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 @ 11:48 AM
Ignite Modification Date: 2025-12-26 @ 11:48 AM
NCT ID: NCT00412516
Description: Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Frequency Threshold: 5
Time Frame: Three years post vaccination
Study: NCT00412516
Study Brief: Determining Long-Term Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 SA 14-14-2 followed by measles vaccine one month later None None 4 93 0 0 View
Group 2 Measles and SA 14-14-2 given concurrently Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group) None None 14 212 0 0 View
Group 3 Measles vaccine followed by SA 14-14-2 one month later None None 13 214 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lobar pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Developmental delay NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Amoebiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Ascariasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Cholera NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Dengue Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Meningitis tuberculous NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Skull fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Food intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (Unspecified) View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Other Events(If Any):