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 @ 9:26 PM
Ignite Modification Date: 2025-12-25 @ 7:11 PM
NCT ID: NCT00314132
Description: None
Frequency Threshold: 5.00
Time Frame: Adverse events data were collected from Day 0 to Month 6 post vaccination.
Study: NCT00314132
Study Brief: Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
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 Participants received a single injection of placebo on Day 0. None None 2 403 124 403 View
ChimeriVax™-JE 4 log10 PFU Vaccine Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0. None None 5 1601 597 1601 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Streptococcal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 7.1 View
Fallopian Tube Cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 7.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Feeling Hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 7.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 7.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 7.1 View
Pharyngolaryngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View