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 @ 12:38 AM
Ignite Modification Date: 2025-12-25 @ 10:49 PM
NCT ID: NCT00802867
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected for 6 months post-vaccination.
Study: NCT00802867
Study Brief: Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
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® Vaccine Group Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03. None None 10 989 49 989 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Idiopathic thrombocytopenic purpura NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Gastroenteritis nos NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Pneumonia nos NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6.0 View
Obstructive sleep apnoea syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6.0 View
Asthma nos NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Tonsillar hypertrophy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View