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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:09 PM
NCT ID: NCT02037256
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT02037256
Study Brief: Bortezomib and Filgrastim to Promote Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A Treatment (Bortezomib and Filgrastim) GROUP A Pts. receive filgrastim SC on days 1-8 \& receive bortezomib IV over 3-5 seconds on days 4 \& day 7, before administration of filgrastim. Pts. undergo apheresis on days 5-8 bortezomib: Given IV filgrastim: Given SC autologous hematopoietic stem cell transplantation: Under 0 None 0 6 6 6 View
B Treatment (Bortezomib and Filgrastim) Group B Pts receive filgrastim SC on days 1-8 and receive bortezomib IV over 3-5 seconds on days 4 and day 7 before administraioin of filgrastim. Pts undergo apheresis on days 5-8. 0 None 0 17 17 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Low ionized calcioum SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection 1 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection 2 SYSTEMATIC_ASSESSMENT Infections and infestations None View