Table 4.
Treatment-emergent adverse events in ≥5% in study 1.
| Event, n (%) | Sativex (n = 199) | Placebo (n = 198) |
|---|---|---|
| All causality | ||
| Totala | 136 (68.3) | 127 (64.1) |
| Neoplasm progression | 32 (16.1) | 36 (18.2) |
| Somnolence | 24 (12.1) | 8 (4.0) |
| Nausea | 19 (9.5) | 16 (8.1) |
| Vomiting | 18 (9.0) | 13 (6.6) |
| Dizziness | 16 (8.0) | 9 (4.5) |
| Constipation | 10 (5.0) | 13 (6.6) |
| Treatment-relatedb | ||
| Totala | 64 (32.2) | 41 920.7) |
| Somnolence | 18 (9.0) | 6 (3.0) |
| Dizziness | 15 (7.5) | 6 (3.0) |
| Nausea | 10 (5.0) | 8 (4.0) |
a
Patients with adverse events in multiple system organ classes were counted only once towards the total.
b
Treatment-emergent adverse events judged by the investigator to be at least potentially related to study treatment.