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 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
NCT ID:
NCT02119260
Description:
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
Frequency Threshold:
5
Time Frame:
On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
Study:
NCT02119260
Study Brief:
A First Time in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Healthy Subjects and Stable Heart Failure Patients
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 1 | Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort. | 0 | None | 0 | 9 | 5 | 9 | View |
| Cohort 2 | Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability. | 0 | None | 0 | 12 | 7 | 12 | View |
| Cohort 3 | Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension) | 0 | None | 0 | 8 | 6 | 8 | View |
| Cohort 4 | Participants with heart failure received single oral and subsequent 7-days repeat-dose evaluation of GSK2798745 2.4 mg or placebo in capsule formulation | 0 | None | 0 | 23 | 22 | 23 | View |
| Cohort 5 | Participants with heart failure received repeat-doses of GSK2798745 2.4 mg or placebo in capsule formulation | 0 | None | 0 | 8 | 8 | 8 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.1 | View |
| Migraine with aura | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | 19.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.1 | View |
| Scab | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 19.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.1 | View |
| Lip blister | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.1 | View |
| Catheter site bruise | SYSTEMATIC_ASSESSMENT | General disorders | 19.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 19.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 19.1 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.1 | View |
| Oropharyngeal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.1 | View |
| Ear disorder | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 19.1 | View |
| Blepharospasm | SYSTEMATIC_ASSESSMENT | Eye disorders | 19.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.1 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 19.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 19.1 | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 19.1 | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | 19.1 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 19.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 19.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 19.1 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 19.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.1 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | 19.1 | View |
| Audiogram abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 19.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 19.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 19.1 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.1 | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.1 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 19.1 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.1 | View |
| Skin burning sensation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 19.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 19.1 | View |
| Gastrointestinal sounds abnormal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.1 | View |
| Hyperaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | 19.1 | View |