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: 2025-12-25 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT00594958
Description: None
Frequency Threshold: 2
Time Frame: up to Month 6
Study: NCT00594958
Study Brief: Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IC51 Group A IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches None None 3 212 102 212 View
IC51 Group C IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches None None 5 211 114 211 View
IC51 Group B IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches None None 2 213 124 213 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Herpes Zoster None Infections and infestations None View
Peritonsillar Abscess None Infections and infestations None View
Respiratory Tract Infection None Infections and infestations None View
Renal Colic None Renal and urinary disorders None View
Breast Cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Intracranial Aneurysm None Nervous system disorders None View
Reflux Oesophagitis None Gastrointestinal disorders None View
Acute Abdomen None Gastrointestinal disorders None View
Cholecystitis Acute None Hepatobiliary disorders None View
Erysipelas None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myalgia None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Diarrhoea None Gastrointestinal disorders None View
Pharyngolaryngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Acute Tonsillitis None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Influenza Like Ilness None General disorders None View
Nasopharyngitis None Infections and infestations None View
Rhinitis None Infections and infestations None View
Nausea None Gastrointestinal disorders None View
Fatigue None General disorders None View