Table 8 Most common adverse events (reported by ≥10% of patients), total and by dose at onset of AE, safety population (n = 60)
Number (%) of patients | ||||||
|---|---|---|---|---|---|---|
Dose at onset | ||||||
Preferred term | Total | 10 mg | 20 mg | 30, 35 mg | 40, 45 mg | 50 mg |
Headache | 21 (35.0) | 10 (16.7) | 6 (10.0) | 5 (8.3) | 1 (1.7) | 3 (5.0) |
Nausea | 15 (25.0) | 6 (10.0) | 3 (5.0) | 3 (5.0) | 2 (3.3) | 2 (3.3) |
Diarrhoea | 15 (25.0) | 6 (10.0) | 3 (5.0) | 3 (5.0) | 2 (3.3) | 5 (8.3) |
Nasopharyngitis | 15 (25.0) | 5 (8.3) | 2 (3.3) | 6 (10.0) | 1 (1.7) | 2 (3.3) |
Hyperhidrosis | 12 (20.0) | 3 (5.0) | 3 (5.0) | 4 (6.7) | 1 (1.7) | 1 (1.7) |
Upper respiratory tract infection | 12 (20.0) | 2 (3.3) | 5 (8.3) | 3 (5.0) | 2 (3.3) | 2 (3.3) |
Fatigue | 10 (16.7) | 3 (5.0) | 1 (1.7) | 2 (3.3) | 5 (8.3) | 0 (0) |
Dizziness | 10 (16.7) | 3 (5.0) | 2 (3.3) | 4 (6.7) | 0 (0) | 1 (1.7) |
Vomiting | 8 (13.3) | 3 (5.0) | 1 (1.7) | 4 (6.7) | 0 (0) | 2 (3.3) |
Abnormal dreams | 6 (10.0) | 2 (3.3) | 0 (0) | 3 (5.0) | 1 (1.7) | 1 (1.7) |
Arthralgia | 6 (10.0) | 0 (0) | 3 (5.0) | 0 (0) | 3 (5.0) | 0 (0) |
Back pain | 6 (10.0) | 0 (0) | 2 (3.3) | 2 (3.3) | 1 (1.7) | 1 (1.7) |
Influenza like illness | 6 (10.0) | 1 (1.7) | 1 (1.7) | 1 (1.7) | 1 (1.7) | 3 (5.0) |
Influenza | 6 (10.0) | 0 (0) | 2 (3.3) | 1 (1.7) | 0 (0) | 3 (5.0) |
Lethargy | 6 (10.0) | 2 (3.3) | 2 (3.3) | 0 (0) | 2 (3.3) | 0 (0) |
Oropharyngeal pain | 6 (10.0) | 0 (0) | 2 (3.3) | 2 (3.3) | 1 (1.7) | 1 (1.7) |
Pain in extremity | 6 (10.0) | 0 (0) | 2 (3.3) | 3 (5.0) | 2 (3.3) | 0 (0) |
Rash | 6 (10.0) | 2 (3.3) | 2 (3.3) | 0 (0) | 1 (1.7) | 2 (3.3) |