Table 5 Treatment-emergent, treatment-related adverse events in ≥5% of subjects in any group in each study
Study 1134 | Study 1155 | |||
|---|---|---|---|---|
AZCQ 1,000 mg (N = 114) | MQ 1,250 mg (N = 115) | AZCQ 1,000 mg (N = 113) | MQ 1,250 mg (N = 116) | |
Any AE, n (%) | 89 (78.1) | 71 (61.7) | 80 (70.8) | 72 (62.1) |
Pruritus | 58 (50.9) | 11 (9.6) | 32 (28.3) | 1 (0.9) |
Dizziness | 11 (9.6) | 26 (22.6) | 18 (15.9) | 19 (16.4) |
Vomiting | 18 (15.8) | 12 (10.4) | 4 (3.5) | 20 (17.2) |
Headache | 15 (13.2) | 11 (9.6) | 20 (17.7) | 25 (21.6) |
Abdominal pain | 8 (7.0) | 13 (11.3) | 13 (11.5) | 9 (7.8) |
Nausea | 9 (7.9) | 13 (11.3) | 10 (8.8) | 12 (10.3) |
Asthenia | 6 (5.3) | 11 (9.6) | 9 (8.0) | 3 (2.6) |
Palpitations | 3 (2.6) | 7 (6.1) | – | – |
Diarrhoea | 6 (5.3) | 5 (4.3) | 11 (9.7) | 4 (3.4) |
Fatigue | – | – | 4 (3.5) | 6 (5.2) |
Pain | 2 (1.8) | 2 (1.7) | 6 (5.3) | 1 (0.9) |