Table 4.
Summary of treatment-emergent adverse events reported in at least 2% of patients
|
Stage 1 g-HAT (n=69) |
Early stage 2 g-HAT (n=19) |
Late-stage 2 g-HAT (n=37) |
Total (n=125) |
|||||
|---|---|---|---|---|---|---|---|---|
| n (%) | Number of events | n (%) | Number of events | n (%) | Number of events | n (%) | Number of events | |
| Any adverse event | 61 (88%) | 316 | 18 (95%) | 75 | 37 (100%) | 195 | 116 (93%) | 586 |
| Gastrointestinal disorders | 55 (80%) | 165 | 15 (79%) | 34 | 28 (76%) | 58 | 98 (78%) | 257 |
| General disorders and administration site conditions | 28 (41%) | 34 | 7 (37%) | 10 | 16 (43%) | 21 | 51 (41%) | 65 |
| Investigations | 12 (17%) | 15 | 1 (5%) | 3 | 7 (19%) | 7 | 20 (16%) | 25 |
| Psychiatric disorders | 1 (1%) | 1 | 2 (11%) | 2 | 16 (43%) | 24 | 19 (15%) | 27 |
| Metabolism and nutrition disorders | 10 (14%) | 12 | 1 (5%) | 1 | 13 (35%) | 14 | 24 (19%) | 27 |
| Blood and lymphatic system disorders | 10 (14%) | 10 | 4 (21%) | 5 | 6 (16%) | 7 | 20 (16%) | 22 |
| Musculoskeletal and connective tissue disorders | 8 (12%) | 8 | 0 | 0 | 5 (14%) | 7 | 13 (10%) | 15 |
| Infections and infestations | 3 (4%) | 3 | 2 (11%) | 2 | 8 (22%) | 11 | 13 (10%) | 16 |
| Eye disorders | 7 (10%) | 7 | 1 (5%) | 1 | 2 (5%) | 2 | 10 (8%) | 10 |
| Respiratory, thoracic, and mediastinal disorders | 5 (7%) | 7 | 0 | 0 | 1 (3%) | 1 | 6 (5%) | 8 |
| Skin and subcutaneous tissue disorders | 2 (3%) | 3 | 0 | 0 | 5 (14%) | 5 | 7 (6%) | 8 |
| Cardiac disorders | 2 (3%) | 3 | 1 (5%) | 1 | 1 (3%) | 1 | 4 (3%) | 5 |
Data are from the complete 18-month timepoint of the intention-to-treat population (n=125). g-HAT=gambiense human African trypanosomiasis.