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 @ 3:43 PM
Ignite Modification Date: 2025-12-25 @ 1:51 PM
NCT ID: NCT02498392
Description: Safety analysis set included all randomized participants who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: Up to Week 18
Study: NCT02498392
Study Brief: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Double-blind (DB) Lead-in Period: Placebo All participants received matching placebo tablets orally once daily (qd) during the double blind lead-in period. 0 None 2 160 16 160 View
DB Treatment + Withdrawal Period: Placebo All participants received matching placebo tablets orally qd during the double blind lead-in period. Participants were then assessed for response according to criteria based on reduction from lead-in baseline in Hamilton depression rating scale (HDRS17) and continued to receive adjunctive matching placebo tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant. 0 None 1 76 4 76 View
DB Treatment + Withdrawal Period: JNJ-42165279 25 mg Participants receiving matching placebo tablets during the double blind lead-in period were randomized to receive JNJ-42165279 25 milligrams (mg) tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant. 0 None 1 77 3 77 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.1 View
Foot Deformity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.1 View