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 @ 12:04 AM
Ignite Modification Date: 2025-12-25 @ 10:03 PM
NCT ID: NCT04415658
Description: Serious adverse event defined as donor instability resulting in cardiac arrest or premature donor loss. Adverse events were collected for each arm combining all study periods, i.e. from study onset through end of donor management (organ recovery). These were not collected for each period (i.e. first 12 hours versus open-label period) separately.
Frequency Threshold: 1
Time Frame: 1 week
Study: NCT04415658
Study Brief: Intravenous Thyroxine for Heart-Eligible Organ Donors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Thyroxine Intravenous thyroxine infusion Thyroxine: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours. Donors were followed till organ recovery or end of management. 419 None 2 419 51 419 View
Saline Placebo Intravenous saline infusion Saline: The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours. Donors were followed till organ recovery or end of management. 419 None 3 419 16 419 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest / donor loss SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular ectopy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Misc/Other SYSTEMATIC_ASSESSMENT General disorders None View