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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT04186403
Description: All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
Frequency Threshold: 5
Time Frame: Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
Study: NCT04186403
Study Brief: Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prior Brexpiprazole 2-3 mg/Day Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks. 0 None 1 88 8 88 View
Prior Placebo Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks. 0 None 2 111 31 111 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (24.0) View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (24.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.0) View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (24.0) View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (24.0) View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (24.0) View