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 @ 12:34 PM
Ignite Modification Date:
2025-12-25 @ 12:10 PM
NCT ID:
NCT03045861
Description:
SAEs and non-serious AEs were collected in the Safety Population
Frequency Threshold:
0
Time Frame:
SAEs and non-serious AEs were collected from the start of study treatment until Day 22
Study:
NCT03045861
Study Brief:
Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GSK2838232 20 mg | Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10. | 0 | None | 0 | 7 | 3 | 7 | View |
| GSK2838232 50 mg | Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10. | 0 | None | 0 | 8 | 3 | 8 | View |
| GSK2838232 100 mg | Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10. | 0 | None | 0 | 10 | 5 | 10 | View |
| GSK2838232 200 mg | Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10. | 0 | None | 0 | 8 | 5 | 8 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Head discomfort | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.0 | View |
| Medical device site dermatitis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.0 | View |
| Medical device site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Abnormal dreams | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |