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 @ 2:48 PM
Ignite Modification Date: 2025-12-25 @ 1:16 PM
NCT ID: NCT01533259
Description: Safety Analysis Set
Frequency Threshold: 5
Time Frame: Up to 48 weeks plus 30 days
Study: NCT01533259
Study Brief: Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stribild Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks None None 1 48 33 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 16 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 16 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 16 View
Seasonal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA Version 16 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 16 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 16 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 16 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 16 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 16 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 16 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 16 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 16 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 16 View