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 @ 10:17 PM
Ignite Modification Date: 2025-12-25 @ 7:51 PM
NCT ID: NCT01973335
Description: Each patient was contacted by phone after 3 months, 6 months, and 12 months. A qualified study nurse assessed whether the patient died or was hospitalized during the previous 3 months. The electronic medical record was used to assess the reason for hospitalizations.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT01973335
Study Brief: Acetazolamide and Spironolactone to Increase Natriuresis in Congestive 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
Acetazolamide/Low-dose Loop Diuretics, Upfront Spironolactone * Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist. * Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist. * Patients receive open-label oral spironolactone at a dose of 25 mg unless serum potassium levels are \>5 mmol/L. 6 None 3 9 6 9 View
High-dose Loop Diuretics, Upfront Spironolactone * Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization. * Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist. * Patients receive open-label oral spironolactone at a dose of 25 mg unless serum potassium levels are \>5 mmol/L. 5 None 5 7 4 7 View
Acetazolamide/Low-dose Loop Diuretics, no Spironolactone * Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist. * Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist. * Spironolactone use is prohibited during the first 72 h, but encouraged at discharge. 5 None 2 9 7 9 View
High-dose Loop Diuretics, no Spironolactone * Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization. * Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist. * Spironolactone use is prohibited during the first 72 h, but encouraged at discharge. 5 None 3 9 5 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospital readmission due to heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Serious hyperkalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Moderate hyperkalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Worsening renal function SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View