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 @ 2:49 PM
Ignite Modification Date: 2025-12-25 @ 1:17 PM
NCT ID: NCT01619059
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01619059
Study Brief: Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes
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 + Dapagliflozin 10mg + Metformin Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks None None 11 162 37 162 View
Saxagliptin 5mg + Dapagliflozin 10mg + Metformin Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks None None 7 153 37 153 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANGINA PECTORIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.1 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.1 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.1 View
RETINAL DETACHMENT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.1 View
COLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
HERNIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 17.1 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
STAPHYLOCOCCUS TEST POSITIVE SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.1 View
RHABDOMYOLYSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
HEPATIC CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 17.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
UTERINE HAEMORRHAGE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 17.1 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
DIABETIC FOOT SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View
SKIN ULCER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View
PERIPHERAL ARTERY THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.1 View
PERIPHERAL VASCULAR DISORDER SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View