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 @ 9:59 PM
Ignite Modification Date: 2025-12-25 @ 7:36 PM
NCT ID: NCT03664232
Description: SAEs and other AEs: The safety analysis set included all randomized participants who had received at least 1 dose of study drug. All-cause mortality: all randomized analysis set included all participants who were randomized in the study (that is, participants who reported a randomization date or were assigned a randomization number) regardless of whether treatment was received.
Frequency Threshold: 5
Time Frame: Serious adverse events (SAEs) and other adverse events (AEs): From Day 1 up to 6 days post last dose of study drug (up to 91 days); All-cause mortality: From screening (Day -26) up to 99 days
Study: NCT03664232
Study Brief: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum 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 QD Participants enrolled prior to protocol amendment-5, received placebo matched to JNJ-42165279 tablets orally once daily (QD) from Day 1 to Day 85. 0 None 0 7 5 7 View
Placebo BID Participants enrolled after protocol amendment-5 received placebo matched to JNJ-42165279 tablets orally twice daily (BID) from Day 1 to Day 85. 0 None 0 30 7 30 View
JNJ-42165279 25 mg QD Participants enrolled prior to protocol amendment-5 received JNJ-42165279 25 milligrams (mg) tablets orally QD from Day 1 to Day 85. 0 None 0 8 7 8 View
JNJ-42165279 25 mg BID Participants enrolled after protocol amendment-5 received JNJ-42165279 25 mg tablets orally BID from Day 1 to Day 85. 0 None 0 32 3 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Early Repolarisation Syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 25.0 View
Motion Sickness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 25.0 View
Abdominal Discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 25.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 25.0 View
Medical Device Site Rash NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 25.0 View
Seasonal Allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA Version 25.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 25.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 25.0 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 25.0 View
Ligament Sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 25.0 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 25.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 25.0 View
Increased Appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 25.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 25.0 View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 25.0 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 25.0 View
Oropharyngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 25.0 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 25.0 View