Table 4 Probable drug-related AEs observed during the study
Adverse events | Follow-up days and number (frequency) of adverse events (N = 90) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Day-0 | Day-1 | Day-2 | Day-3 | Day-7 | Day-14 | Day-21 | Day-28 | Day-35 | Day-42 | Total n (%) | |
Headache | 5 (5.5) | 3 (3.3) | 3 (3.3) | – | – | – | – | – | – | – | 11 (12.2) |
Anorexia | 2 (2.2) | 4 (4.4) | 3 (3.3) | – | – | – | – | – | – | – | 9 (10.0) |
Mouth ulcer | 2 (2.2) | 4 (4.4) | 2 (2.2) | 1(1.1) | – | – | – | – | – | – | 9 (10.0) |
Vomiting | 2 (2.2) | 1 (1.1) | – | – | – | – | – | – | – | – | 3 (3.3) |
Abdominal pain | – | 3 (3.3) | 3 (3.3) | 2 (2.2) | – | – | – | – | – | – | 8 (8.9) |
Diarrhea | – | 1 (1.1) | 2 (2.2) | 2 (2.2) | – | – | – | – | – | – | 5 (5.6) |
Cough | 2 (2.2) | 2 (2.2) | 2 (2.2) | 2 (2.2) | 1 (1.1) | – | – | – | – | – | 9 (10.0) |
Dizziness | 3 (3.3) | 2 (2.2) | 2 (2.2) | 1 (1.1) | – | – | – | – | – | – | 8 (8.9) |
Total n (%) | 16 (17.6) | 20 (22.0) | 17 (18.7) | 8 (8.8) | 1 (1.1) | – | – | – | – | – | 62 (68.9) |