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: 2025-12-25 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:08 AM
NCT ID: NCT02329834
Description: An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
Frequency Threshold: 0
Time Frame: Day 0 through Day-19 visit
Study: NCT02329834
Study Brief: Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic 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
IV Furosemide Pharmacokinetic Assessments after a successful IV dosing regimen 0 None 0 16 2 16 View
During Washout or Follow-up During washout or follow-up periods 0 None 0 16 5 16 View
SC Furosemide Pharmacokinetic Assessments after a successful SC dosing regimen 0 None 0 16 10 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Application site edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
BNP elevated SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Peripheral pulse decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Total CK elevated SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Troponin elevated SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View