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 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
NCT ID:
NCT01211405
Description:
None
Frequency Threshold:
5
Time Frame:
During entire study duration (approx 12 months)
Study:
NCT01211405
Study Brief:
Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Blinded Low Dose MDMA-assisted Therapy | Participants will receive 30 mg midomafetamine HCl with therapy during each of two blinded experimental sessions. | 0 | None | 1 | 7 | 6 | 7 | View |
| Blinded Medium Dose MDMA-assisted Therapy | Participants will receive 75 mg midomafetamine HCl with therapy on each of two blinded experimental sessions | 0 | None | 0 | 7 | 4 | 7 | View |
| Blinded Full Dose MDMA-assisted Therapy | Participants will receive 125 mg midomafetamine HCl with therapy during each of two blinded experimental sessions, followed by a third open label session. | 0 | None | 0 | 12 | 8 | 12 | View |
| Open-Label Low Dose MDMA-assisted Therapy | Participants who received two sessions of blinded low dose MDMA-assisted therapy were given the option to cross over and receive three additional open-label MDMA-assisted therapy sessions with 100 mg of midomafetamine HCl | 0 | None | 1 | 6 | 6 | 6 | View |
| Open-Label Medium Dose MDMA-assisted Therapy | Participants who received two sessions of blinded medium dose MDMA-assisted therapy were given the option to cross over and receive three additional open-label MDMA-assisted therapy sessions with 100 mg of midomafetamine HCl | 0 | None | 0 | 6 | 4 | 6 | View |
| Open-Label Full Dose MDMA-assisted Therapy | Participants who received two sessions of blinded full dose MDMA-assisted therapy received a third open-label session with 125 mg midomafetamine HCl | 0 | None | 0 | 12 | 4 | 12 | View |
| Low Dose Group 12 Month Follow-Up | Participants followed for 12 months from end of Stage or 2 | 0 | None | 1 | 6 | 0 | 6 | View |
| Medium Dose Group 12 Month Follow-Up | Participants followed for 12 months from end of Stage or 2 | 0 | None | 1 | 7 | 0 | 7 | View |
| Full Dose Group 12 Month Follow-Up | Participants followed for 12 months from end of Stage or 2 | 0 | None | 0 | 11 | 0 | 11 | View |
| SRRS: Low Dose | Spontaneously reported reactions (SRRs) on day of blinded experimental sessions and 7 days after. | 0 | None | 0 | 7 | 7 | 7 | View |
| SRRs: Medium Dose | Spontaneously reported reactions (SRRs) on day of blinded experimental sessions and 7 days after. | 0 | None | 0 | 7 | 7 | 7 | View |
| SRRs: Full Dose | Spontaneously reported reactions (SRRs) on day of blinded experimental sessions and 7 days after. | 0 | None | 0 | 12 | 12 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Major Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 25.1 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Vitreous floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Venomous sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Tic | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Trichotillomania | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Tooth abcess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Sleep deficit | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Flashback | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Intrusive thoughts | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Time perception altered | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Pseudofolliculitis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Irritable bowel syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Cyst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Tinea pedis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Hypnagogic hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Hypnopompic hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Difficulty Concentrating | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Impaired Judgment | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Impaired Gait/Balance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Increased Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Jaw Clenching, Tight Jaw | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Lack of Appetite | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Low Mood | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Muscle Tension | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Need More Sleep | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Perspiration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Ruminations | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Sensitivity to Cold | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Weakness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |