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 @ 9:57 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT01458132
Description: All Subject Population was used
Frequency Threshold: 5
Time Frame: Up to 17 months
Study: NCT01458132
Study Brief: Drug Exposure Registry for GSK2248761, an Investigational NNRTI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Participants With Seizure Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and experienced seizure during the follow-up period, after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials. 0 None 0 4 4 4 View
Participants Without Seizure Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials. 0 None 1 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Eye abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Gastroenteritis salmonella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.1 View
Intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Tobacco withdrawal symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View