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 @ 3:03 PM
Ignite Modification Date: 2025-12-25 @ 1:26 PM
NCT ID: NCT00413959
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00413959
Study Brief: VELCADE,Rituximab,Cyclophosphamide and Decadron
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Velcade, Rituximab,Cyclophosphamide & Decadron Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle. None None 2 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Congestive Heart Failure None Cardiac disorders None View
Cerebral Vascular Accident None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety Grade 1 & 2 None General disorders None View
Abdominal Pain Grade 1 & 2 None Gastrointestinal disorders None View
Appetite Decreased Grade 1 & 2 None Gastrointestinal disorders None View
Bilirubin Increased Grade 1 & 2 None Renal and urinary disorders None View
Alopecia Grade 1 & 2 None General disorders None View
Creatinine Increased Grade 1 & 2 None Renal and urinary disorders None View
Constipation Grade 1 & 2 None Gastrointestinal disorders None View
Cough Grade 1 & 2 None Respiratory, thoracic and mediastinal disorders None View
Chills Grade 1 & 2 None General disorders None View
Edema Grade 1 & 2 None General disorders None View
Fever Grade 1 & 2 None General disorders None View
Fatigue Grade 1 & 2 None General disorders None View
Hyponatremia Grade 1 & 2 None Gastrointestinal disorders None View
Hypertension Grade 1 & 2 None Cardiac disorders None View
Hyperglycemia Grade 1 & 2 None Gastrointestinal disorders None View
Insomnia Grade 1 & 2 None General disorders None View
Leukopenia Grade 1 & 2 None Blood and lymphatic system disorders None View
Rash Grade 1 & 2 None Skin and subcutaneous tissue disorders None View
Nausea Grade 1 & 2 None Gastrointestinal disorders None View
Mucositis Grade 1 & 2 None Gastrointestinal disorders None View
Pulmonary Edema Grade 1 & 2 None Respiratory, thoracic and mediastinal disorders None View
Nail Changes Grade 1 & 2 None Skin and subcutaneous tissue disorders None View
Sweats Grade 1 & 2 None General disorders None View
Dry Skin Grade 1 & 2 None Skin and subcutaneous tissue disorders None View
Stomatitis Grade 1 & 2 None Gastrointestinal disorders None View
Sinus Congestion Grade 1 & 2 None Respiratory, thoracic and mediastinal disorders None View
Tronopin Increased Grade 1 & 2 None Blood and lymphatic system disorders None View
Triglyceride Increased Grade 1 & 2 None General disorders None View
Tongue Swelling Grade 1 & 2 None General disorders None View
Weight Decreased Grade 1 & 2 None Gastrointestinal disorders None View
Tooth Abcess Grade 1 & 2 None General disorders None View
Vomiting Grade 1 & 2 None Gastrointestinal disorders None View
Difficulty Walking Grade 1 & 2 None Musculoskeletal and connective tissue disorders None View
Chest Pain Grade 3 & 4 None Musculoskeletal and connective tissue disorders None View
Hyperglycemia Grade 3 & 4 None Gastrointestinal disorders None View
Leukopenia Grade 3 & 4 None Blood and lymphatic system disorders None View
Neutropenia Grade 3 & 4 None Blood and lymphatic system disorders None View
Orthopnea Grade 3 & 4 None Respiratory, thoracic and mediastinal disorders None View
Pulmonary Edema Grade 3 & 4 None Respiratory, thoracic and mediastinal disorders None View
Pulmonary Emboli Grade 3 & 4 None Respiratory, thoracic and mediastinal disorders None View
Shortness of Breath Grade 3 & 4 None Respiratory, thoracic and mediastinal disorders None View
Headache Grade 1 & 2 None General disorders None View
Pain Grade 1 & 2 None General disorders None View