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 @ 5:06 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT00944450
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00944450
Study Brief: Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods. None None 0 12 3 12 View
100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous 100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation) None None 0 12 5 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Thermal Burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Musculoskeletal Stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View