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 @ 12:37 PM
Ignite Modification Date: 2025-12-25 @ 12:11 PM
NCT ID: NCT00344461
Description: A written report will be filed with the Institutional Review Board (IRB) within 5 working days for serious adverse event and annually for all others.
Frequency Threshold: 0
Time Frame: 96 weeks
Study: NCT00344461
Study Brief: A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FTC, TDF, & NVP To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection. 1 None 16 54 13 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutrapenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Grade 3 & 4 Liver Function Test NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Grade 4 alanine aminotransferase (ALT) test NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
CMV Retinitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Aortic Aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Diffused Lung Disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right Femoral Deep Vein Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hepatotoxicity NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Malignant Lymphoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Syncopy NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Drug Detoxicity NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Herpes Zoster Othalmicus NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Left Hand Trauma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Stabbing NON_SYSTEMATIC_ASSESSMENT General disorders None View
Viral Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Preseptal Cellulitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Viral Syndrome NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abscess Right Leg NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View