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 @ 3:45 AM
Ignite Modification Date: 2025-12-26 @ 2:32 AM
NCT ID: NCT00619502
Description: None
Frequency Threshold: 5.00
Time Frame: Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
Study: NCT00619502
Study Brief: Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish 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
DTaP-IPV-HepB-PRP~T All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study. None None 4 130 56 130 View
Pentaxim™ + Engerix B™ All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study. None None 2 124 67 124 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Poisoning NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Crying SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View