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: 2025-12-26 @ 11:08 AM
Ignite Modification Date: 2025-12-26 @ 11:08 AM
NCT ID: NCT01449812
Description: None
Frequency Threshold: 5
Time Frame: Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
Study: NCT01449812
Study Brief: Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
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+Hib/Poliorix 1 Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. 0 None 1 272 157 272 View
Infanrix+Hib/Poliorix 2 Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. 0 None 0 273 164 273 View
Control Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. 0 None 0 280 158 280 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Loss of appetite SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View