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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:47 PM
NCT ID: NCT00797667
Description: All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
Frequency Threshold: 5
Time Frame: up to 14 days after last dose of study drug (up to 12 weeks)
Study: NCT00797667
Study Brief: MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MK-0974 280 mg Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks None None 3 265 73 265 View
MK-0974 140 mg Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks None None 4 263 61 263 View
Placebo Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks None None 1 128 30 128 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colonic atony SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Labyrinthitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Cerebellar syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Coordination abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View