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 @ 4:21 PM
Ignite Modification Date: 2025-12-25 @ 2:17 PM
NCT ID: NCT01462266
Description: None
Frequency Threshold: 5
Time Frame: Up to Week 24 + 14-day follow-up
Study: NCT01462266
Study Brief: Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sitagliptin Sitagliptin 100 mg administered orally once daily for 24 weeks. None None 13 329 121 329 View
Placebo Placebo to sitagliptin administered orally once daily for 24 weeks. None None 12 329 168 329 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 16.0 View
Appendicitis perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Monarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Spermatocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Status asthmaticus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View