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: 2025-12-25 @ 12:04 AM
Ignite Modification Date: 2025-12-25 @ 10:02 PM
NCT ID: NCT01133158
Description: None
Frequency Threshold: 5
Time Frame: 9 years
Study: NCT01133158
Study Brief: R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv Patients with response will receive Rituximab in maintenance: 375 mg / m2 every three months 1 None 22 60 60 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Left ventricular systolic dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Leucoencephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Progression suspicion NON_SYSTEMATIC_ASSESSMENT Investigations None View
Oral ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hepatic insufficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Immunodeficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neuropathy caranial-CN VII NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pleural effussion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
mucositis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cold NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
mood alteration NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
pruritus/itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hearing NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
dispnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
plateletes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Metabolic/laboratory NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View