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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT01353703
Description: None
Frequency Threshold: 5
Time Frame: Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 to Month 3 or Month 5).
Study: NCT01353703
Study Brief: Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/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 Hexa 6-10-14 Group Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. 0 None 2 112 45 112 View
Infanrix Hexa 2-4-6 Group Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. 0 None 3 112 36 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View