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 @ 7:18 PM
Ignite Modification Date: 2025-12-25 @ 4:57 PM
NCT ID: NCT03375203
Description: Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
Frequency Threshold: 5
Time Frame: Up to Day 17
Study: NCT03375203
Study Brief: A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia 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
Zolpidem Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. 0 None 1 73 21 73 View
Placebo Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14. 0 None 0 75 22 75 View
JNJ-42847922 5 mg Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. 0 None 0 72 16 72 View
JNJ-42847922 10 mg Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. 0 None 0 73 10 73 View
JNJ-42847922 20 mg Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. 0 None 1 71 13 71 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cognitive Disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Cerebral Haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Disturbance in Attention NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View