: confidence interval; DFO:deferiprone; dw: dry weight; FE: iron LIC: liver iron concentration; MD: mean difference; RR: risk ratio; SQUID: superconducting quantum interference device; ULN: upper limit of normal.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Serious risk of bias: studies that carry large weight for the overall effect estimate rated as high risk of bias due to lack of blinding and selective reporting.
2 Serious imprecision: wide confidence interval including both clinically relevant benefit as well as harm.
3 Serious inconsistency: differing ratio of drugs between subgroups of one study.
4 Upgrade due to dose‐response gradient: observed for both drugs. Effects therefore depending on ratio of drugs used in comparisons.
5 A sensitivity analysis without the results from four studies which were calculated according to Wan 2014 showed similar results.
6 Serious imprecision: Wide confidence interval, including less discontinuations with deferoxamine treatment.
7 Serious indirectness: Surrogate of creatinine used for patient‐important outcome of kidney failure.

Figuras y tablas -
Summary of findings for the main comparison. Deferasirox compared to deferoxamine in people with transfusion‐dependent thalassemia
Ir a la tabla de la revisión
Summary of findings 2. Deferasirox compared to deferiprone in people with transfusion‐dependent thalassemia

Deferasirox compared to deferiprone in people with transfusion‐dependent thalassemia

Patient or population:people with transfusion‐dependent thalassemia
Setting: outpatient care
Intervention: deferasirox
Comparison: deferiprone

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with deferiprone

Risk with deferasirox

Mortality at any time point

Study population

not estimable

146
(3 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2

0 per 1.000

0 per 1.000
(0 to 0)

Responder analysis

Not measured

NA

Serum ferritin (ng/mL): mean change from baseline and at end of study

MD 229.99 ng/mL higher
(403.14 lower to 863.11 higher)

‐

83
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 3 4

LIC (mg/g) evaluated by MRI R2*: mean change from baseline

MD 0.8 mg/g lower
(2.75 lower to 1.15 higher)

‐

45
(1 RCT)

⊕⊝⊝⊝
VERY LOW 3 4

Satisfaction

Not measured

NA

Adherence: discontinuations

Study population

RR 0.16
(0.01 to 2.99)

179
(3 RCTs)

⊕⊕⊝⊝
LOW 2 5

32 per 1.000

5 per 1.000
(0 to 95)

Renal failure

Study population

not estimable

38
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 6

0 per 1.000

0 per 1.000
(0 to 0)

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; LIC: liver iron concentration; MD: mean difference; MRI: magnetic resonance imaging; NA: not applicable RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Very serious imprecision: only very few number of included participants.
2 Serious risk of bias: selective reporting: Results from Elalfy 2015a for 60 participants not reported.
3 Serious risk of bias: no blinding assumed, selective reporting: Results from Elalfy 2015a for 60 participants not reported.
4 Very serious imprecision: very wide confidence interval including both relevant benefit as well as harm.
5 Serious imprecision: wide CIs including both benefit as well as harm.
6 Serious risk of bias: no blinding assumed.

Figuras y tablas -
Summary of findings 2. Deferasirox compared to deferiprone in people with transfusion‐dependent thalassemia
Ir a la tabla de la revisión
Summary of findings 3. Deferasirox alone compared to combined deferasirox and deferiprone in people with transfusion‐dependent thalassemia

Deferasirox alone compared to combined deferasirox and deferiprone in people with transfusion‐dependent thalassaemia

Patient or population: people with transfusion‐dependent thalassaemia
Setting: outpatient care
Intervention: deferasirox
Comparison: deferasirox and deferiprone

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with deferasirox and deferiprone

Risk with deferasirox

Mortality at any time point

Not reported1

NA

Responder analysis

Not measured1

NA

Serum ferritin (ng/mL)

Not reported1

NA

LIC (mg Fe/g dry weight)

Not reported1

NA

Satisfaction with treatment

Not measured1

NA

Adherence

Not reported1

NA

AE: serum creatinine increase

Not measured1

NA

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AE: adverse events; CI: confidence interval; LIC: liver iron concentration; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 One RCT (40 participants) contributed to this comparison, but no relevant outcome data to this table are available (Kakkar 2014).

Figuras y tablas -
Summary of findings 3. Deferasirox alone compared to combined deferasirox and deferiprone in people with transfusion‐dependent thalassemia
Ir a la tabla de la revisión
Summary of findings 4. Combined deferasirox and deferiprone compared to deferiprone alone in people with transfusion‐dependent thalassemia

Combined deferasirox and deferiprone compared to deferiprone alone in people with transfusion‐dependent thalassaemia

Patient or population: people with transfusion‐dependent thalassemia
Setting: outpatient care
Intervention: deferasirox and deferiprone
Comparison: deferiprone

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with deferasirox and deferiprone

Risk with deferasirox

Mortality at any time point

Not reported1

NA

Responder analysis

Not measured1

NA

Serum ferritin (ng/mL)

Not reported1

NA

LIC (mg Fe/g dry weight)

Not reported1

NA

Satisfaction with treatment

Not measured1

NA

Adherence

Not reported1

NA

AE: Serum creatinine increase

Not measured1

NA

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AE: adverse events; CI: confidence interval; LIC: liver iron concentration; MD: mean difference; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 One RCT (40 participants) contributed to this comparison, but no relevant outcome data to this table are available (Kakkar 2014).

Figuras y tablas -
Summary of findings 4. Combined deferasirox and deferiprone compared to deferiprone alone in people with transfusion‐dependent thalassemia
Ir a la tabla de la revisión
Summary of findings 5. Deferasirox and deferoxamine compared to deferoxamine in people with transfusion‐dependent thalassemia

Deferasirox and deferoxamine compared to deferoxamine in people with transfusion‐dependent thalassemia

Patient or population: people with transfusion‐dependent thalassemia
Setting:outpatient care
Intervention: deferasirox and deferoxamine
Comparison: deferoxamine

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with deferoxamine

Risk with deferasirox and deferoxamine

Mortality at any time point

Study population

not estimable

94
(1 RCT)

⊕⊕⊝⊝
LOW 1

0 per 1.000

0 per 1.000
(0 to 0)

Responder analysis

Not measured

NA

Serum ferritin (ng/mL) ‐ mean at end of study

MD 87.84 ng/mL higher
(612.23 lower to 787.91 higher)

‐

94
(1 RCT)

⊕⊝⊝⊝
VERY LOW 2 3

LIC

Not measured

NA

Satisfaction with treatment

Not measured

NA

Adherence: Discontinuations

Study population

not estimable

94
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 2

0 per 1.000

0 per 1.000
(0 to 0)

AE: serum creatinine increased

Not reported

NA

Serum creatinine was measured in Molavi 2014, but no results were reported.

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AE: adverse events; CI: confidence interval; LIC: liver iron concentration; MD: mean difference; NA: not applicable; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Very serious imprecision: only very few participants included.
2 Serious risk of bias: assumed lack of blinding.
3 Very serious imprecision: very wide confidence interval including both benefit as well as harm.

Figuras y tablas -
Summary of findings 5. Deferasirox and deferoxamine compared to deferoxamine in people with transfusion‐dependent thalassemia
Ir a la tabla de la revisión
Summary of findings 6. Deferasirox and deferiprone compared to deferiprone and deferoxamine in people with transfusion‐dependent thalassemia

Deferasirox and deferiprone compared to deferiprone and deferoxamine in people with transfusion‐dependent thalassemia

Patient or population: people with transfusion‐dependent thalassemia
Setting: outpatient care
Intervention: deferasirox and deferiprone
Comparison: deferiprone and deferoxamine

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with deferiprone and deferoxamine

Risk with deferasirox and deferiprone

Mortality at any time point

Study population

not estimable

96
(1 RCT)

⊕⊕⊝⊝
LOW 1

"All the included patients continued till the end of study with no patients were lost follow‐up." (Elalfy 2015b)

0 per 1.000

0 per 1.000
(0 to 0)

Responder analysis

Not measured

NA

Serum ferritin (ng/mL): mean change from baseline

MD 315.9 ng/mL lower
(1046.26 lower to 414.46 higher)

‐

96
(1 RCT)

⊕⊝⊝⊝
VERY LOW 2 3

LIC evaluated by MRI R2*: mean change from baseline

MD 0.62 mg/g lower
(2.25 lower to 1.01 higher)

‐

96
(1 RCT)

⊕⊕⊝⊝
LOW 2 4

Satisfaction

Not reported

NA

"Compared to baseline, patient‐reported satisfaction associated with ICT was significantly higher in group B [DFX and DFP] compared to group A [DFP and DFO] (p<0.01)" (Elalfy 2015b)

Adherence: Discontinuations

Study population

not estimable

96
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 2

0 per 1.000

0 per 1.000
(0 to 0)

Drug‐related AE: serum creatinine increased (≥ 33%) above baseline in 2 consecutive occasions

Study population

RR 3.00
(0.32 to 27.83)

96
(1 RCT)

⊕⊝⊝⊝
VERY LOW 2 3 5

21 per 1.000

63 per 1.000
(7 to 580)

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AE: adverse events; CI: confidence interval; LIC: liver iron concentration; MD: mean difference; MRI: magnetic resonance imaging; NA: not applicable; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Very serious imprecision: very few participants included.
2 Serious risk of bias: no blinding, selective reporting: no data for 18 months follow‐up.
3 Very serious imprecision: very wide confidence interval including both benefit as well as harm.
4 Serious imprecision: wide confidence interval including both benefit as well as harm.
5 Serious indirectness: surrogate of creatinine used for patient‐important outcome of kidney failure.

Figuras y tablas -
Summary of findings 6. Deferasirox and deferiprone compared to deferiprone and deferoxamine in people with transfusion‐dependent thalassemia
Ir a la tabla de la revisión
Summary of findings 7. Deferasirox compared to placebo in people with non‐transfusion‐dependent thalassemia

Deferasirox compared to placebo in people with non‐transfusion‐dependent thalassemia

Patient or population: people with non‐transfusion‐dependent thalassemia
Setting: outpatient care
Intervention: deferasirox
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo

Risk with deferasirox

Mortality at any time point

Study population

not estimable

148
(1 RCT)

⊕⊕⊕⊝
MODERATE 1

"No deaths occurred during the study in any group" (Taher 2012)

0 per 1.000

0 per 1.000
(0 to 0)

Responder analysis

Not measured

NA

Serum ferritin (ng/mL): mean change from baseline

MD 306.74 ng/mL lower
(398.23 lower to 215.24 lower)

‐

154
(1 RCT)

⊕⊕⊕⊝
MODERATE 1

LIC (mg Fe/g dry weight) evaluated by MRI R2: least squares mean change from baseline

MD 3.27 mg Fe/g dry weight lower
(4.44 lower to 2.09 lower)

‐

159
(1 RCT)

⊕⊕⊕⊝
MODERATE 1

Satisfaction with treatment

Not measured

NA

Adherence: Discontinuations

Study population

RR 1.32
(0.50 to 3.52)

166
(1 RCT)

⊕⊕⊝⊝
LOW 2

89 per 1.000

118 per 1.000
(45 to 314)

AE: abnormal serum creatinine (post‐baseline)

Study population

RR 3.59
(0.19 to 68.40)

166
(1 RCT)

⊕⊝⊝⊝
VERY LOW 2 3

0 per 1.000

0 per 1.000
(0 to 0)

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AE: adverse events; CI: confidence interval; LIC: liver iron concentration; MD: mean difference; NA: not applicable; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Serious imprecision: only few patients included.
2 Very serious imprecision: very wide confidence interval, including both benefit as well as harm.
3 Serious indirectness: surrogate of creatinine used for patient‐important outcome of kidney failure.

Figuras y tablas -
Summary of findings 7. Deferasirox compared to placebo in people with non‐transfusion‐dependent thalassemia
Ir a la tabla de la revisión
Comparison 1. Transfusion‐dependent thalassemia: deferasirox vs placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality at any time point Show forest plot

2

47

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 AEs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 Eye disorders ‐ retinal infarct

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 GI disorders ‐ abdominal pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 GI disorders ‐ diarrhoea

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 GI disorders ‐ nausea

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.5 Investigations ‐ extended QT interval, hypocalcaemia, hypoparathyroidism

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.6 Skin and subcutaneous tissue disorders ‐ rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Discontinuations due to serious AEs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Transfusion‐dependent thalassemia: deferasirox vs placebo
Ir a la tabla de la revisión
Comparison 2. Transfusion‐dependent thalassemia: deferasirox vs deferoxamine

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality at any time point Show forest plot

8

1170

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.09, 2.63]

1.1 At 8 months

1

138

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 At 48 weeks (deferasirox 10 mg/kg/day)

1

35

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 At 48 weeks (deferasirox 20 mg/kg/day )

1

36

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 At 1 year

5

942

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.09, 2.63]

1.5 At 2 years

1

19

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 LVEF (%): least squares mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3 LVEF (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Improvement from abnormal LVEF to normal range

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Decrease from normal LVEF to below LLN

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Incidence of thyroid disease at end of study Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

5 ALT (# participants affected): improvement from abnormal to normal range Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6 ALT (U/L) at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

7 AST (U/L) at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

8 Serum creatinine (mg/dL) at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

9 Blood urea (mg/dL): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

10 Serum ferritin (ng/mL): mean change from baseline and at end of study Show forest plot

6

1002

Mean Difference (IV, Fixed, 95% CI)

454.42 [337.13, 571.71]

10.1 Less than 3 mg Fe/g dw (median 5 mg deferasirox / 30mg deferoxamine)

1

28

Mean Difference (IV, Fixed, 95% CI)

978.0 [544.71, 1411.29]

10.2 More than 3 to 7 mg Fe/g dw (10/35)

1

150

Mean Difference (IV, Fixed, 95% CI)

801.0 [572.53, 1029.47]

10.3 More than 7 mg Fe/g dw (20/41)

1

169

Mean Difference (IV, Fixed, 95% CI)

328.0 [124.94, 531.06]

10.4 More than 14 mg Fe/g dw (30/51)

1

216

Mean Difference (IV, Fixed, 95% CI)

77.0 [‐303.18, 457.18]

10.5 Any iron overload

5

439

Mean Difference (IV, Fixed, 95% CI)

234.25 [‐8.02, 476.52]

11 Sensitivity analysis: serum ferritin (ng/mL): mean change from baseline Show forest plot

2

701

Mean Difference (IV, Fixed, 95% CI)

418.94 [297.23, 540.65]

11.1 Less than 3 mg Fe/g dw (median 5 mg deferasirox / 30 mg deferoxamine)

1

28

Mean Difference (IV, Fixed, 95% CI)

978.0 [544.71, 1411.29]

11.2 More than 3 to 7 mg Fe/g dw (10/35)

1

150

Mean Difference (IV, Fixed, 95% CI)

801.0 [572.53, 1029.47]

11.3 More than 7 mg Fe/g dw (20/41)

1

169

Mean Difference (IV, Fixed, 95% CI)

328.0 [124.94, 531.06]

11.4 More than 14 mg Fe/g dw (30/51)

1

216

Mean Difference (IV, Fixed, 95% CI)

77.0 [‐303.18, 457.18]

11.5 Any iron overload

1

138

Mean Difference (IV, Fixed, 95% CI)

‐64.16 [‐354.62, 226.30]

12 Liver R2* (Hz): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

13 LIC (mg/g) evaluated by MRI (R2/R2*): mean change from baseline Show forest plot

2

217

Mean Difference (IV, Fixed, 95% CI)

0.36 [‐1.01, 1.72]

14 LIC (mg Fe/g dw) evaluated by biopsy or SQUID: mean change from baseline Show forest plot

1

541

Mean Difference (IV, Fixed, 95% CI)

2.37 [1.68, 3.07]

14.1 LIC 3 mg Fe/g dw or less (5/30)

1

28

Mean Difference (IV, Fixed, 95% CI)

4.3 [2.30, 6.30]

14.2 LIC more than 3 mg to 7 mg (10/35) Fe/g dw

1

143

Mean Difference (IV, Fixed, 95% CI)

3.80 [2.74, 4.86]

14.3 LIC more than 7 mg to 14 mg Fe/g dw (20/41)

1

164

Mean Difference (IV, Fixed, 95% CI)

1.5 [0.28, 2.72]

14.4 LIC more than 14 mg Fe/g dw (30/51)

1

206

Mean Difference (IV, Fixed, 95% CI)

‐2.5 [‐4.55, ‐0.45]

15 Responder analysis I (responder: fall in LIC > 10%) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

15.1 Response at 48 weeks (deferasirox 10 mg/kg/day)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.2 Response at 48 weeks (deferasirox 20 mg/kg/day)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

16 Responder analysis II (responder: LIC 1 to < 7 mg Fe/g dw) Show forest plot

1

553

Risk Ratio (M‐H, Fixed, 95% CI)

0.80 [0.69, 0.92]

16.1 Response at 1 year (LIC below 7 mg Fe/g dw)

1

172

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.37, 0.64]

16.2 Response at 1 year (LIC at least 7 mg Fe/g dw)

1

381

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.84, 1.18]

17 Myocardial T2* (ms): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

18 Myocardial iron concentration derived from T2* value (mg Fe/g dw): change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

18.1 All participants

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.2 Participants with T2* <10 ms

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.3 Participants with T2* ≥10 ms

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

19 Myocardial T2* (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

19.1 Normalization

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

19.2 Improvement (from 6 ‐ < 10 ms to 10 ‐ ≤ 20 ms)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

19.3 Worsening (from 10‐ ≤ 20 ms to 6 ‐ < 10 ms)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

20 Iron excretion‐intake ratio Show forest plot

1

541

Mean Difference (IV, Fixed, 95% CI)

‐0.18 [‐0.24, ‐0.12]

20.1 Less than 3 mg Fe/g dw (median 5 mg deferasirox / 30 mg deferoxamine)

1

28

Mean Difference (IV, Fixed, 95% CI)

‐0.37 [‐0.54, ‐0.20]

20.2 More than 3 to 7 mg Fe/g dw (10/35)

1

143

Mean Difference (IV, Fixed, 95% CI)

‐0.31 [‐0.41, ‐0.21]

20.3 More than 7 mg Fe/g dw (20/41)

1

164

Mean Difference (IV, Fixed, 95% CI)

‐0.11 [‐0.21, ‐0.01]

20.4 More than 14 mg Fe/g dw (30/51)

1

206

Mean Difference (IV, Fixed, 95% CI)

0.23 [0.05, 0.41]

21 Any serious AEs (# participants affected) Show forest plot

2

773

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.42, 1.86]

22 Serious AEs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

22.1 Cardiac disorders ‐ arrhythmia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.2 Endocrine disorders ‐ hypogonadism

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.3 GI disorders abdominal abscess

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.4 GI disorders amoebiasis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.5 GI disorders ‐ appendicitis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.6 GI disorders ‐ colitis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.7 GI disorders ‐ diarrhoea

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.8 GI disorders ‐ gastric haemorrhage

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.9 GI disorders ‐ gastroenteritis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.10 GI disorders ‐ ileus

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.11 GI disorders ‐ upper abdominal pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.12 GI disorders ‐ vomiting

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.13 GI disorders ‐ GI infection

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.14 General disorders and administration site conditions ‐ pyrexia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.15 General disorders and administration site conditions ‐ local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.16 Hepatobiliary disorders ‐ liver abscess

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.17 Hepatobiliary disorders ‐ cholelithiasis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.18 Immune system disorders ‐ face oedema

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.19 Infections and infestations ‐ herpes zoster

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.20 Infections and infestations ‐ tooth infection

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.21 Infections and infestations ‐ urinary tract infection

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.22 Injury, poisoning and procedural complications ‐ oesophageal rupture

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.23 Injury, poisoning and procedural complications ‐ haemosiderosis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.24 Injury, poisoning and procedural complications ‐ iron overload

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.25 Metabolism and nutrition disorders ‐ hyperglycaemia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.26 Musculoskeletal and connective tissue disorders ‐ back pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.27 Musculoskeletal and connective tissue disorders ‐ pain in jaw

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.28 Nervous system disorders ‐ grand mal convulsion

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.29 Nervous system disorders ‐ meningitis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

22.30 Respiratory, thoracic and mediastinal disorders ‐ acute tonsilitis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

23 Any AE (# participants affected) Show forest plot

2

258

Risk Ratio (M‐H, Fixed, 95% CI)

0.94 [0.83, 1.08]

24 AEs Show forest plot

5

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

24.1 Blood and lymphatic system disorder ‐ agranulocytosis

2

657

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

24.2 Blood and lymphatic system disorder ‐ leukopenia

1

138

Risk Ratio (M‐H, Fixed, 95% CI)

7.0 [0.37, 133.02]

24.3 Blood and lymphatic system disorder ‐ neutropenia

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

24.4 Blood and lymphatic system disorder ‐ thrombocytopenia

2

209

Risk Ratio (M‐H, Fixed, 95% CI)

4.0 [0.46, 34.88]

24.5 Cardiac disorders ‐ cardiac AE

1

586

Risk Ratio (M‐H, Fixed, 95% CI)

0.73 [0.38, 1.41]

24.6 Ear and labyrinth disorders ‐ hearing loss

2

657

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.41, 3.05]

24.7 Eye disorder ‐ lens abnormality

2

657

Risk Ratio (M‐H, Fixed, 95% CI)

0.39 [0.08, 2.00]

24.8 Eye disorder ‐ retinal abnormality

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

24.9 GI disorders ‐ abdominal pain

2

258

Risk Ratio (M‐H, Fixed, 95% CI)

1.69 [0.93, 3.05]

24.10 GI disorders ‐ abdominal pain upper

1

187

Risk Ratio (M‐H, Fixed, 95% CI)

1.14 [0.36, 3.60]

24.11 GI disorders ‐ diarrhoea

2

258

Risk Ratio (M‐H, Fixed, 95% CI)

1.65 [0.86, 3.16]

24.12 GI disorders ‐ dyspepsia

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

1.20 [0.25, 5.72]

24.13 GI disorders ‐ GIT upset

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

3.0 [0.66, 13.69]

24.14 GI disorders ‐ nausea

2

258

Risk Ratio (M‐H, Fixed, 95% CI)

2.59 [0.90, 7.47]

24.15 GI disorders ‐ vomiting

2

258

Risk Ratio (M‐H, Fixed, 95% CI)

2.95 [0.91, 9.55]

24.16 General disorders and administration site conditions ‐ asthenia

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

1.20 [0.42, 3.42]

24.17 General disorders and administration site conditions ‐ influenza‐like illness

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

1.20 [0.42, 3.42]

24.18 General disorders and administration site conditions ‐ pyrexia

2

258

Risk Ratio (M‐H, Fixed, 95% CI)

1.27 [0.66, 2.44]

24.19 Immune system disorders ‐ allergic conjunctivitis

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

4.41 [0.25, 78.58]

24.20 Infections and infestations ‐ bronchitis

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

2.40 [0.30, 19.35]

24.21 Infections and infestations ‐ upper respiratory tract infection

1

187

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.37, 2.42]

24.22 Infections and infestations ‐ urinary tract infection

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

2.40 [0.30, 19.35]

24.23 Investigations ‐ ALT increased

1

187

Risk Ratio (M‐H, Fixed, 95% CI)

1.71 [0.59, 4.90]

24.24 Investigations ‐ elevated ALT (>2 UNL)

1

586

Risk Ratio (M‐H, Fixed, 95% CI)

4.90 [0.24, 101.60]

24.25 Investigations ‐ AST increased

1

187

Risk Ratio (M‐H, Fixed, 95% CI)

2.21 [0.59, 8.29]

24.26 Investigations ‐ blood creatinine increased

1

187

Risk Ratio (M‐H, Fixed, 95% CI)

3.79 [0.83, 17.38]

24.27 Investigations ‐ isolated serum creatinine increase above upper limit of normal

2

657

Risk Ratio (M‐H, Fixed, 95% CI)

2.57 [1.88, 3.51]

24.28 Investigations ‐ platelet count increased

1

187

Risk Ratio (M‐H, Fixed, 95% CI)

0.38 [0.08, 1.91]

24.29 Musculoskeletal and connective tissue disorders ‐ arthralgia

2

258

Risk Ratio (M‐H, Fixed, 95% CI)

1.31 [0.55, 3.13]

24.30 Musculoskeletal and connective tissue disorders ‐ back pain

2

258

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [0.73, 2.34]

24.31 Musculoskeletal and connective tissue disorders ‐ osteoporosis

1

187

Risk Ratio (M‐H, Fixed, 95% CI)

2.37 [0.47, 11.91]

24.32 Nervous system disorders ‐ headache

2

258

Risk Ratio (M‐H, Fixed, 95% CI)

1.44 [0.68, 3.05]

24.33 Nervous system disorders ‐ vertigo

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.32, 3.93]

24.34 Renal and urinary disorders ‐ proteinuria

1

187

Risk Ratio (M‐H, Fixed, 95% CI)

1.16 [0.50, 2.66]

24.35 Respiratory, thoracic and mediastinal disorders ‐ cough

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

1.80 [0.67, 4.81]

24.36 Respiratory, thoracic and mediastinal disorders ‐ influenza

2

258

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.52, 2.13]

24.37 Respiratory, thoracic and mediastinal disorders ‐ nasopharyngitis

1

187

Risk Ratio (M‐H, Fixed, 95% CI)

1.90 [0.59, 6.08]

24.38 Respiratory, thoracic and mediastinal disorders ‐ oropharyngeal pain

1

187

Risk Ratio (M‐H, Fixed, 95% CI)

2.84 [0.59, 13.73]

24.39 Respiratory, thoracic and mediastinal disorders ‐ pharyngitis

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.52, 2.00]

24.40 Respiratory, thoracic and mediastinal disorders ‐ pharyngolaryngeal pain

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.37, 2.08]

24.41 Respiratory, thoracic and mediastinal disorders ‐ rhinitis

1

71

Risk Ratio (M‐H, Fixed, 95% CI)

1.28 [0.58, 2.83]

24.42 Skin and subcutaneous tissue disorders ‐ Rash

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

2.67 [0.78, 9.09]

25 Any drug‐related AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

26 Drug‐related AEs Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

26.1 Blood and lymphatic system disorder ‐ neutropenia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.2 Injury, poisoning and procedural complications ‐ infusion site haemorrhage

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.3 Injury, poisoning and procedural complications ‐ infusion site pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.4 Injury, poisoning and procedural complications ‐ infusion site swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.5 Injury, poisoning and procedural complications ‐ injection site pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.6 Injury, poisoning and procedural complications ‐ injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.7 Investigations ‐ blood creatinine increased

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.8 Investigations ‐ ALT increased

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.9 Investigations ‐ AST increased

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.10 GI disorders ‐ abdominal pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.11 GI disorders ‐ abdominal pain upper

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.12 GI disorders ‐ diarrhoea

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.13 GI disorders ‐ nausea

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.14 GI disorders ‐ vomiting

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.15 Immune system disorders ‐ hypersensitivity

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.16 Immune system disorders ‐ urticaria

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.17 Musculoskeletal and connective tissue disorders ‐ arthropathy

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.18 Renal and urinary disorders ‐ proteinuria

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.19 Skin and subcutaneous tissue disorders ‐ alopecia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.20 Skin and subcutaneous tissue disorders ‐ rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.21 Injury, poisoning and procedural complications ‐ pulmonary toxicity

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.22 Eye disorders ‐ Ophthalmological toxicity

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.23 Ear and labyrinth disorders ‐ Audiological toxicity

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

27 Satisfaction with treatment (very satisfied or satisfied) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

27.1 Week 4 ‐ participants previously treated with DFO

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

27.2 Week 24 ‐ participants previously treated with DFO

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

27.3 End of study (1 year) ‐ participants previously treated with DFO

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

27.4 Week 4 ‐ DFO‐naive participants

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

27.5 Week 24 ‐ DFO‐naive participants

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

27.6 End of study (1 year) ‐ DFO‐naive participants

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

28 Convenience (good or very good) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

28.1 Week 4 ‐ participants previously treated with DFO

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

28.2 Week 24 ‐ participants previously treated with DFO

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

28.3 End of study (1 year) ‐ participants previously treated with DFO

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

28.4 Week 4 ‐ DFO‐naive participants

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

28.5 Week 24 ‐ DFO‐naive participants

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

28.6 End of study (1 year) ‐ DFO‐naive participants

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

29 Willingness to continue treatment Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

29.1 Participants treated previously with DFO

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

29.2 DFO‐naive participants

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

30 Time lost from normal activities due to treatment (hours/month): participants treated previously with DFO Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

30.1 week 4 ‐ patients treated previously with DFO

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

30.2 week 24 ‐ patients treated previously with DFO

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

30.3 end of study (1 year) ‐ patients treated previously with DFO

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

30.4 week 4 ‐ DFO‐naive patients

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

30.5 week 24 ‐ DFO‐naive patients

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

30.6 end of study (1 year) ‐ DFO‐naive patients

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

31 Adherence (% of planned dose) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

32 Discontinuations Show forest plot

8

1211

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.60, 1.50]

32.1 Deferasirox 10 mg/kg/day

1

35

Risk Ratio (M‐H, Fixed, 95% CI)

0.16 [0.01, 3.64]

32.2 Deferasirox 20 mg/kg/day

2

174

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.10, 9.96]

32.3 Deferasirox 25 mg/kg/day

1

120

Risk Ratio (M‐H, Fixed, 95% CI)

0.09 [0.01, 1.61]

32.4 Deferasirox 40 mg/kg/day

2

211

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.51, 2.05]

32.5 Deferasirox ‐ variable dosage

2

646

Risk Ratio (M‐H, Fixed, 95% CI)

1.39 [0.67, 2.85]

32.6 Deferasirox dosing unknown

1

25

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

33 Dose adjustments and dose interruptions Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

34 Dose interruptions (interrupted at least once) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

35 Dose reduction (at least once) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

36 Dose adjustments (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

37 Dose interruptions due to an AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

38 Haemoglobin (g/dL): mean change from baseline and at end of study Show forest plot

2

180

Mean Difference (IV, Fixed, 95% CI)

‐0.52 [‐0.82, ‐0.21]

38.1 At 8 months (change from baseline)

1

138

Mean Difference (IV, Fixed, 95% CI)

‐0.46 [‐0.81, ‐0.11]

38.2 At 1 year (at end of study)

1

42

Mean Difference (IV, Fixed, 95% CI)

‐0.70 [‐1.33, ‐0.07]

39 Transfusion index (mL/kg/year): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

40 Transferrin saturation (%): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

41 Platelet count (x10³/mm³): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

42 Absolute neutrophilic count (/mm³): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 2. Transfusion‐dependent thalassemia: deferasirox vs deferoxamine
Ir a la tabla de la revisión
Comparison 3. Transfusion‐dependent thalassemia: deferasirox vs deferiprone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality at any time point Show forest plot

3

146

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.1 at 1 year

2

128

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 at 2 years

1

18

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Incidence of thyroid disease at end of study Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3 ALT (U/L): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4 AST (U/L): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Urea (mg/dL): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6 Creatinine (mg/dL): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

7 Neutrophil (count per mm³): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

8 Serum ferritin (ng/mL): mean change from baseline and at end of study Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

8.1 All participants

2

83

Mean Difference (IV, Fixed, 95% CI)

229.99 [‐403.14, 863.11]

8.2 Ferritin > 4000

1

11

Mean Difference (IV, Fixed, 95% CI)

1129.0 [‐2226.18, 4484.18]

8.3 Ferritin 2000 ‐ 4000

1

16

Mean Difference (IV, Fixed, 95% CI)

‐151.0 [‐743.80, 441.80]

8.4 Ferritin < 2000

1

11

Mean Difference (IV, Fixed, 95% CI)

388.0 [‐255.71, 1031.71]

9 LIC (mg/g) evaluated by MRI (R2*): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

10 Myocardial T2* (ms): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

11 Any AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

12 AEs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

12.1 GI disorders ‐ diarrhoea

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.2 GI disorders ‐ nausea

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.3 GI disorders ‐ pain abdomen

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.4 GI disorders ‐ vomiting

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.5 Musculoskeletal and connective tissue disorders ‐ arthralgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.6 Skin and subcutaneous tissue disorders ‐ rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.7 Blood and lymphatic system disorder ‐ agranulocytosis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.8 Blood and lymphatic system disorder ‐ neutropenia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.9 Investigations ‐ AST levels > 2x UNL

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.10 Investigations ‐ ALT levels > 2x UNL

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.11 Investigations ‐ serum creatinine 50% increase from baseline

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.12 Renal and urinary disorders ‐ renal failure

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

13 Discontinuations (# participants affected) Show forest plot

3

179

Risk Ratio (M‐H, Fixed, 95% CI)

0.16 [0.01, 2.99]

14 Discontinuation due to an AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

15 Transferrin saturation (%): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

16 Haemoglobin (g/dL): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

17 Transfusion index (mL/kg/year): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

18 ALP (U/L): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 3. Transfusion‐dependent thalassemia: deferasirox vs deferiprone
Ir a la tabla de la revisión
Comparison 6. Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality at any time point Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 at 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Neutrophil (µg/L): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3 ALT (g/dL): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4 AST (g/dL): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Serum ferritin: mean at end of study (ng/mL) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6 Discontinuations Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

7 Haemoglobin (g/dL): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

8 ALP (g/dL): mean at end of study Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 6. Transfusion‐dependent thalassemia: deferasirox + deferoxamine vs deferoxamine
Ir a la tabla de la revisión
Comparison 7. Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality at any time point Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 at 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Serum ferritin (ng/mL): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3 LIC (mg/g) evaluated by MRI (R2*): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4 Myocardial T2* (ms): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Serious AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6 Serious drug‐related AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6.1 Cholecystitis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Serious non‐related drug AE Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

7.1 Appendicitis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 AEs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

8.1 Blood and lymphatic system disorder ‐ agranulocytosis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 Blood and lymphatic system disorder ‐ neutropenia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9 Drug‐related AEs (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

10 Drug‐related AEs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

10.1 Blood and lymphatic system disorders ‐ agranulocytosis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.2 Blood and lymphatic system disorders ‐ neutropenia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.3 GI disorders ‐ GI problems

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.4 Investigations ‐ ALT increase ( ≥ 3 folds)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.5 Investigations ‐ serum creatinine ( ≥ 33%) above baseline in 2 consecutive occasions

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.6 Musculoskeletal and connective tissue disorders ‐ arthralgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.7 Skin and subcutaneous tissue disorders ‐ skin rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

11 Non‐related drug AEs (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

12 Non‐related drug AEs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

12.1 Infections and infestations ‐ infections

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.2 GI disorders

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.3 Skin and subcutaneous tissue disorders

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

13 Mild elevation of hepatic transaminases at start of therapy (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

14 Initial gastrointestinal manifestations (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

15 Quality of life (%) (measured by SF‐36): mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

16 Adherence: actual dose/total prescribed dose Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

17 Discontinuations Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

18 Serious AE resulting in study discontinuation or interruption Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 7. Transfusion‐dependent thalassemia: deferasirox + deferiprone vs deferiprone + deferoxamine
Ir a la tabla de la revisión
Comparison 8. Non‐transfusion‐dependent thalassemia: deferasirox vs placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality at any time point Show forest plot

1

148

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.1 Deferasirox 5 mg/kg/day: at 12 months

1

73

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Deferasirox 10 mg/kg/day: at 12 months

1

75

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Serum ferritin (ng/mL): mean change from baseline Show forest plot

1

154

Mean Difference (IV, Fixed, 95% CI)

‐306.74 [‐398.23, ‐215.24]

2.1 Deferasirox 5 mg/kg/day

1

78

Mean Difference (IV, Fixed, 95% CI)

‐259.1 [‐377.35, ‐140.85]

2.2 Deferasirox 10 mg/kg/day

1

76

Mean Difference (IV, Fixed, 95% CI)

‐377.79 [‐522.21, ‐233.37]

3 LIC (mg Fe/g dw) evaluated by MRI R2: least squares mean change from baseline Show forest plot

1

159

Mean Difference (IV, Fixed, 95% CI)

‐3.27 [‐4.44, ‐2.09]

3.1 Deferasirox 5 mg/kg/day

1

78

Mean Difference (IV, Fixed, 95% CI)

‐2.33 [‐4.00, ‐0.66]

3.2 Deferasirox 10 mg/kg/day

1

81

Mean Difference (IV, Fixed, 95% CI)

‐4.18 [‐5.83, ‐2.53]

4 LIC (mg Fe/g dw) evaluated by MRI R2: mean change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4.1 Non‐transfusion‐dependent β‐thalassemia 5 mg/kg/day

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Non‐transfusion‐dependent β‐thalassemia 10 mg/kg/day

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 α‐thalassemia 5 mg/kg/day

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 α‐thalassemia 10 mg/kg/day

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.5 HbE/β‐thalassemia 5 mg/kg/day

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.6 HbE/β‐thalassemia 10 mg/kg/day

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.7 < 18 years 5 mg/kg/day

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.8 < 18 years 10 mg/kg/day

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.9 ≥18 years 5 mg/kg/day

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.10 ≥18 years 10 mg/kg/day

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 LIC: decrease of ≥ 3 mg Fe/g dw (# participants affected) Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

4.16 [1.90, 9.11]

5.1 Deferasirox 5 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

3.05 [0.98, 9.50]

5.2 Deferasirox 10 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

5.26 [1.76, 15.71]

6 LIC: ≥ 30% reduction Fe/g dw (# participants affected) Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

14.17 [2.88, 69.74]

6.1 Deferasirox 5 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

15.02 [0.93, 242.87]

6.2 Deferasirox 10 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

13.75 [1.97, 95.97]

7 LIC: shift to lower iron burden range (# participants affected) Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

3.35 [1.62, 6.91]

7.1 Deferasirox 5 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

3.39 [1.10, 10.45]

7.2 Deferasirox 10 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

3.31 [1.28, 8.55]

8 LIC: achieve LIC < 5 mg Fe/g dw (# participants affected) Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

5.35 [1.30, 21.99]

8.1 deferasirox 5mg/kg/d

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

4.07 [0.54, 30.96]

8.2 deferasirox 10mg/kg/d

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

6.62 [0.91, 48.05]

9 Drug‐related serious AEs (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

10 Drug‐related serious AEs (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

10.1 GI disorders ‐ abdominal pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.2 Infections and infestations ‐ cellulitis

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.3 Skin and subcutaneous tissue disorders ‐ pruritus

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.4 Skin and subcutaneous tissue disorders ‐ rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.5 General disorders ‐ pyrexia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.6 Hepatobiliary disorders ‐ hepatotoxicity

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

11 Any AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

12 Mild AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

13 Moderate AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

14 Severe AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

15 AEs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

15.1 Ear and labyrinth disorders ‐ neurosensory deafness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.2 Investigations ‐ abnormal platelet count (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.3 Investigations ‐ abnormal neutrophils count (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.4 Investigations ‐ abnormal ALT (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.5 Investigations ‐ abnormal AST (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.6 Investigations ‐ abnormal serum creatinine (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.7 Investigations ‐ abnormal creatinine clearance (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.8 Investigations ‐ urinary protein/creatinine ratio (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.9 Investigations ‐ abnormal (low) systolic blood pressure (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.10 Investigations ‐ abnormal (high) systolic blood pressure (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.11 Investigations ‐ abnormal (low) diastolic blood pressure (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.12 Investigations ‐ abnormal (high) diastolic blood pressure (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.13 Investigations ‐ abnormal (low) pulse rate (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.14 Investigations ‐ abnormal (high) pulse rate (post‐baseline)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.15 Renal and urinary disorders ‐ proteinuria

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

16 Drug‐related AEs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

16.1 GI disorders ‐ abdominal pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.2 GI disorders ‐ abdominal pain upper

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.3 GI disorders ‐ diarrhoea

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.4 GI disorders ‐ nausea

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.5 Nervous system disorders ‐ headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.6 Skin and subcutaneous tissue disorders ‐ skin rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

17 Adherence (# participants taking the planned study dose) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

18 Discontinuations Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

1.32 [0.50, 3.52]

18.1 Deferasirox 5 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

1.19 [0.33, 4.25]

18.2 Deferasirox 10 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

1.53 [0.33, 7.08]

19 Discontinuing study due to AE (# participants affected) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

20 Dose increase Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.63, 1.19]

20.1 Deferasirox 5 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.57, 1.38]

20.2 Deferasirox 10 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

0.85 [0.54, 1.33]

21 Dose interruption (at least once) Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

1.10 [0.88, 1.39]

21.1 Deferasirox 5 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.73, 1.43]

21.2 Deferasirox 10 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

1.19 [0.87, 1.62]

22 Dose reduction Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

1.46 [0.70, 3.06]

22.1 Deferasirox 5 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

1.53 [0.54, 4.30]

22.2 Deferasirox 10 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

1.4 [0.49, 4.00]

23 Dose reduction due to AE Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

1.53 [0.69, 3.38]

23.1 Deferasirox 5 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

2.04 [0.63, 6.63]

23.2 Deferasirox 10 mg/kg/day

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

1.15 [0.39, 3.39]

24 Haemoglobin (g/L): mean change from baseline Show forest plot

1

144

Mean Difference (IV, Fixed, 95% CI)

1.54 [‐0.82, 3.90]

24.1 Deferasirox 5 mg/kg/day

1

71

Mean Difference (IV, Fixed, 95% CI)

1.00 [‐2.31, 4.31]

24.2 Deferasirox 10 mg/kg/day

1

73

Mean Difference (IV, Fixed, 95% CI)

2.10 [‐1.27, 5.47]

25 Transferrin saturation (%): mean change from baseline Show forest plot

1

141

Mean Difference (IV, Fixed, 95% CI)

‐7.10 [‐11.71, ‐2.50]

25.1 Deferasirox 5 mg/kg/day

1

70

Mean Difference (IV, Fixed, 95% CI)

‐7.16 [‐12.95, ‐1.37]

25.2 Deferasirox 10 mg/kg/day

1

71

Mean Difference (IV, Fixed, 95% CI)

‐7.01 [‐14.59, 0.57]
Figuras y tablas -
Comparison 8. Non‐transfusion‐dependent thalassemia: deferasirox vs placebo
Ir a la tabla de la revisión