Treatment-emergent adverse events (TEAEs)
| Total | Dizziness | Nausea/ Vomiting | Somnolence /Fatigue | |
| Lichtman et al 201819* | Nabiximols vs placebo: 70 (35.2%) vs 41 (20.7%) | Nabiximols vs placebo: 15 (7.5%) vs 5 (2.5%) | Nabiximols vs placebo: nausea 17 (8.5%) vs 10 (5.1%) | Occurred at an incidence of <5% within each treatment group |
| Fallon et al 201718
Study 1* | Nabiximols vs placebo: 64 (32.2%) vs 41 (20.7%) | Nabiximols vs placebo: 15 (7.5%) vs 6 (3.0%) | Nabiximols vs placebo: nausea 10 (5.0%) vs 8 (4.0%) | Nabiximols vs placebo: somnolence 18 (9.0%) vs 6 (3.0%) |
| Fallon et al 201718
Study 2 single-blind enrichment phase* | 128 (31.7%) | Dizziness 21 (5.2%) | Nausea 21 (5.2%) | Somnolence 42 (10.4%) |
| Fallon et al 201718
Study 2 double-blind randomised controlled trial* | Nabiximols vs placebo: 16 (15.5%) 12 (11.7%) | Occurred at an incidence of <5% within either treatment group | Occurred at an incidence of <5% within either treatment group | Nabiximols vs placebo: somnolence 6 (5.8%) vs 0 (0.0%) |
| Lynch et al 201420 | Not reported | Nabiximols vs placebo: 6 (66.7%) vs 0 | Nabiximols vs placebo: Nausea 6 (66.7%) vs 1 (11.1%) | Nabiximols vs placebo: Fatigue 7 (77.8%) vs 0 |
| Portenoy et al 201217 | No of TEAEs Nabiximols at a low dose 270, medium dose 311, high dose 334, all 915, placebo 215. Serious TEAE: nabiximols low dose 34 (37.4%), medium dose 18 (20.7%), high dose 27 (30%), all 79 (29.5%); placebo 22 (24.2%) | Nabiximols low dose 10 (11%), medium dose 21 (24.1%), high dose (20 (22.2%) vs placebo 12 (13.2%)† | Nabiximols for nausea low dose 16 (17.6%), medium dose 18 (20.7%), high dose 25 (27.8%) vs placebo 12 (13.2%)† Nabiximols for vomiting low dose 9 (9.9%), medium dose 14 (16.1%), high dose 19 (21.1%) vs placebo 7 (7.7%)† | Nabiximols for somnolence low dose 8 (8.8%), medium dose 16 (18.4%), high dose 15 (16.7%) vs placebo 4 (4.4%)† Nabiximols for fatigue low dose 4 (4.4%), medium dose 4 (4.6%), high dose 5 (5.6%) vs placebo 4 (4.4%)† |
| Johnson et al 201016‡ | From all patients: 106 (60%) | THC:CBD 7 (12%), THC extract 7 (12%) vs placebo 3 (5%) | Nausea: THC:CBD 6 (10%), THC extract 4 (7%) vs placebo 4 (7%) Vomiting: THC:CBD 3 (5%), THC extract 4 (7%) vs placebo 2 (3%) | Somnolence: THC:CBD 8 (13%), THC extract 8 (14%) vs placebo (6 (10%) |
*Treatment-emergent adverse events in ≤5% of patients.
†Treatment-emergent adverse events reported by ≥5% of patients.
‡Treatment-related adverse events (reported by ≥3 patients).