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: 2025-12-26 @ 10:19 PM
Ignite Modification Date: 2025-12-26 @ 10:19 PM
NCT ID: NCT00604812
Description: None
Frequency Threshold: 4
Time Frame: None
Study: NCT00604812
Study Brief: Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rizatriptan 5 mg Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. None None 0 10 3 10 View
Rizatriptan 10 mg Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. None None 0 14 7 14 View
Placebo Combined Placebo groups from panels A, B, and C. None None 0 7 3 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bruising of arm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Earache SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Visual disturbance SYSTEMATIC_ASSESSMENT Eye disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Tiredenss SYSTEMATIC_ASSESSMENT General disorders None View
Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Painful left arm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elevation in blood pressure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View