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 @ 1:59 PM
Ignite Modification Date: 2025-12-25 @ 12:45 PM
NCT ID: NCT03827395
Description: None
Frequency Threshold: 5
Time Frame: Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Study: NCT03827395
Study Brief: Safety Study of Hepatitis E Vaccine (HEV239)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180. 0 None 1 5 5 5 View
HEV-239 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180. 0 None 0 20 19 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dysmenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (23.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrooesophageal Reflux Disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.1) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.1) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.1) View
Injection Site Haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.1) View
Injection Site Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.1) View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.1) View
Injection Site Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.1) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.1) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.1) View
Skin Abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (23.1) View
Sunburn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (23.1) View
Thermal Burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (23.1) View
Blood Creatinine Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (23.1) View
Haemoglobin Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (23.1) View
Heart Rate Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (23.1) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (23.1) View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (23.1) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.1) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (23.1) View
Initial Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (23.1) View
Oropharyngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.1) View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.1) View
Rosacea NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (23.1) View