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 @ 2:08 PM
Ignite Modification Date:
2025-12-25 @ 12:50 PM
NCT ID:
NCT04604795
Description:
All-cause mortality, all non-serious AEs and SAEs were collected in Safety population comprised of all randomized participants who received at least one dose of study treatment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
Frequency Threshold:
0
Time Frame:
All-cause mortality, all non-serious and SAEs were collected up to Day 70 in Part A, up to Day 28 in Part B and up to Day 72 in Part C
Study:
NCT04604795
Study Brief:
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK3915393 in Healthy Participants and to Evaluate the Interaction Between GSK3915393 and Grapefruit Juice and Itraconazole
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 A: Placebo | Participants received a single oral dose of matching placebo on Day 1 in treatment Periods 1, 2 or 4. | 0 | None | 0 | 9 | 1 | 9 | View |
| Part A: GSK3915393 15 mg | Participants received a single oral dose of GSK3915393 15 mg on Day 1 in treatment Period 1. | 0 | None | 0 | 9 | 2 | 9 | View |
| Part A: GSK3915393 60 mg | Participants received a single oral dose of GSK3915393 60 mg on Day 1 in treatment Period 2. | 0 | None | 0 | 9 | 3 | 9 | View |
| Part A: GSK3915393 160 mg | Participants received a single oral dose of GSK3915393 160 mg on Day 1 in treatment Period 4. | 0 | None | 0 | 9 | 1 | 9 | View |
| Part A: GSK3915393 100 mcg IV | Participants received single dose of GSK3915393 100 mcg IV. | 0 | None | 0 | 12 | 4 | 12 | View |
| Part B: Placebo | Participants received placebo matching with GSK3915393 as repeat oral dose for 14 days (dosing frequency twice a day \[BID\] or QD, matched to the frequency of dosing in the concurrent active treatment arm). The impact of food effect on pharmacokinetic (PK) of GSK3915393 was investigated following Ante-Meridiem (AM) dose on three days in all cohort (Day 3=fasted, Day 5= high fat breakfast, Day 7=standard breakfast). | 0 | None | 0 | 10 | 3 | 10 | View |
| Part B: GSK3915393 20 mg (BID) | Participants received GSK3915393 20 mg BID as repeat oral dose for 14 days. The impact of food effect on PK of GSK3915393 was investigated following AM dose on three days in all cohort (Day 3=fasted, Day 5= high fat breakfast, Day 7=standard breakfast). | 0 | None | 0 | 10 | 5 | 10 | View |
| Part B: GSK3915393 80 mg (BID) | Participants received GSK3915393 80 mg BID as repeat oral dose for 14 days. The impact of food effect on PK of GSK3915393 was investigated following AM dose on three days in all cohort (Day 3=fasted, Day 5= high fat breakfast, Day 7=standard breakfast). | 0 | None | 0 | 9 | 1 | 9 | View |
| Part B: GSK3915393 160 mg (QD) | Participants received GSK3915393 160 mg QD as repeat oral dose for 14 days. The impact of food effect on PK of GSK3915393 was investigated following AM dose on three days in all cohort (Day 3=fasted, Day 5= high fat breakfast, Day 7=standard breakfast). | 0 | None | 0 | 9 | 5 | 9 | View |
| Part C: GSK3915393 100 mcg IV | Participants received GSK3915393 100 mcg as IV dose. | 0 | None | 0 | 12 | 5 | 12 | View |
| Part C: GSK3915393 100 mcg+ITZ | Participants received GSK3915393 100 mcg as oral dose in combination with ITZ | 0 | None | 0 | 11 | 2 | 11 | View |
| Part C: GSK3915393 20 mg+ Water | Participants received GSK3915393 20 mg as oral dose in combination with water. | 0 | None | 0 | 11 | 3 | 11 | View |
| Part C: GSK3915393 20 mg+ GFJ | Participants received GSK3915393 20 mg as oral dose in combination with GFJ. | 0 | None | 0 | 12 | 2 | 12 | View |
| Part C: GSK3915393 20 mg+ ITZ | Participants received GSK3915393 20 mg as oral dose in combination with ITZ | 0 | None | 0 | 10 | 2 | 10 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| Nodal rhythm | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Abdominal tenderness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Medical device site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Catheter site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Medical device site dermatitis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Vessel puncture site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Vessel puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Catheter site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Infusion site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Exposure to SARS-CoV-2 | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.0 | View |
| SARS-CoV-2 test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |