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 @ 7:16 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT02432703
Description: Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).
Frequency Threshold: 5
Time Frame: Up to 20 weeks
Study: NCT02432703
Study Brief: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety 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
Placebo Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks. 0 None 0 75 27 75 View
JNJ-42165279 25 mg Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks. 0 None 2 74 26 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylactic Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA Version 19.1 View
Alcohol Use Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.1 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 19.1 View