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 @ 1:19 PM
Ignite Modification Date: 2025-12-25 @ 12:26 PM
NCT ID: NCT00258895
Description: None
Frequency Threshold: 5.0
Time Frame: Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Study: NCT00258895
Study Brief: Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DAPTACEL®-Primed Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study. None None 5 487 62 487 View
Pentacel®-Primed Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study. None None 3 162 55 162 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenic purpura NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6.0 View
Gastroenteritis NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Otitis media NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Pneumonia respiratory syncytial viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6.0 View
Skull fracture NOS NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6.0 View
Staring NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6.0 View
Asthma NOS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6.0 View
Bronchospasm NOS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6.0 View
Crying SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6.0 View
Anorexia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6.0 View
Lethargy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Otitis media NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Upper respiratory tract infection NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Injection site redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View