Table 5 Treatment emergent adverse events, TEAEs (Study 1)
Group | 1A | 1B | 1C | 1D |
|---|---|---|---|---|
N | 34 | 30 | 30 | 19 |
Patients with any TEAE | 18 (52.9%) | 18 (60%) | 14 (46.7%) | 11 (57.9%) |
Patients with any serious AE | 3 (8.8%) | 0 | 0 | 1 (5.3%) |
Patients who did not complete study treatment | 0 | 0 | 0 | 2 |
Headache | 4 (11.8%) | 4 (13.3%) | 3 (10%) | 3 (15.8%) |
Dizziness | 1 (2.9%) | 1 (3.3%) | 2 (6.7%) | 0 |
Convulsion | 0 | 0 | 0 | 1 (5.3%) |
Paraesthesia | 0 | 1 (3.3%) | 0 | 0 |
Vertigo | 2 (5.9%) | 2 (6.7%) | 0 | 0 |
Gastrointestinal disorders | 3 (8.8%) | 7 (23.3%) | 1 (3.3%) | 5 (26.3%) |
General Disorders/Administration site disorders | 3 (8.8%) | 1 (3.3%) | 0 | 1 (5.3%) |
Hypertension | 0 | 1 (3.3%) | 0 | 0 |
Hypotension | 1 (2.9%) | 1 (3.3%) | 7 (23.3%) | 0 |
Thrombocytopenia | 0 | 0 | 0 | 2 (10.5%) |
Bradycardia | 1 (2.9%) | 0 | 0 | 0 |
Tachycardia | 0 | 1 (3.3%) | 0 | 0 |
Cough | 2 (5.9%) | 2 (6.7%) | 1 (3.3%) | 1 (5.3%) |
Eyelid pruritus | 0 | 0 | 0 | 1 (5.3%) |
Pruritus | 0 | 1 (3.3%) | 0 | 0 |
Urticaria | 1 (2.9%) | 0 | 0 | 0 |
Arthralgia | 1 (2.9%) | 3 (19%) | 1 (3.3%) | 0 |
Neck pain | 2 (5.9%) | 1 (3.3%) | 0 | 0 |
Cytolytic hepatitis | 1 (2.9%) | 0 | 0 | 0 |
Malaria | 2 (5.9%) | 0 | 0 | 0 |
Pneumonia | 1 (2.9%) | 0 | 0 | 0 |
Rhinitis | 2 (5.9%) | 0 | 0 | 0 |