Table 3 Adverse events by treatment groups (safety population)
System organ class | ASAQ arm (N = 202) n (%) | AQ arm (N = 98) n (%) |
|---|---|---|
Total subjects with at least one AE | 114 (56.4) | 58 (59.2) |
Blood and lymphatic system disorders | 23 (11.4) | 7 (7.1) |
Eye disorders | 1 (0.5) | 0 (0.0) |
Gastrointestinal disorders | 56 (27.7) | 28 (28.6) |
General disorders | 53 (26.2) | 35 (35.7) |
Hepato-biliary disorders | 2 (1.0) | 2 (2.0) |
Immune System disorders | 1 (0.5) | 0 (0.0) |
Infections and Infestations | 1 (0.5) | 0 (0.0) |
Investigation abnormalities | 13 (6.4) | 3 (3.1) |
Metabolism and nutrition disorders | 0 (0.0) | 1 (1.0) |
Musculoskeletal and connective tissue disorders | 2 (1.0) | 5 (5.1) |
Nervous system disorders | 18 (8.9) | 14 (14.3) |
Respiratory, thoracic and mediastinal disorders | 5 (2.5) | 2 (2.0) |
Skin and subcutaneous tissue disorders | 0 (0.0) | 1 (1.0) |
Vascular disorders | 3 (1.5) | 2 (2.0) |