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 @ 3:20 PM
Ignite Modification Date: 2025-12-25 @ 1:40 PM
NCT ID: NCT04857892
Description: Safety Population consisted of all participants who received at least one dose of study intervention.
Frequency Threshold: 5
Time Frame: All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Study: NCT04857892
Study Brief: A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3. 0 None 0 22 0 22 View
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3. 0 None 0 21 0 21 View
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3. 0 None 0 20 1 20 View
Part 2: Treatment D: GSK3640254/DTG, 150 mg/50 mg (Fed) Participants received Treatment D a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg under high fat and calorie conditions on Day 1 in each treatment period. 0 None 0 17 1 17 View
Part 2: Treatment E: GSK3640254/DTG, 150 mg/50 mg (Fasted) Participants received Treatment E a single oral dose of selected bilayer FDC from Part 1 GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in each treatment period. 0 None 0 18 2 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View