NSABP B-35 Form ALERT NCT00053898 Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy Source Form: NCI FormBuilder:



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September 20, 2021


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NSABP B-35 Form ALERT NCT00053898

Form ALERT Instructions: *Use NCI's Common Toxicity Criteria (CTC) Version 2.0 to assess the adverse event (AE). *Report any grade 3 unexpected AE, or any grade 4 AE, or any grade 5 AE (as listed below). *Complete and FAX this form with all available supporting documentation to the NSABP Biostatistical Center (412/624-1082) within 24 hours of learning about the AE. *Report the AE regardless of attribution (relationship) to protocol therapy (tamoxifen/anastrozole). *Do not fax this report to the NCI, FDA or HPFB.

Patient Demographics
Are data amended? (If Yes, circle the amended items in red.)
AE Evaluation
Notify Local IRB?
Specify Type of Adverse Event (AE)
Was the patient hospitalized for 24 hours or more?
Attribution (relationship) of the AE to protocol therapy?

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