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: 2025-12-26 @ 3:59 PM
Ignite Modification Date: 2025-12-26 @ 3:59 PM
NCT ID: NCT02862106
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT02862106
Study Brief: Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for 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
Follow-up Group Do not give any intervention, follow-up observation only All safety analyzes were analyzed in a safe population, and since 1 subjects had no safety data, they were excluded from the safety population None None 0 25 2 25 View
εPA-44 900μg Group Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 All safety analyzes were analyzed in a safe population, and since 5 subjects had no safety data, they were excluded from the safety population None None 5 178 43 178 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Chronic nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Severe chronic hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Acute exacerbation of Chronic hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
weakness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
ALT increased SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
AST increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Leukocytes in urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Elevated transaminase SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Mouth ulcers SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gum pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gingival swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View