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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:38 AM
NCT ID: NCT01296360
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01296360
Study Brief: Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Booster Group IC51 booster vaccination \~12 months after primary immunization in study IC51-323 None None 7 150 99 150 View
Non-Booster Group No treatment in study IC51-325 None None 3 150 100 150 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary tract infection None Infections and infestations None View
Finger amputation None Surgical and medical procedures None View
Amoebic dysentery None Infections and infestations None View
Bronchopneumonia None Infections and infestations None View
Dengue fever None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Concussion None Injury, poisoning and procedural complications None View
Injury None Injury, poisoning and procedural complications None View
Pneumothorax traumatic None Injury, poisoning and procedural complications None View
Paralysis None Nervous system disorders None View
Abscess None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Varicella None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Rhinitis None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Impetigo None Infections and infestations None View
Viral infection None Infections and infestations None View
Pyrexia None General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View