Table 2 Summary of adverse events recorded up to day 28, safety population (both studies)
Study-T (> 5 years) | Study-E (6-59 months) | |||
|---|---|---|---|---|
Patients N (%) | ASAQ | AL | ASAQ | AL |
N = 496 | N = 502 | N = 149 | N = 150 | |
AE summary | ||||
At least one AE (any grade) | 457 (92.1) | 453 (90.2) | 141 (94.6) | 132 (88.0) |
At least one AE ≥ grade 3 | 17 (3.4) | 8 (1.6) | 6 (4.0) | 4 (2.7) |
Serious AE (SAE) | 1 (0.2) * | 0 (0) | 2 (1.3) | 1 (0.7) |
AE leading to treatment discontinuation | 0 | 0 | 0 | 1 (0.7) |
Common clinical- or laboratory AEs (≥5% in at least one study arm, any severity grade) # | ||||
Fatigue ** | 200 (39.8) | 81 (16.3) | 43 (28.9) | 20 (13.3) |
Headache | 52 (10.5) | 42 (8.4) | 2 (1.3) | 2 (1.3) |
AE Vomiting (any) | 35 (7.1) | 8 (1.6) | 16 (10.7) | 10 (6.7) |
AE Vomiting (after drug intake) | 2 (0.4) | 0 | 9 (6.0) | 4 (2.7) |
Abdominal pain | 29 (5.8) | 18 (3.6) | 3 (2.0) | 4 (2.7) |
Anorexia | 29 (5.8) | 7 (1.4) | 2 (1.3) | 2 (1.3) |
Cough | - | - | 28 (18.8) | 21 (14.0) |
Diarrhoea | 20 (4.0) | 14 (2.8) | 14 (9.4) | 14 (9.3) |
Eosinophilia ≠ | 144 (29.0) | 185 (36.9) | 6 (4.0) | 9 (6.0) |
Neutropaenia | 94 (19.0) | 110 (21.9) | 6 (4.0) | 8 (5.3) |
Leukopaenia | 37 (7.5) | 29 (5.8) | 10 (6.7) | 3 (2.0) |
Leukocytosis | 21 (4.2) | 44 (8.8) | 10 (6.7) | 11 (7.3) |
Anaemia | 74 (14.9) | 49 (9.8) | 34 (22.8) | 23 (15.3) |
AST increased | 17 (3.4) | 21 (4.2) | 8 (5.4) | 12 (8.0) |
ALT increased | 11 (2.2) | 17 (3.4) | 10 (6.7) | 12 (8.0) |