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 @ 7:42 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT04390503
Description: Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
Frequency Threshold: 5
Time Frame: Collected from baseline until day 28.
Study: NCT04390503
Study Brief: Convalescent Plasma for Early Treatment of 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
Experimental Arm: Convalescent Plasma Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease. 19 None 39 147 38 147 View
Control Arm: Albumin 5% Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff. 18 None 26 72 17 72 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
arterial thrombosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
pulmonary embolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
venous thrombosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
septic shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pneumoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypothermia SYSTEMATIC_ASSESSMENT Immune system disorders None View
ventilator-associated pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
ketoacidosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
metabolic acidosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View