Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-25 @ 1:47 AM
Ignite Modification Date: 2025-12-26 @ 12:05 AM
NCT ID: NCT02762994
Description: The safety analysis included the data from all patients received at least one dose of BCD-085/placebo. 3 patients were removed from the safety analysis because they recalled their informed consent before the first dose. Aggravation, worsening, and symptoms of the plaque psoriasis were not reportable as AEs. If hospitalization was due to aggravation or worsening of psoriasis it was not reportable as an SAE.
Frequency Threshold: 0
Time Frame: 4 month
Study: NCT02762994
Study Brief: International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
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-085, 40 mg Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 0 None 0 31 14 31 View
BCD-085, 80 mg Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 0 None 0 30 11 30 View
BCD-085, 120 mg Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 0 None 0 28 7 28 View
Placebo Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Placebo 0 None 0 28 11 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ARVI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjuctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ESR increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Total bilirubin increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
GGT increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
AST increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
ALT increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Arterial BP increased SYSTEMATIC_ASSESSMENT Vascular disorders None View
Systolic BP increased SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
LDH increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flu-like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View