Table 3.
Treatment-emergent adverse events (TEAEs) with an incidence of ≥5% in the main study (0–12 weeks) and extension phase (12–36 weeks), according to MedDRA preferred term
| Number (%) of patients | ||||
|---|---|---|---|---|
| MedDRA preferred term | Main study, N = 366 | Extension phase, N = 211 | ||
| Vomiting | 48 | (13.1) | 15 | (7.1) |
| Nausea | 45 | (12.3) | 9 | (4.3)a |
| Diarrhoea | 35 | (9.6) | 17 | (8.1) |
| Abdominal pain upper | 19 | (5.2) | 2 | (0.9)a |
| Nasopharyngitis | 24 | (6.6) | 23 | (10.9) |
| Total patients with ≥1 TEAE | 259 | (70.8) | 152 | (72.0) |
aValue included for completeness due to ≥5% incidence in other section of the study.