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 @ 2:24 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT02712359
Description: Only SAEs related to study procedures were collected during the entire study period. There were no other adverse events (AEs) data collected during the entire study period.
Frequency Threshold: 0
Time Frame: SAEs: Epoch 001: from Visit at Year 8 (the time of sample collection) up to study conclusion (i.e. during an approximate period of 15 months); Epoch 002: from Visit at Year 10 (the time of sample collection) up to study conclusion (i.e. during an approximate period of 8 months).
Study: NCT02712359
Study Brief: This Study Will Evaluate the Persistence of Hepatitis A Antibodies, 8 Years and 10 Years Later, in Children Who Had Received Havrix at Selected Health Centres of Panama
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Havrix 1 dose_Year 8 Group Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey. 0 None 0 300 0 0 View
Havrix 2 doses_Year 8 Group Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey. 0 None 0 300 0 0 View
Havrix 1 dose_Year 10 Group Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey. 0 None 0 299 0 0 View
Havrix 2 doses_Year 10 Group Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey. 0 None 0 300 0 0 View
Serious Events(If Any):
Other Events(If Any):