1 Mortality at any time point |
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 |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
3 LIC (mg/g) evaluated by MRI (R2*): mean change from baseline |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
4 Myocardial T2* (ms): mean change from baseline |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
5 Serious AE (# participants affected) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
6 Serious drug‐related AE (# participants affected) |
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 |
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 |
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) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
10 Drug‐related AEs |
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) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
12 Non‐related drug AEs |
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) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
14 Initial gastrointestinal manifestations (# participants affected) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
15 Quality of life (%) (measured by SF‐36): mean change from baseline |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
16 Adherence: actual dose/total prescribed dose |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
17 Discontinuations |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
18 Serious AE resulting in study discontinuation or interruption |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |