Table 4.
Overall summary of treatment-emergent adverse events (safety analysis set)
| A: Dronabinol 5 mg fasted (N = 121) n (%) E | B: Acetazolamide 250 mg fasted (N = 119) n (%) E | C: IHL-42X-Fasted (N = 122) n (%) E | D: IHL-42X-Fed (N = 119) n (%) E | Overall (N = 125) n (%) E | |
|---|---|---|---|---|---|
| Number (%) of participants reporting ≥ 1 | |||||
| TEAE | 63 (52.1%) 130 | 45 (37.8%) 65 | 70 (57.4%) 162 | 70 (58.8%) 142 | 107 (85.6%) 499 |
| Serious TEAE | 0 | 0 | 0 | 0 | 0 |
| Severe TEAEa | 0 | 0 | 1 (0.8%) 1 | 0 | 1 (0.8%) 1 |
| Related TEAEb | 54 (44.6%) 98 | 26 (21.8%) 31 | 55 (45.1%) 114 | 61 (51.3%) 119 | 97 (77.6%) 362 |
| TEAE leading to study discontinuation | 0 | 0 | 4 (3.3%) 8 | 2 (1.7%) 4 | 5 (4.0%) 12 |
E number of events, IP investigational product, N number of participants in group, n number of participants with observations, TEAE treatment-emergent adverse event
aSevere TEAE was defined as TEAE with severity of severe or life threatening or death
bRelated TEAE was defined as relationship to IP reported as possible, probable or definite