Table 5.

Commonly reported treatment-emergent adverse events (preferred terms in ≥ 10% of participants for any treatment) (safety analysis set)

System organ class preferred term	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
Participants with ≥ 1 TEAE	63 (52.1%) 130	45 (37.8%) 65	70 (57.4%) 162	70 (58.8%) 142	107 (85.6%) 499
Nervous system disorders	44 (36.4%) 66	27 (22.7%) 30	45 (36.9%) 65	49 (41.2%) 68	89 (71.2%) 229
Somnolence	23 (19.0%) 24	10 (8.4%) 10	18 (14.8%) 19	25 (21.0%) 25	47 (37.6%) 78
Headache	11 (9.1%) 12	12 (10.1%) 12	16 (13.1%) 17	12 (10.1%) 13	35 (28.0%) 54
Dizziness	12 (9.9%) 12	3 (2.5%) 3	9 (7.4%) 9	12 (10.1%) 12	28 (22.4%) 36
Psychiatric disorders	15 (12.4%) 15	0	24 (19.7%) 27	22 (18.5%) 26	41 (32.8%) 68
Euphoric mood	14 (11.6%) 14	0	17 (13.9%) 18	17 (14.3%) 17	32 (25.6%) 49

TEAEs were defined as AEs that occurred following the administration of IP

E number of events, IP investigational product, N number of participants in group, n number of participants with observations, TEAE treatment-emergent adverse event