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 @ 12:15 AM
Ignite Modification Date: 2025-12-25 @ 10:17 PM
NCT ID: NCT00347958
Description: None
Frequency Threshold: 5.0
Time Frame: Adverse events data were collected from the day of vaccination to 6 months post-vaccination
Study: NCT00347958
Study Brief: Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adacel® Vaccine Group Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518. None None 7 544 479 544 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9.1 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Kidney infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.1 View
Intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.1 View
Malnutrition NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.1 View
Carcinoid tumour of the appendix NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 9.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site erythema/redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Pyrexia (Fever) SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View