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 @ 8:02 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT00937404
Description: None
Frequency Threshold: 0
Time Frame: Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
Study: NCT00937404
Study Brief: Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in 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
IPV Group Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh. 0 None 0 25 20 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View