Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 7:57 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT00483704
Description: The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
Frequency Threshold: 5
Time Frame: Up to 14 days post-dose (up to 6 1/2 months)
Study: NCT00483704
Study Brief: Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Telcagepant 140 mg Participants who received at least one dose of telcagepant 140 mg. None None 8 573 166 573 View
Telcagepant 280 mg Participants who received at least one dose of telcagepant 280 mg. None None 8 543 144 543 View
Placebo Participants who received at least one dose of placebo. None None 4 561 138 561 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Mallory-Weiss syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Hodgkin's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Hemiplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Dysfunctional uterine bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View