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:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
NCT ID:
NCT04630002
Description:
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
Frequency Threshold:
5
Time Frame:
All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Study:
NCT04630002
Study Brief:
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 2: GSK3640254 200 mg + ETR 200 mg | Participants received GSK3640254 200 mg tablets once daily along with ETR 200 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 2 of the study. | 0 | None | 0 | 16 | 7 | 16 | View |
| Cohort 1: GSK3640254 200 mg | Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study. | 0 | None | 0 | 19 | 6 | 19 | View |
| Cohort 1: DRV/RTV 600/100 mg | Participants received DRV/RTV 600/100 mg tablets twice daily on Days 12 to 21 in Treatment Period 2 of Cohort 1 of the study. | 0 | None | 0 | 16 | 4 | 16 | View |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study. | 0 | None | 0 | 15 | 5 | 15 | View |
| Cohort 2: GSK3640254 200 mg | Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment period 1 of Cohort 2 of the study. | 0 | None | 0 | 19 | 3 | 19 | View |
| Cohort 2: ETR 200 mg | Participants received ETR 200 mg tablets twice daily on Days 12 to 21 Treatment Period 2 of Cohort 2 of the study. | 0 | None | 0 | 16 | 4 | 16 | View |
| Cohort 3: GSK3640254 200 mg | Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 3 of the study. | 0 | None | 0 | 16 | 1 | 16 | View |
| Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg | Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study. | 0 | None | 0 | 15 | 8 | 15 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Lip swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.1 | View |
| Scleral hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.1 | View |
| Application site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.1 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Vessel puncture site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.1 | View |
| Electrocardiogram T wave inversion | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
| Periorbital oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Dry throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 24.1 | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.1 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Abnormal dreams | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.1 | View |