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 @ 2:54 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT01323959
Description: None
Frequency Threshold: 5
Time Frame: Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
Study: NCT01323959
Study Brief: Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted 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
Boostrix Polio Group Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. None None 0 67 52 67 View
Boostrix+Poliorix Group Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. None None 0 72 54 72 View
Revaxis Group Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. None None 0 72 54 72 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Gastrointestinal symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View