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 @ 1:10 AM
Ignite Modification Date: 2025-12-25 @ 11:21 PM
NCT ID: NCT01153893
Description: Because of an issue discovered with the informed consent obtained for one child after the original statistical analysis. The data of the child, who also had an SAE that was not considered to be related to the study medication by the investigator, have been removed from the results tables.
Frequency Threshold: 5
Time Frame: Solicited AEs: Within 4 days (Days 0-3) after vaccination. Unsolicited AEs: Within 31 days (Days 0-30) after vaccination. SAEs: From Day 0 up to Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.
Study: NCT01153893
Study Brief: Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Synflorix/Infanrix Unprimed Group Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm. None None 0 36 25 36 View
Synflorix/Infanrix Primed Group Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm. None None 1 68 46 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Drowning NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Malaria NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Furuncle NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View