Table 2.
Incidence rates for special interest events
| Adverse event of special interest | Response | n (%) | Incidence ratea |
|---|---|---|---|
| Clinically significant AEs | Yes | 216 (23) | 0.098 |
| No/not recorded | 725 (77) | ||
| Medical attention required due to fall-related injury | Yes | 61 (6) | 0.028 |
| No/not recorded | 880 (94) | ||
| Other significant psychiatric or psychotic events | Yes | 55 (6) | 0.025 |
| No/not recorded | 886 (94) | ||
| Suicidal thoughts or attempted suicide | Yes | 15 (2) | 0.007 |
| No/not recorded | 926 (98) | ||
| Change in driving ability | Improved | 63 (7) | 0.028 |
| Deteriorated | 19 (2) | 0.009 | |
| Both improved and deterioratedb | 2 (0.2) | 0.001 | |
| No change | 303 (32) | ||
| Not appropriate | 514 (55) | ||
| Not recorded | 40 (4) |
Notes:
Per year of THC:CBD exposure, calculated by dividing the number of patients reporting the AE of special interest by the total patient-years of THC:CBD exposure in the Registry (2,213.98 years).
Improvement and deterioration reported at different DCPs.
Abbreviations: AE, adverse event; CBD, cannabidiol; DCP, data collection period; THC, Δ9-tetrahydrocannabinol.