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 @ 2:29 PM
Ignite Modification Date: 2025-12-25 @ 1:03 PM
NCT ID: NCT00712959
Description: The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
Frequency Threshold: 5.0
Time Frame: Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
Study: NCT00712959
Study Brief: Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: Previous Tdap or Tdap-IPV Recipients Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805) None None 3 361 309 361 View
Group 2: Tdap Vaccine-naïve Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose. None None 1 407 341 407 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arnold-Chiari Malformation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 10.0 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Animal Bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Vaginal Haematoma NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Solicited Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Solicited Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Solicited Injection Site Swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Pharyngolaryngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View