Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
NCT ID:
NCT01958593
Description:
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
Frequency Threshold:
5
Time Frame:
All AEs from baseline to the end of Stage 2 (approximately 10 months)
Study:
NCT01958593
Study Brief:
Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo With Therapy (Stage 2) | Stage 1 placebo participants will receive full-dose MDMA during each of two experimental sessions. 3,4-methylenedioxymethamphetamine: Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session. Psychotherapy: Psychotherapy before and after experimental sessions | 0 | None | 0 | 2 | 2 | 2 | View |
| MDMA-assisted Therapy (Stage 1) | Participants will receive full-dose MDMA during each of two experimental sessions. 3,4-methylenedioxymethamphetamine: Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session. Psychotherapy: Psychotherapy before and after experimental sessions | 0 | None | 0 | 4 | 4 | 4 | View |
| SRRs: Placebo With Therapy | Spontaneously reported reactions (SRRs) on blinded experimental session days and 7 days after. | 0 | None | 0 | 2 | 2 | 2 | View |
| SRRs: MDMA-assisted Therapy | Spontaneously reported reactions (SRRs) on blinded experimental session days and 7 days after. | 0 | None | 0 | 4 | 4 | 4 | View |
| Placebo With Therapy (Stage 1) | Participants will receive placebo during each of two experimental sessions. Placebo: Placebo administered in two experimental sessions; may take part in Stage 2 upon learning condition assignment Psychotherapy: Psychotherapy before and after experimental sessions | 0 | None | 0 | 2 | 2 | 2 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Depressed Mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Emotional distress | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Bruxism | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dissociation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Intentional self-injury | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Difficulty Concentrating | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Impaired Gait/Balance | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Increased Irritability | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Jaw Clenching, Tight Jaw | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Lack of Appetite | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Low mood | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Muscle Tension | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Need More Sleep | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Perspiration | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Ruminations | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sensitivity to Cold | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Weakness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |