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: NCT03030235
Description: Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Frequency Threshold: 0
Time Frame: Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period.
Study: NCT03030235
Study Brief: Dapagliflozin in PRESERVED Ejection Fraction Heart Failure
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 Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet 1 None 31 162 13 162 View
Placebo Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo 2 None 22 162 16 162 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Critical Limb Ischemia SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elective Watchman Device Implantation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated Troponin in the setting of Covid-19 SYSTEMATIC_ASSESSMENT General disorders None View
Exacerbation of Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT General disorders None View
Exacerbation of Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Eye disorders None View
Gastrointestinal bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematuria SYSTEMATIC_ASSESSMENT General disorders None View
Hemochromatosis SYSTEMATIC_ASSESSMENT General disorders None View
Hemoptysis SYSTEMATIC_ASSESSMENT General disorders None View
Hypercapnic and hypoxic respiratory failure requiring intubation SYSTEMATIC_ASSESSMENT General disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT General disorders None View
Infected right great toe SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza A SYSTEMATIC_ASSESSMENT Infections and infestations None View
Iron Overload cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left hilar mass SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Left hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Liver failure/Cirrhosis leading to Hepatic/Metabolic Encephalopathy SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Melena and hematochezia SYSTEMATIC_ASSESSMENT General disorders None View
Multiple Abscesses SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Osteoarthritis (Right Hip) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteomyelitis (left foot) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Parainfluenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Aortic Ulcer SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Prostate Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal failure leading to endstage renal disease requiring dialysis SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Wall Hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT General disorders None View
Acute Renal Failure SYSTEMATIC_ASSESSMENT General disorders None View
Acute Respiratory Distress SYSTEMATIC_ASSESSMENT General disorders None View
Acute Right Cerebellar Infarct SYSTEMATIC_ASSESSMENT General disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ascites of the Abdomen SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Benign Paroxysmal Positional Vertigo SYSTEMATIC_ASSESSMENT General disorders None View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Clostridium Difficile SYSTEMATIC_ASSESSMENT Infections and infestations None View
Right leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right Shoulder - Infected Arthroplasty SYSTEMATIC_ASSESSMENT Infections and infestations None View
Salmonella enteritis/diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Schwannoma of spinal cord at L1-L2 SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic Arthritis of the Right Knee SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septicemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Endstage chronic obstructive pulmonary disease with hypoxic and hypercapnic respiratory failure SYSTEMATIC_ASSESSMENT General disorders None View
Suicidal Ideation SYSTEMATIC_ASSESSMENT General disorders None View
Syncope SYSTEMATIC_ASSESSMENT General disorders None View
Type II NSTEMI SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Uncontrolled Hypertension SYSTEMATIC_ASSESSMENT General disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Volume Depletion SYSTEMATIC_ASSESSMENT General disorders None View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT General disorders None View
Worsening Osteoarthritis - Left Knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Volume Depletion SYSTEMATIC_ASSESSMENT General disorders None View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Urgent Heart Failure Visit SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastrointestinal intolerance SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT General disorders None View
Blurry vision SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT General disorders None View
Foul smelling urine SYSTEMATIC_ASSESSMENT General disorders None View
Sense of hopelessness SYSTEMATIC_ASSESSMENT General disorders None View