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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT01165112
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01165112
Study Brief: Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma
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 Monoclonal Antibody Therapy) Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Bendamustine Hydrochloride: Given IV Carboplatin: Given IV Rituximab: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies None None 14 48 46 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia None Blood and lymphatic system disorders None View
Catheter related infection None Infections and infestations None View
Obstruction gastric None Gastrointestinal disorders None View
Allergic reaction None Immune system disorders None View
Dehydration None Metabolism and nutrition disorders None View
Fever None General disorders None View
Asthma exacerbation None Respiratory, thoracic and mediastinal disorders None View
Atrial fibrillation None Cardiac disorders None View
Hypotension None Vascular disorders None View
Aseptic Meningitis None Infections and infestations None View
Vascular access complication None Vascular disorders None View
Upper respiratory infection None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Dehydration None Metabolism and nutrition disorders None View
Infection None Infections and infestations None View