Adverse Events Module

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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 @ 10:56 PM
Ignite Modification Date: 2025-12-25 @ 8:24 PM
NCT ID: NCT04507269
Description: None
Frequency Threshold: 0
Time Frame: Up to 48 weeks after the first dose of VIR-2218 or placebo
Study: NCT04507269
Study Brief: Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China
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 1: VIR-2218 50 mg HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart 0 None 0 4 1 4 View
Part 1: VIR-2218 100 mg 100 mg HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart 0 None 0 4 2 4 View
Part 1: Placebo HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart 0 None 0 3 0 3 View
Part 2: VIR-2218 50 mg HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart 0 None 0 4 2 4 View
Part 2: VIR-2218 100 mg HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart 0 None 0 4 1 4 View
Part 2: Placebo HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart 0 None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 24.1 View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 24.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 24.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 24.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 24.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 24.1 View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 24.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 24.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 24.1 View