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 @ 12:24 PM
Ignite Modification Date: 2025-12-25 @ 12:04 PM
NCT ID: NCT00791661
Description: The same participant may appear in more than one treatment arm.
Frequency Threshold: 5
Time Frame: None
Study: NCT00791661
Study Brief: MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
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-1006 15 mg Participants received a single dose of MK-1006 15 mg None None 0 6 1 6 View
MK-1006 30 mg Participants received a single dose of MK-1006 30 mg None None 0 6 1 6 View
MK-1006 45 mg Participants received a single dose of MK-1006 45 mg None None 0 6 0 6 View
MK-1006 60 mg Participants received a single dose of MK-1006 60 mg None None 0 6 1 6 View
MK-1006 60 mg Fed Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast None None 0 6 1 6 View
MK-1006 80 mg Participants received a single dose of MK-1006 80 mg None None 0 6 3 6 View
MK-1006 100 mg Participants received a single dose of MK-1006 100 mg None None 0 6 1 6 View
MK-1006 140 mg Participants received a single dose of MK-1006 140 mg None None 0 4 1 4 View
MK-1006 170 mg Participants received a single dose of MK-1006 170 mg None None 0 5 1 5 View
Placebo Fed Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast None None 0 2 1 2 View
Placebo Participants received matching placebo to MK-1006 None None 0 15 1 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Distension None Gastrointestinal disorders MedDRA 11.0 View
Abdominal tenderness None Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea None Gastrointestinal disorders MedDRA 11.0 View
Periodontitis None Gastrointestinal disorders MedDRA 11.0 View
Nasopharyngitis None Infections and infestations MedDRA 11.0 View
Headache None Nervous system disorders MedDRA 11.0 View
Oropharyngeal pain None Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Blood triglycerides increased None Investigations MedDRA 11.0 View