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 @ 1:36 PM
Ignite Modification Date: 2025-12-25 @ 12:35 PM
NCT ID: NCT02384395
Description: None
Frequency Threshold: 5
Time Frame: From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
Study: NCT02384395
Study Brief: Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DTG/3TC/ABC FDC Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection. 0 None 5 37 21 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Exacerbation of Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 24.1 View
Acute Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 24.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 24.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 24.1 View
Acute Stress Reaction SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 24.1 View
Chest Pain associated with Back Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 24.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 24.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 24.1 View
Anterior Uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 24.1 View
Left Scrotal Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 24.1 View
Left Scrotal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 24.1 View
Diabetic Ketoacidosis without coma associated with T1DM SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 24.1 View
Elevated Alanine Aminotransferase (ALT) SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 24.1 View
Elevated Aspartate Aminotransferase (AST) SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALT Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 24.1 View
Citrate Sensitivity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 24.1 View
Creatinine Clearance Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 24.1 View
Elevated BP During Leukapheresis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 24.1 View
IV Infiltration During Leukapheresis SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 24.1 View