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 @ 10:00 PM
Ignite Modification Date: 2025-12-25 @ 7:37 PM
NCT ID: NCT01360632
Description: Safety sample comprised of randomized participants in Phase B who received at least one dose of double-blind trial medication. Participants were excluded only if there was evidence that the participant did not take trial medication. If a participant was dispensed trial medication and is lost to follow-up that participant was considered exposed.
Frequency Threshold: 5
Time Frame: AEs were captured from randomization to double-blind treatment at Week 8 to Follow-up 30 (+ 2) days after last dose of study medication.
Study: NCT01360632
Study Brief: Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris 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
Placebo + ADT Participants were administered placebo as an adjunctive therapy to an open label ADT. None None 0 220 29 220 View
Brexpiprazole (1mg + ADT) Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT. None None 1 226 63 226 View
Brexpiprazole (3mg + ADT) Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT. None None 1 229 72 229 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View