Description:

NSABP-B-47 Protocol Treatment and Adverse Event Form (Form TRTAE) A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node- Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9556EA2E-762A-EB5C-E040-BB89AD4324DE

Link:
https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9556EA2E-762A-EB5C-E040-BB89AD4324DE
Keywords:
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
Uploaded on:

January 8, 2015

DOI:
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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01275677 Toxicity - NSABP-B-47 Protocol Treatment and Adverse Event Form (Form TRTAE) - 3161483v1.0

This paper worksheet may be completed to facilitate the entry of the information in NSABP Coordinator Online. Partially completed online forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. This form will collect information on study therapy and adverse events related to study therapy. Submit Form TRTAE for any cycles where study drugs are administered. Submit Form OFF when it is confirmed that the patient will not begin any study drugs or when the patient permanently discontinues or completes all of the study drugs during chemotherapy, and also when the patient permanently discontinues or completes trastuzumab (if applicable)

Header
Arm 1
Reporting Period (for Groups 1B, 2B)
Arm 2
Reporting Period (for Groups 1B, 2B)
Header
Section 1
Dose
Section 1
Dose
Number of Trastuzumab doses (in this Reporting Period)
Section 1b - Post-chemotherapy Trastuzumab
Did the patient receive trastuzumab during this treatment period
Selected Surgical Complications
Was the patient hospitalized with an adverse event (Hospitalization associated with an adverse event is defined as any hospitalization lasting >= 24 hours or prolongation of an existing hospitalization.)
Adverse Event
Grade
Selected Surgical Complications
Adverse Event
Grade
Selected Surgical Complications
Adverse Event
Grade
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