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 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
NCT ID:
NCT04544956
Description:
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
Frequency Threshold:
0
Time Frame:
Up to Study Week 36
Study:
NCT04544956
Study Brief:
A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GSK3228836 300 mg | Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11). | 0 | None | 0 | 12 | 11 | 12 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Injection site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Post procedural discomfort | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Sensory disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | 26.1 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 26.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Creatinine renal clearance decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| SARS-CoV-2 test positive | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Muscle twitching | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 26.1 | View |
| Prostatomegaly | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 26.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |