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 @ 11:19 PM
Ignite Modification Date: 2025-12-25 @ 9:01 PM
NCT ID: NCT04114656
Description: All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
Frequency Threshold: 5
Time Frame: All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
Study: NCT04114656
Study Brief: Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo All participants who received at least a single IV dose of Placebo on Day 1 in either Period 1 or Period 2 or Period 3 as per randomization schedule. 0 None 0 18 10 18 View
GSK3858279 3 mg/kg IV All participants who received at least a single IV dose of GSK3858279 3 mg/kg on Day 1 in either Period 1 or Period 2 or Period 3 as per randomization schedule. 0 None 0 19 12 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Vaccination site pain SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Application site warmth SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Catheter site bruise SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.0 View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Urine output increased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.0 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.0 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders 24.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders 24.0 View
Vaccination complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders 24.0 View