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 @ 10:41 PM
Ignite Modification Date: 2025-12-25 @ 8:12 PM
NCT ID: NCT00700635
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
Study: NCT00700635
Study Brief: Dose Comparison Study of Menactra® in US Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Menactra® Group 1 Participants aged 2 to less than 4 years who received 2 doses of vaccine None None 4 111 58 111 View
Menactra® Group 2 Participants aged 4 to less than 6 years who received 2 doses of vaccine None None 3 111 57 111 View
Menactra® Group 3 Participants aged 6 to less than 11 years who received a single dose of vaccine None None 0 111 64 111 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Periorbital cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Breath holding NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Bronchial hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site erythma SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Anorexia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Rhinorrhea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Injection site induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View