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 @ 10:30 PM
Ignite Modification Date: 2025-12-25 @ 8:03 PM
NCT ID: NCT03405935
Description: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9
Study: NCT03405935
Study Brief: Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
B/F/TAF B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks. 2 None 9 86 34 86 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Ischaemic cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Covid-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Alcohol withdrawal syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View