Table 2.
Types of Adverse Events | Cumulative | Severity Grading | |||
---|---|---|---|---|---|
Number | Incidence | Mild (N/%) | Moderate (N/%) | Severe (N/%) | |
Headache | 358 | 6.1 | 319 (89.1) | 35 (9.8) | 4 (1.1) |
Abdominal pain | 334 | 5.7 | 294 (88.0) | 36 (0.8) | 4 (1.2) |
Vomiting | 116 | 2.0 | 88 (75.9) | 24 (20.7) | 4 (3.4) |
Dizziness | 92 | 1.6 | 80 (87.0) | 11 (12.0) | 1 (1.1) |
Nausea | 89 | 1.5 | 74 (83.1) | 13 (14.6) | 2 (2.2) |
Fever | 71 | 1.2 | 58 (81.7) | 12 (16.9) | 1 (1.4) |
Confusion | 30 | 0.5 | 27 (90.0) | 3 (10.0) | 0 |
Diarrhea | 29 | 0.5 | 20 (69.0) | 7 (24.1) | 2 (6.9) |
Itching | 21 | 0.4 | 21 (100) | 0 | 0 |
Drowsiness | 13 | 0.2 | 13 (100) | 0 | 0 |
Loss of appetite | 10 | 0.2 | 5 (50.0) | 4 (40.0) | 1(10.0) |
Rash | 4 | 0.1 | 4 (100) | 0 | 0 |
Difficulty Breathing | 3 | 0.1 | 2 (66.7) | 1 (33.3) | 0 |
Cough | 1 | 0 | 1 (100) | 0 | 0 |
Other symptoms | 16 | 0.3 | 13 (81.3) | 1 (6.3) | 2 (12.5) * |
Total | 1187 | 13.3 | 1019 (85.8) | 147 (12.4) | 21 (1.8) |
* Other symptoms—tremor.