Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:25 PM
NCT ID: NCT01769456
Description: Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
Frequency Threshold: 0
Time Frame: Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Study: NCT01769456
Study Brief: An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PCC Behavioral Intervention Group PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP 0 None 3 78 6 78 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA SOC View
Abnormal loss of weight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA SOC View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA SOC View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA SOC View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View