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 @ 1:07 AM
NCT ID: NCT05167734
Description: Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
Frequency Threshold: 0
Time Frame: Adverse events were collected from baseline through approximately 3-months after hospitalization.
Study: NCT05167734
Study Brief: Practical Anemia Bundle for SusTained Blood Recovery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anemia Treatment Bundle The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease). Iron Dextran: 1000 mg IV Erythropoietin (EPO): 40,000 units subcutaneous 3 None 1 49 4 49 View
Control (Standard of Care) Group Subjects received standard clinical care for the treatment of anemia while in the ICU. 2 None 3 51 5 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bloodstream Infection SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous Thromboembolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Venous thromboembolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View