Adverse Events Module

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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: 2025-12-24 @ 2:50 PM
Ignite Modification Date: 2025-12-25 @ 1:17 PM
NCT ID: NCT04714359
Description: None
Frequency Threshold: 5
Time Frame: From baseline to end of follow up (approximately 18 weeks)
Study: NCT04714359
Study Brief: A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for 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
Pre-Treatment MDMA-Assisted Therapy Adverse events that occur during the Preparatory Period prior to the first dose in the first MDMA-assisted therapy session. 0 None 0 85 51 85 View
On Day 0, 1, or 2 MDMA-Assisted Therapy Adverse events that occur on the day of or within two days following each MDMA-assisted therapy session. 0 None 0 85 84 85 View
Treatment-Emergent Adverse Events MDMA-Assisted Therapy Adverse events that occur during the Treatment Period from the first Experimental Session to the last Integrative Session. 0 None 3 85 84 85 View
Follow-Up MDMA-Assisted Therapy Adverse Events that occurred after the last Integrative Session through follow-up. 0 None 1 85 15 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Colonic abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mydriasis SYSTEMATIC_ASSESSMENT Eye disorders None View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Therapeutic response unexpected SYSTEMATIC_ASSESSMENT General disorders None View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders None View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders None View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders None View
Feeling of body temperature change SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Feeling of relaxation SYSTEMATIC_ASSESSMENT General disorders None View
Feeling jittery SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nystagmus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bruxism SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Emotional disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anger SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View