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 @ 4:50 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT00868218
Description: Each participant received an AE form which was returned to the clinic 21 days after each vaccination.
Frequency Threshold: 0
Time Frame: AE were solicited for 42 days after vaccination
Study: NCT00868218
Study Brief: Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
7.5µg HA Adjuvanted 7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 None None 0 15 12 15 View
30µg HA Vaccine 30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 None None 0 15 8 15 View
1.5µg HA Adjuvanted 1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 None None 0 15 13 15 View
30µg HA Adjuvanted 30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 None None 0 15 13 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
local or systemic reactions NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View