Table 6.
Treatment-emergent adverse events occurring in ≥5% of subjects in Cohort 2 (all causalities)
| System organ class preferred term, n (%) | AZCQ N = 124 | AL N = 131 |
|---|---|---|
| Gastrointestinal disorders | ||
| Vomiting* | 38 (30.6) | 13 (9.9) |
| Abdominal pain† | 4 (3.2) | 14 (10.7) |
| Diarrhoea | 4 (3.2) | 8 (6.1) |
| Infections and infestations | ||
| Infection parasitic | 37 (29.8) | 31 (23.7) |
| Malaria | 26 (21.0) | 19 (14.5) |
| Upper respiratory tract infection | 9 (7.3) | 12 (9.2) |
| Bronchitis | 4 (3.2) | 9 (6.9) |
| Respiratory tract infection | 2 (1.6) | 8 (6.1) |
| General disorders and administration site conditions | ||
| Pyrexia | 17 (13.7) | 27 (20.6) |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 15 (12.1) | 13 (9.9) |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 9 (7.3) | 5 (3.8) |
| Nervous system disorders | ||
| Skin and subcutaneous tissue disorders | ||
| Pruritus | 8 (6.5) | 2 (1.5) |
Medical Dictionary for Regulatory Activities (version 13.1) coding dictionary applied.
*p < 0.0001 and †p < 0.05 using Fisher’s exact test.