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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT02547935
Description: The Safety Analysis Set consisted of all patients who received at least 1 dose of study drug during the 24-week double-blind treatment period.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) are reported from Day 1 of the 24-week double-blind treatment period. Non-serious AEs were included up to the last day of double-blind treatment + 4 days. Serious AEs were included up to the last day of double-blind treatment + 30 days, giving a total maximum time frame of 28 weeks.
Study: NCT02547935
Study Brief: A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dapagliflozin 10 mg + Saxagliptin 2.5 mg Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks. 1 None 12 152 12 152 View
Dapagliflozin 10 mg Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin. 1 None 12 145 18 145 View
Placebo Placebo tablets to match both active products (dapagliflozin and saxagliptin)were taken orally, once daily (in the morning) for 24 weeks. 0 None 16 148 8 148 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Diabetic foot infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Emphysematous pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Genital infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Groin abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia influenzal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Glomerulonephritis rapidly progressive SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Diabetic foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View