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 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
NCT ID:
NCT04423393
Description:
None
Frequency Threshold:
5
Time Frame:
Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
Study:
NCT04423393
Study Brief:
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus 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 |
|---|---|---|---|---|---|---|---|---|
| Part A: Healthy Participants 3000 mg IV | Healthy participants received 3000 mg VIR-3434 intravenously | 0 | None | 0 | 6 | 3 | 6 | View |
| Part C: HBV Participants Placebo | HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous | 0 | None | 0 | 6 | 4 | 6 | View |
| Part D: HBV Participants 75 mg SC | HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 2 | 6 | View |
| Part A: Healthy Participants 90 mg SC | Healthy participants received 90 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 4 | 6 | View |
| Part A Healthy Participants 300 mg SC | Healthy participants received 300 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 4 | 6 | View |
| Part A Healthy Participants 900 mg SC | Healthy participants received 900 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 5 | 6 | View |
| Part A Healthy Participants 900 mg IV | Healthy Participants received 900 mg VIR-3434 intravenously | 0 | None | 0 | 6 | 4 | 6 | View |
| Part A Healthy Participants Placebo | Healthy participants received placebo subcutaneously or intravenously | 0 | None | 0 | 11 | 6 | 11 | View |
| Part B: HBV Participants 6 mg SC | HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 0 | 6 | View |
| Part B: HBV Participants 18 mg SC | HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 1 | 6 | View |
| Part B: HBV Participants 75 mg SC | HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 2 | 6 | View |
| Part B: HBV Participants 300 mg SC | HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 3 | 6 | View |
| Part B: HBV Participants Placebo | HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous | 0 | None | 0 | 8 | 2 | 8 | View |
| Part C: HBV Participants 18 mg SC | HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 2 | 6 | View |
| Part C: HBV Participants 75 mg SC | HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 4 | 6 | View |
| Part C: HBV Participants 300 mg SC | HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous | 0 | None | 1 | 6 | 5 | 6 | View |
| Part D: HBV Participants 300 mg SC | HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous | 0 | None | 0 | 6 | 6 | 6 | View |
| Part D: HBV Participants Placebo | HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous | 0 | None | 0 | 4 | 1 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaphylactic Reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |