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: 2025-12-24 @ 11:50 AM
Ignite Modification Date: 2025-12-26 @ 10:20 AM
NCT ID: NCT01704261
Description: The ASaT Population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.
Frequency Threshold: 5
Time Frame: Up to Week 27
Study: NCT01704261
Study Brief: Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Omarigliptin Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \>=1500 mg per day). None None 3 153 29 153 View
Placebo Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \>=1500 mg per day). None None 5 153 23 153 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 17.1 View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 17.1 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Cerebrovascular disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View