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 @ 4:47 PM
Ignite Modification Date: 2025-12-25 @ 2:33 PM
NCT ID: NCT02526550
Description: Patients' parents/guardians were provided with rulers, digital thermometers, and diary cards to record daily temperature and any solicited local injection site reactions (pain, redness, and swelling) and general symptoms (fever, abnormal crying/irritability, drowsiness, loss of appetite and skin rash) during the 28-day period following each study vaccination. The occurrence of unsolicited (i.e. spontaneously reported) adverse events were recorded for up to 28 days following vaccination.
Frequency Threshold: 0
Time Frame: 28 days following vaccination
Study: NCT02526550
Study Brief: Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Imojev Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh None None 0 49 31 49 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Immediate reactions SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Solicited local reactions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Solicited systemic reactions SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Unsolicited adverse events SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View