Table 2 Adverse events occurring during treatment
From: MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial
MDMA-AT (n = 53) | Placebo with therapy (n = 51) | |
|---|---|---|
Summary of TEAEs and TEAESIs, n (%) | ||
Participants with ≥1 TEAE | 53 (100) | 49 (96.1) |
Participants with ≥1 severe TEAE | 5 (9.4) | 2 (3.9) |
Participants with ≥1 serious TEAE | 0 | 0 |
Participants with ≥1 TEAE leading to study discontinuation | 0 | 2 (3.9) |
Participants with ≥1 TEAESI | 6 (11.3) | 3 (5.9) |
Most commona TEAEs, n (%) | ||
Muscle tightness | 31 (58.5) | 13 (25.5) |
Nausea | 24 (45.3) | 11 (21.6) |
Decreased appetite | 19 (35.8) | 5 (9.8) |
Hyperhidrosis | 18 (34.0) | 3 (5.9) |
Feeling hot | 14 (26.4) | 6 (11.8) |
Feeling cold | 11 (20.8) | 3 (5.9) |
Paresthesia | 10 (18.9) | 1 (2.0) |
Chest discomfort | 9 (17.0) | 2 (3.9) |
Dry mouth | 9 (17.0) | 4 (7.8) |
Chills | 8 (15.1) | 1 (2.0) |
Feeling jittery | 8 (15.1) | 0 |
Restlessness | 8 (15.1) | 2 (3.9) |
Vision blurred | 8 (15.1) | 0 |
Bruxism | 7 (13.2) | 1 (2.0) |
Nystagmus | 7 (13.2) | 1 (2.0) |
Mydriasis | 6 (11.3) | 0 |
Tremor | 6 (11.3) | 0 |
