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 @ 5:06 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT03693950
Description: None
Frequency Threshold: 0
Time Frame: AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
Study: NCT03693950
Study Brief: The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers
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-066 1 µg/kg Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22. BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg 0 None 0 28 5 28 View
Aranesp 1 µg/kg Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22. Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg 0 None 0 28 16 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
monocytes count increase SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytes count increase SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hematocrit decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemoglobin decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
WBC decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophis count decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
RBC decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View