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 @ 9:59 PM
Ignite Modification Date: 2025-12-25 @ 7:36 PM
NCT ID: NCT00698932
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00698932
Study Brief: Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Saxagliptin 5 mg Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks None None 8 284 18 284 View
Placebo Placebo tablet, once daily( OD) for 24 weeks None None 4 284 22 284 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Anal Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Renal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View