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 @ 10:33 PM
Ignite Modification Date: 2025-12-25 @ 8:05 PM
NCT ID: NCT01110135
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01110135
Study Brief: Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent 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
Treatment (Chemotherapy and Colony-stimulating Factor) Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until \> 5 x 10\^6 CD34+/kg has been collected. . bendamustine hydrochloride: Given IV dexamethasone: Given PO filgrastim: Given SC leukapheresis: Given IV laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies etoposide: Given IV None None 6 34 34 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension None Vascular disorders None View
Stroke None Nervous system disorders None View
Renal insufficiency None Renal and urinary disorders None View
Atrial fibrillation None Cardiac disorders None View
Neutropenic fever None Blood and lymphatic system disorders None View
Sepsis None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphopenia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Leukopenia None Blood and lymphatic system disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Muscle weakness None Musculoskeletal and connective tissue disorders None View
Hypotension None Vascular disorders None View