TABLE 4.
Self-Rated Adverse Events of Special Interest During Cycle A
| Adverse Event | THC:CBD, No. (%) | Placebo, No. (%) | THC:CBD, No. (%) | Placebo, No. (%) | Mean Difference (95% CI) |
P Fisher's Exact Test |
|---|---|---|---|---|---|---|
| Any severity | Moderate or severe | |||||
| Sedation | 40 (56) | 18 (24) | 13 (18) | 5 (7) | 11 (0.6 to 22) | .05 |
| Dizziness | 30 (42) | 10 (14) | 7 (10) | 0 | 10 (3 to 17) | .006 |
| Anxiety | 5 (7) | 6 (8) | 3 (4) | 1 (1) | 3 (–3 to 8) | .4 |
| Disorientation | 13 (18) | 4 (5) | 3 (4) | 0 | 4 (–0.5 to 9) | .12 |
| Hallucinations | 1 (1) | 1 (1) | 0 | 0 | ||
| Palpitations | 5 (7) | 5 (7) | 0 | 0 | ||
| Any AESIa | 53 (74) | 28 (38) | 18 (25) | 6 (8) | 17 (5 to 29) | .007 |
NOTE. Self-rated AESI were collected during daily assessment between D-1 and D6, and included the following known cannabis-related adverse events: sedation, anxiety, disorientation, dizziness, hallucinations, and palpitations.
Abbreviations: AESI, adverse events of special interest; CBD, cannabidiol; THC, tetrahydrocannabinol.
a
Number of participants experiencing ≥1 event during cycle A.