Table 3.
TEAEs deemed related to treatment by investigator
| System organ class Preferred term |
PA group | AA group | All participants (ntotal = 34) |
||
|---|---|---|---|---|---|
| Stage 1 | Stage 2 | Stage 1 | Stage 2 | ||
| Placebo (ntotal = 17) |
DMT after placebo (ntotal = 16) |
DMT (ntotal = 17) |
DMT after active (ntotal = 13) |
||
| n (%) (number of events) | |||||
| Total | 4 (23.5) | 10 (62.5) | 11 (64.7) | 3 (23.1) | 25 (73.5) |
| General disorders and administration site conditions | 3 (17.6) | 6 (37.5) | 7 (41.2) | 1 (7.7) | 16 (47.1) |
| Infusion site pain | 3 (17.6) (3) | 6 (37.5) (6) | 6 (35.3) (6) | 1 (7.7) (1) | 15 (44.1) (16) |
| Catheter site-related reaction | – | – | 1 (5.9) (1) | – | 1 (2.9) (1) |
| Psychiatric disorders | 1 (5.9) | 6 (37.5) | 3 (17.6) | 1 (7.7) | 10 (29.4) |
| Anxiety | – | 3 (18.8) (3) | 2 (11.8) (2) | – | 5 (14.7) (5) |
| Insomnia | 1 (5.9) (1) | 1 (6.3) (1) | – | – | 2 (5.9) (2) |
| Restlessness | – | 1 (6.3) (1) | 1 (5.9) (1) | – | 2 (5.9) (2) |
| Depression | – | 1 (6.3) (1) | – | – | 1 (2.9) (1) |
| Emotional distress | – | 1 (6.3) (1) | – | – | 1 (2.9) (1) |
| Middle insomnia | – | – | – | 1 (7.7) (1) | 1 (2.9) (1) |
| Pseudohallucination | – | – | 1 (5.9) (1) | – | 1 (2.9) (1) |
| Gastrointestinal disorders | – | 3 (18.8) | 3 (17.6) | – | 6 (17.6) |
| Nausea | – | 3 (18.8) (3) | 3 (17.6) (3) | – | 6 (17.6) (6) |
| Nervous system disorders | – | 1 (6.3) | 3 (17.6) | – | 4 (11.8) |
| Headache | – | 1 (6.3) (1) | 1 (5.9) (1) | – | 2 (5.9) (2) |
| Disturbance in attention | – | – | 1 (5.9) (1) | – | 1 (2.9) (1) |
| Paresthesia | – | – | 1 (5.9) (1) | – | 1 (2.9) (1) |
| Musculoskeletal and connective tissue disorders | – | 1 (6.3) | 1 (5.9) | – | 2 (5.9) |
| Muscle tightness | – | 1 (6.3) (1) | – | – | 1 (2.9) (1) |
| Pain in extremity | – | – | 1 (5.9) (1) | – | 1 (2.9) (1) |
| Vascular disorders | – | – | 2 (11.8) | – | 2 (5.9) |
| Hypertension | – | – | 1 (5.9) (1) | – | 1 (2.9) (1) |
| Pallor | – | – | 1 (5.9) (1) | – | 1 (2.9) (1) |
| Ear and labyrinth disorders | – | – | – | 1 (7.7) | 1 (2.9) |
| Tinnitus | – | – | – | 1 (7.7) (1) | 1 (2.9) (1) |
| Eye disorders | – | – | 1 (5.9) | – | 1 (2.9) |
| Visual snow syndrome | – | – | 1 (5.9) (1) | – | 1 (2.9) (1) |
| Skin and subcutaneous tissue disorders | – | 1 (6.3) | – | – | 1 (2.9) |
| Night sweats | – | 1 (6.3) (1) | – | – | 1 (2.9) (1) |
TEAEs occurring from randomization (dosing) on day 1 to day 14 inclusive are included in stage 1. TEAEs occurring from dosing on day 15 until the end of the study are included in stage 2. TEAEs that occurred on the day of, but before dosing in stage 2 (day 15), are not included in the table. Participants with ≥1 TEAE are counted only once per system organ class and preferred term. ntotal, total number of participants; n, number of participants with a TEAE.