Table 3. Summary of Safety Events in the Safety Population.
| Adverse event (AE)a | Enrollment through day 43, No. (%) | Randomization through day 9 | Day 10 through day 43 | |||||
|---|---|---|---|---|---|---|---|---|
| Psilocybin (n = 50) | Niacin (n = 54) | Psilocybin (n = 50), No. (%) | Niacin (n = 54), No. (%) | Difference (95% CI), %b | Psilocybin (n = 50), No. (%) | Niacin (n = 53), No. (%) | Difference (95% CI), %b | |
| At least 1 AE | 44 (88) | 33 (61) | 42 (84) | 32 (59) | 25 (8.2 to 41.3) | 18 (36) | 13 (25) | 11 (−6.2 to 29.1) |
| At least 1 related AEc | 41 (82) | 24 (44) | 41 (82) | 24 (44) | 38 (20.6 to 54.6) | 2 (4) | 1 (2) | 2 (−4.4 to 8.7) |
| At least 1 serious AE | 1 (2) | 2 (4) | NC | NC | ||||
| Drug-related AE severityc | ||||||||
| Mild | 39 (78) | 23 (43) | 39 (78) | 23 (43) | 35 (17.9 to 52.9) | 1 (2) | 1 (2) | 0 (−5.2 to 5.5) |
| Moderate | 11 (22) | 2 (4) | 11 (22) | 2 (4) | 18 (5.8 to 30.8) | 1 (2) | NC | |
| Severe | 4 (8) | 4 (8) | NC | 1 (2) | NC | |||
| At least 1 solicited AEd | 38 (76) | 16 (30) | 38 (76) | 16 (30) | 46 (29.4 to 63.4) | NC | ||
| Headachee | 33 (66) | 13 (24) | 33 (66) | 13 (24) | 42 (27.3 to 57.6) | NA | NA | NA |
| Nauseae | 24 (48) | 3 (6) | 24 (48) | 3 (6) | 42 (24.5 to 59.3) | NA | NA | NA |
| Visual perceptual effects on dosing day | 22 (44) | 3 (6) | 22 (44) | 3 (6) | 38 (23.4 to 53.5) | NA | NA | NA |
| Visual perceptual effects after dosing day | 3 (6) | 3 (6) | NC | NC | ||||
| At least 1 AE requiring psychiatric attention | 2 (4) | 1 (2) | 1 (2) | NC | 2 (4) | 1 (2) | 2 (−4.4 to 8.7) | |
| At least 1 psychiatric concomitant medication reportedf | 8 (16) | 7 (13) | 3 (6) | 4 (7) | −1 (−11.0 to 8.2) | 5 (10) | 4 (8) | 2 (−8.5 to 13.4) |
Abbreviations: NA, not applicable (event not solicited during period); NC, not calculable.
Participants are counted once for each category regardless of the number of events.
Wald 95% CIs for difference in incidences between treatment groups (psilocybin – niacin).
An AE was classified as “related” if there was a reasonable possibility that the study drug or procedure caused the event. Severity and relationship to study drug or procedure were determined by the site principal investigator.
Only solicited events with any occurrences during the study are summarized. See eTable 2 in Supplement 3 for a full list of events solicited during the study.
Headache and nausea were only collected as solicited events during randomization through postdose day 9.
Defined as concomitant medications with WHODRUG ATC2 codes N05 – Psycholeptics or N06 – Psychoanaleptics.