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 @ 4:44 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT03095066
Description: Safety population- all participants who received at least one dose of study medication. As pre-specified in SAP, data was collected and reported by pooling the participants into one of the 2 arms based on the treatment received during the study (placebo / AVP-786). All Placebo arm includes participants who were treated with placebo in Stages 1, Stage 2, or both stages of the study. All AVP-786 arm includes participants who received AVP-786 throughout the study and only in Stage 2.
Frequency Threshold: 5
Time Frame: From start of study up to 7 days after the last dose of study drug (up to 13 weeks)
Study: NCT03095066
Study Brief: Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Placebo Participants received AVP-786 matching placebo capsules, orally, BID, during Stage 1 or Stage 2 of the study treatment. 0 None 0 83 4 83 View
All AVP-786 Participants who were randomized to receive AVP-768 throughout the study and participants who were randomized to receive placebo in Stage 1 and were then re-randomized after Week 6 to receive AVP-786 in Stage 2. Participants received AVP-786-28/4.9 capsule along with AVP-786 matching placebo capsule, orally, QD for 1 week, followed by AVP-786-28/4.9 capsule, orally, BID, for the next one week and AVP-786-42.63/4.9 capsules (target dose), orally, BID during the rest of the treatment period. 0 None 3 115 7 115 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Enterobacter sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View