All patients who received ≥1 dose of pralatrexate were evaluable for safety, which was assessed by reported AEs, laboratory assessments, and physical examinations, and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events scale, version 4.03. AEs were characterized by intensity (severity), causality, and seriousness by the investigator and recorded from the first dose of pralatrexate until at least 30 days after the last dose.
Protocol detail
Safety Evaluation of Pralatrexate Treatment
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Corresponding Organization :
Other organizations : The University of Texas MD Anderson Cancer Center, Mayo Clinic in Arizona, Hospital of the University of Pennsylvania, Fox Chase Cancer Center
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Variable analysis
independent variables
- Pralatrexate dose (≥1 dose)
- Adverse events (AEs) reported
- Laboratory assessments
- Physical examinations
- Adverse event intensity (severity)
- Adverse event causality
- Adverse event seriousness
- National Cancer Institute Common Terminology Criteria for Adverse Events scale, version 4.03
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