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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:48 PM
NCT ID: NCT04027803
Description: None
Frequency Threshold: 5
Time Frame: 82 days
Study: NCT04027803
Study Brief: Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BCD-148 39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5 0 None 0 39 28 39 View
Soliris 39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5 0 None 0 39 31 39 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
prothrombin time increased SYSTEMATIC_ASSESSMENT Investigations None View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
lymphocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
monocytes count increase SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
platelet count decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ESR increase SYSTEMATIC_ASSESSMENT Investigations None View
INR decrease SYSTEMATIC_ASSESSMENT Investigations None View
prothrombin time decreased SYSTEMATIC_ASSESSMENT Investigations None View
eosinophils count increase SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View