Table 4. Summary of adverse events emerging from cannabidiol treatment for grouped (open-label extension) Lennox-Gataut syndrome, Dravet syndrome, and tuberous sclerosis complex, with median follow-up time of 267–1,090 days.
| Emerging adverse events of treatment during OLE | ||||
|---|---|---|---|---|
| Type of adverse event | Dravet syndrome (n=315) n (%) | Lennox-Gastaut syndrome (n=366) n (%) | Tuberous sclerosis complex (n=199) n (%) | Total (n=880) n (%) |
| All TEAEs | 306 (97) | 353 (96.4) | 184 (92) | 843 (95.8) |
| Graves TEAEs | 132 (42) | 155 (42.3) | 29 (15) | 316 (36) |
| Abandonment due to adverse events | 28 (9) | 43 (11.7) | 12 (6) | 83 (9.4%) |
| Elevated hepatic transaminases* (ALT or AST) >3 × higher | 69 (22%); 58 of which (84%) had concomitant use of valproic acid. | 55 (15%); 40 of which (73%) with concomitant use of valproic acid. | 17 (9%); 12 of which (71 %) with concomitant use of valproic acid | 141 (16) |
OLE: open-label extension; TEAE: treatment-emergent adverse event.
*
Elevations of liver enzymes include only those reported as adverse events.