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: 2025-12-25 @ 1:20 AM
Ignite Modification Date: 2025-12-25 @ 11:28 PM
NCT ID: NCT00458393
Description: Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
Frequency Threshold: 5
Time Frame: Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Study: NCT00458393
Study Brief: Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TDF/FTC Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate None None 92 1226 906 1226 View
Placebo Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate None None 94 1230 937 1230 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bone Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
CREATININE INCREASE SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
SUICIDE ATTEMPT SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
SUICIDAL IDEATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
ALT INCREASE SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
AST SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
APPENDICITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10.0) View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
SUICIDAL DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
MAJOR DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
OTHER EVENTS SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
PARASITIC INFECTION INTESTINAL SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
BILIRUBIN INCREASE SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
BLOOD GLUCOSE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
BLOOD PHOSPHORUS DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
URETHRITIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.0) View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
DEPRESSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
SYPHILIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
SECONDARY SYPHILIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
BLOOD AMYLASE INCREASED SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View