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 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
NCT ID:
NCT02981602
Description:
Non-serious and serious adverse events were collected in the Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
Frequency Threshold:
5
Time Frame:
Non-serious (>=5%) and serious adverse events were collected up to Day 211
Study:
NCT02981602
Study Brief:
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection
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 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | 0 | None | 1 | 12 | 6 | 12 | View |
| Cohorts 1-3 Placebo | Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. | 0 | None | 0 | 6 | 2 | 6 | View |
| Cohort 4 GSK3228836 300 mg | Participants on stable nucleos(t)ide treatment were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | 0 | None | 0 | 5 | 3 | 5 | View |
| Cohort 4 Placebo | Participants on stable nucleos(t)ide treatment were subcutaneously administered placebo on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | 0 | None | 0 | 2 | 0 | 2 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA19.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA19.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA19.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA19.1 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA19.1 | View |
| Injection site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA19.1 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA19.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.1 | View |
| Mouth swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA19.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA19.1 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA19.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA19.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA19.1 | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA19.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA19.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.1 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA19.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA19.1 | View |
| Hand-foot-and-mouth disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.1 | View |
| Post inflammatory pigmentation change | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA19.1 | View |