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 @ 3:22 PM
Ignite Modification Date: 2025-12-25 @ 1:41 PM
NCT ID: NCT00609492
Description: None
Frequency Threshold: 5
Time Frame: Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.
Study: NCT00609492
Study Brief: Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Preterm Group Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age. None None 3 116 71 116 View
Full Term Group Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age. None None 1 129 98 129 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Latent tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Fever (rectal temperature measurement) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Loss of appetite SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View