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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT00305604
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00305604
Study Brief: Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Sitagliptin-matching placebo tablets. None None 14 None 6 None View
Sitagliptin Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \< 50 mL/min at any time during the study. None None 7 None 4 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Any Cardiac disorders NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Coronary Artery Disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Angina Pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Any Gastrointestinal disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Gastroesophageal Reflux Disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Lower Gastrointestinal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Any Hepatobiliary disorders NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Any Infections and infestations NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Mycobacterium Avium Complex Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Staphylococcal Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Any Injury, poisoning and procedural complications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.1 View
Lumbar Vertebral Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.1 View
Upper Limb Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.1 View
Any Metabolism and nutrition disorders NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Any Neoplasms benign, malignant and unspecified NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Basal Cell Carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Colon Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Malignant Melanoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Squamous Cell Carcinoma Of Skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Any Renal and urinary disorders NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Bladder Obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Renal Failure Acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Any Reproductive system and breast disorders NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.1 View
Pelvic Pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.1 View
Any Respiratory, thoracic and mediastinal disorders NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Any Infections and Infestations NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View