Table 3.
Adverse drug reactions occurring in >1 patient in the Japanese early post-marketing phase vigilance period
| Event (n) | Serious | Non-serious | All |
|---|---|---|---|
| All events | 24 | 89 | 113 |
| Arthralgia | 2 | 11 | 13 |
| Rash | 1 | 7 | 8 |
| Pyrexia | 2 | 6 | 8 |
| Myalgia | 1 | 6 | 7 |
| Drug eruption | 2 | 4 | 6 |
| Photosensitivity reaction | 5 | 5 | |
| Skin disorder | 1 | 3 | 4 |
| Hypersensitivity | 3 | 3 | |
| Alopecia | 3 | 3 | |
| Erythema multiforme | 1 | 2 | 3 |
| PPE | 3 | 3 | |
| Decreased appetite | 2 | 2 | |
| Bundle branch block right | 2 | 2 | |
| Diarrhoea | 2 | 2 | |
| Hepatic function abnormal | 2 | 2 | |
| Acne | 2 | 2 | |
| Erythema nodosum | 2 | 2 | |
| Hyperkeratosis | 2 | 2 | |
| Malaise | 2 | 2 | |
| QT prolonged | 2 | 2 | |
| Neutrophil count decreased | 1 | 1 | 2 |
| Platelet count decreased | 2 | 2 |
PPE palmar–plantar erythrodysesthesia syndrome