Table 5.
Suspected Adverse Drug Reactions During the Study Period
| Adverse Drug Reaction | Total (N=3170) | Active Cohort (n=2679) | Passive Cohort (n=491) | |||
|---|---|---|---|---|---|---|
| na | IRb | na | IRb | na | IRb | |
| Total | 548 | 173.0 | 384 | 143.0 | 164 | 334.0 |
| No serious (top 20) | 544 | 172.0 | 383 | 143.0 | 161 | 328.0 |
| Anorexia | 109 | 34.4 | 76 | 28.4 | 33 | 67.2 |
| General weakness | 87 | 27.4 | 58 | 21.6 | 29 | 59.1 |
| Cough | 76 | 24.0 | 50 | 18.7 | 26 | 53.0 |
| Vomiting | 47 | 14.8 | 24 | 9.0 | 6 | 12.2 |
| Dizziness | 37 | 11.7 | 26 | 9.7 | 11 | 22.4 |
| Diarrhea | 36 | 11.4 | 30 | 11.2 | 23 | 46.8 |
| Abdominal pain | 36 | 11.4 | 22 | 8.2 | 14 | 28.5 |
| Pruritus | 14 | 4.4 | 12 | 4.5 | 2 | 4.1 |
| Nausea | 14 | 4.4 | 7 | 2.6 | 2 | 4.1 |
| Fever | 13 | 4.1 | 11 | 4.1 | 0 | 0.0 |
| Rhinitis | 9 | 2.8 | 9 | 3.4 | 0 | 0.0 |
| Somnolence | 9 | 2.8 | 5 | 1.9 | 7 | 14.3 |
| Insomnia | 7 | 2.2 | 7 | 2.6 | 0 | 0.0 |
| Muscle/joint pain | 6 | 1.9 | 6 | 2.2 | 4 | 8.1 |
| Headache | 6 | 1.9 | 4 | 1.5 | 0 | 0.0 |
| Tinnitus | 5 | 1.6 | 3 | 1.1 | 0 | 0.0 |
| Anemia | 4 | 1.3 | 4 | 1.5 | 2 | 4.1 |
| Epigastric pain | 4 | 1.3 | 4 | 1.5 | 0 | 0.0 |
| Dermatosis | 3 | 0.9 | 3 | 1.1 | 2 | 4.1 |
| Chest pain | 2 | 0.6 | 2 | 0.7 | 0 | 0.0 |
| Serious | 4 | 1.3 | 1 | 0.4 | 3 | 6.11 |
| Gastroenteritis | 1 | 0.3 | 0 | 0 | 1 | 2.0 |
| Convulsion | 1 | 0.3 | 1 | 0.4 | 0 | 0 |
| Dizziness | 1 | 0.3 | 0 | 0 | 1 | 2.0 |
| General weakness | 1 | 0.3 | 0 | 0 | 1 | 2.0 |
Notes: aIndicates the number of events; a patient could have one or more events at a time. bIndicates the incidence rate per 1000 (n/N).