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 @ 1:52 PM
Ignite Modification Date: 2025-12-25 @ 12:42 PM
NCT ID: NCT00505895
Description: None
Frequency Threshold: 0
Time Frame: The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Study: NCT00505895
Study Brief: FM 140 vs FM100 Study in Patients With 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
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion Fludarabine 30 mg/m\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5. None None 16 23 10 23 View
Fludarabine + Melphalan + Stem Cell Infusion Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5. None None 23 27 8 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Secondary graft failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Total Bilirubin Level Change SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Altered mental status SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Elevated creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Pulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Elevated ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Volume overload SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Dysarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Elevated Alkaline Phosphatase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Elevated ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Lethargy SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View