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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:10 PM
NCT ID: NCT03078556
Description: Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
Frequency Threshold: 5
Time Frame: AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Study: NCT03078556
Study Brief: Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
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- A: DTG 50 mg + EPIVIR 300 mg Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. 0 None 0 75 2 75 View
Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. 0 None 0 76 5 76 View
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. 0 None 0 16 1 16 View
Part 2- A: DTG 50 mg + EPIVIR 300 mg Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. 0 None 0 75 8 75 View
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. 0 None 0 75 6 75 View
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. 0 None 0 16 1 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View