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 @ 3:54 AM
Ignite Modification Date: 2025-12-26 @ 2:44 AM
NCT ID: NCT01910402
Description: All-Cause Mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase, which comprised of all randomized participants who received at least one dose of study treatment. Safety-Continuation Population was used for the Continuation Phase which comprised of all participants in the DTG/ABC/3TC group who received at least 1 dose of study treatment after entering the Continuation Phase.
Frequency Threshold: 5
Time Frame: All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 48 for Randomized Phase; from Weeks 48 to 432 for Continuation Phase
Study: NCT01910402
Study Brief: A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
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 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase. 1 None 12 248 138 248 View
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase. 0 None 20 247 164 247 View
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available. 1 None 13 149 30 149 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthritis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Malaria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Meningitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Acute psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Intentional self-injury SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hepatitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Rectocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Iliac artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Scleroderma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V25.0 View
Acute hepatitis C SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V25.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V25.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V25.0 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA V25.0 View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA V25.0 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA V25.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA V25.0 View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA V25.0 View
Diabetic foot infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V25.0 View
Diabetic foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA V25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Ocular icterus SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA V25.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA V25.0 View