Table 3

Treatment-emergent adverse events (TEAEs)

TotalDizzinessNausea/ VomitingSomnolence /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 201420Not reportedNabiximols 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 201217No 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 201016From 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).