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: 2025-12-25 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:11 AM
NCT ID: NCT01458327
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were collected throughout the study for approximately 12 months during Experimental Session (Visit 2), Integrative Sessions (Visit 3-5), 2-month Follow-up (Visit 6), and 12-month Follow-up (Visit7). AE's that occurred prior to date of first experimental dose were not reported.
Study: NCT01458327
Study Brief: Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy 3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later MDMA-AT: MDMA-assisted therapy 0 None 1 3 1 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Major depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Drug abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dissociation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View