Description:

NSABP B-35 ADVERSE EVENT FORM (AE) Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy NCT00053898 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A056A959-00D2-32FA-E034-080020C9C0E0

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A056A959-00D2-32FA-E034-080020C9C0E0

Keywords:
Versions (3) ▾
  1. 8/26/12
  2. 3/23/15
  3. 9/20/21
Uploaded on:

September 20, 2021

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License:
Creative Commons BY-NC 3.0 Legacy
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Breast Cancer DCIS NCT00053898

Instructions: Use NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to report all grade 2, 3, 4, or 5 adverse events (AEs). To access the CTCAE, go to the NCI/CTEP web site: http://ctep.cancer.gov. Submit Form AE to the NSABP Biostatistical Center every 6 months during tamoxifen/anastrozole therapy and 6 months after the last administered dose. There should be no time lapse or overlap of dates between the Reporting Period End Date from the previous Form AE and the Reporting Period Start Date of the current Form AE.

Header
Are data amended? (If Yes, circle the amended items in red.)
Any grade 2, 3, 4 or 5 Adverse Event?
Was the patient hospitalized for 24 hours or more? (If "Yes", attach supporting documentation)
Adverse event
Adverse Event
Grade (highest grade this cycle INCLUDE GRADE 0's)

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