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 @ 10:19 PM
Ignite Modification Date: 2025-12-25 @ 7:52 PM
NCT ID: NCT04344535
Description: Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.
Frequency Threshold: 0
Time Frame: Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.
Study: NCT04344535
Study Brief: Convalescent Plasma vs. Standard Plasma for COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Convalescent Donor Plasma Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally \> 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma. 16 None 8 59 0 59 View
Standard Donor Plasma Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies 5 None 1 15 0 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pulmonary Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Liver Failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hematologic Failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infusion Reaction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):