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 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT00967369
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT00967369
Study Brief: Combination Chemotherapy With or Without Bortezomib in Treating Patients With Classical Hodgkin Lymphoma That Has Returned or Does Not Respond to Prior Treatment.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide) Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP. 0 None 1 10 10 10 View
ICE (Ifosfamide, Carboplatin, Etoposide) Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP. 0 None 1 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Transaminitis SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View