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 @ 9:58 PM
Ignite Modification Date: 2025-12-25 @ 7:36 PM
NCT ID: NCT01545232
Description: None
Frequency Threshold: 0
Time Frame: up to 30 days following ED admission
Study: NCT01545232
Study Brief: Pragmatic, Randomized Optimal Platelet and Plasma Ratios
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1:1:1 Blood Transfusion Ratio 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. None None 2 338 297 338 View
1:1:2 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. None None 4 342 310 342 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Transfusion-associated circulatory overload SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypernatremia associated with hypertonic saline use SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ventilator-associated pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Transfusion-related metabolic complications SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Acute Lung Injury SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute Respiratory Distress Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal Complication SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Multiple Organ Failure SYSTEMATIC_ASSESSMENT General disorders None View
Symptomatic pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Additional bleeding after hemostasis requiring intervention SYSTEMATIC_ASSESSMENT General disorders None View
Asymptomatic pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal Compartment syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Delayed serological transfusion reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Transfusion-related allergic reaction SYSTEMATIC_ASSESSMENT General disorders None View
Febrile nonhemolytic transfusion reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View