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 @ 6:37 PM
Ignite Modification Date: 2025-12-25 @ 4:07 PM
NCT ID: NCT03226457
Description: Because of the large volume of multicenter studies reporting on the safety and adverse events of SGLT2 inhibitors, for this trial the focus was on the effects on the coprescription with loop diuretic. Adverse event data were also collected. As a crossover study, the adverse event reporting is separated into the events that occurred on the specific intervention/treatment arms.
Frequency Threshold: 5
Time Frame: For the duration of the participants inclusion in the study to the point of completion e.g. 14 to 16 weeks in the trial, with a further review at 4 weeks following discontinuation of the investigational medicinal product e.g. 18 to 20 weeks in total.
Study: NCT03226457
Study Brief: SGLT2 Inhibition in Combination With Diuretics in 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
Empagliflozin Empagliflozin (SGLT2 inhibitor) 25mg capsules once daily for 6 weeks Empagliflozin 25mg: Empagliflozin (SGLT2 inhibitor) 25 mg once daily for 6 weeks Frusemide: Renal Physiology Test (RPT) days will be performed at week 1 and week 6 on each arm of this crossover trial. On these RPT days participants will undergo oral water loading (15mls/kg) and frequent urination at 30 minute intervals to gain a steady state diuresis. At a set time point, an intravenous bolus of furosemide at a dose of half the participant's usual loop diuretic dose will be administered. 0 None 2 23 1 23 View
Placebo Capsules containing microcrystalline cellulose Ph Eur over encapsulated in a hard gelatine capsule shell to match the active comparator Placebo oral capsule: Capsules containing microcrystalline cellulose Ph Eur over encapsulated in a hard gelatine capsule shell to match the active comparator once daily for 6 weeks Frusemide: Renal Physiology Test (RPT) days will be performed at week 1 and week 6 on each arm of this crossover trial. On these RPT days participants will undergo oral water loading (15mls/kg) and frequent urination at 30 minute intervals to gain a steady state diuresis. At a set time point, an intravenous bolus of furosemide at a dose of half the participant's usual loop diuretic dose will be administered. 0 None 0 23 2 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization with heart failure following discontinuation of investigational medicinal product SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gout SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View