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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:38 AM
NCT ID: NCT04855760
Description: A TEAE is defined as an AE that starts or worsens at any time after initiation of study drug collected up to 1 month post treatment (Day 395) as collected in the Safety Analysis Set.
Frequency Threshold: 5
Time Frame: A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 1 month post treatment (Day 395) as collected in the Safety Analysis Set.
Study: NCT04855760
Study Brief: Safety of REL-1017 for Major Depressive 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
REL-1017 Total participants in Open Label Study REL-1017: REL-1017 tablet 0 None 8 624 142 624 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Alcohol abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Anaphylactic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperreflexia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Upper respiratory tract infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View