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: 2025-12-26 @ 11:48 AM
Ignite Modification Date: 2025-12-26 @ 11:48 AM
NCT ID: NCT00303316
Description: The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
Frequency Threshold: 5.00
Time Frame: Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
Study: NCT00303316
Study Brief: Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean 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
DTacP-IPV-Hep B-PRP~T Group Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component \[aP\]), hepatitis B (Hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). None None 3 231 134 231 View
PENTAXIM™ and ENGERIX B® Group Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). None None 1 223 137 223 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Otitis Media Acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 7.1 View
Febrile Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 7.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Solicited Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Solicited Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Solicited Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 7.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 7.1 View
Crying SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 7.1 View