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 @ 1:35 PM
Ignite Modification Date: 2025-12-25 @ 12:35 PM
NCT ID: NCT02877095
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02877095
Study Brief: Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
In-patient Pilot Study All subjects in the in-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously. Furosemide: subcutaneous furosemide delivered via subcutaneous pump 0 None 0 20 4 20 View
Out-patient Pilot Study All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously. Furosemide: subcutaneous furosemide delivered via subcutaneous pump 0 None 1 20 8 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Implant site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedRA View
Injection Site discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedRA View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedRA View
Injection site haemorhage NON_SYSTEMATIC_ASSESSMENT General disorders MedRA View
Injection Site Rash NON_SYSTEMATIC_ASSESSMENT General disorders MedRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Muscle spasm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Nervousness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Cardiac Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View