Table 5.
Treatment-emergent adverse events in ≥5% of Sativex patients in study 2.
| Event, n (%) | Sativex | Placebo |
|---|---|---|
| Part A: Single-blind treatment | ||
| N | 404 | – |
| All causality | ||
| Totala | 241 (59.7) | – |
| Neoplasm progression | 48 (11.9) | – |
| Somnolence | 46 (11.4) | – |
| Dizziness | 27 (6.7) | – |
| Nausea | 25 (6.2) | – |
| Vomiting | 22 (5.4) | – |
| Decreased appetite | 20 (5.0) | – |
| Treatment-relatedb | ||
| Totala | 128 (31.7) | – |
| Somnolence | 42 (10.4) | – |
| Nausea | 21 (5.2) | – |
| Dizziness | 21 (5.2) | – |
| Part B: Double-blind randomized treatment | ||
| N | ||
| All causality | 103 | 103 |
| Totala | 74 (71.8) | 64 (62.1) |
| Neoplasm progression | 30 (29.1) | 15 (14.6) |
| Weight decreased | 7 (6.8) | 4 (3.9) |
| Anaemia | 6 (5.8) | 7 (6.8) |
| Asthenia | 6 (5.8) | 6 (5.8) |
| Decreased appetite | 6 (5.8) | 3 (2.9) |
| Somnolence | 6 (5.8) | 1 (1.0) |
| Treatment-relatedb | ||
| Totala | 16 (15.5) | 12 (11.7) |
| Somnolence | 6 (5.8) | 0 (0.0) |
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.