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 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT01577732
Description: None
Frequency Threshold: 5
Time Frame: Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).
Study: NCT01577732
Study Brief: Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Infanrix-IPV+Hib Group Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh. 0 None 1 300 211 300 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability/fussiness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Loss of appetite SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View