Description:

NSABP-B-47 Cardiac Report Form (Form CR) 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 NCT01275677 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95D01C7E-6AB6-38AE-E040-BB89AD4351B3

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95D01C7E-6AB6-38AE-E040-BB89AD4351B3
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  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
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January 8, 2015

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01275677 On-Study - NSABP-B-47 Cardiac Report Form (Form CR) - 3162764v1.0

This paper worksheet may be completed to facilitate the entry of the report in NSABP Coordinator Online. Partially completed online forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. Submit the report as soon as possible within 21 days of learning of the event. Submit the required information online whenever any of the following cardiac events occurs in any protocol patient: Signs or symptoms of CHF (i.e., >= grade 2 heart failure or grade >= 3 left ventricular systolic dysfunction) Definite cardiac death defined as any grade 5 AE included in the Cardiac Disorders section of CTCAE v4.0 Sudden death NOS as defined in the General Disorders section of the CTCAE v4.0 >= grade 3 acute coronary syndrome >= grade 3 myocardial infarction

Header
Treatment Status Of Patient At Onset Of Cardiac Event
Treatment Status (Mark the item that corresponds to the patient's treatment status at the time of the cardiac event)
Was therapy for recurrence or second primary cancer initiated before the onset of this cardiac event
Did the patient experience any of the following cardiac events at the specified time point (Mark all that apply to this report.)
Section 1 - Symptoms Suggestive Of Congestive Heart Failure, Even If Chf Was Not Subsequently Confirmed
Type of Confirmatory Assessment
Diagnosis (Group 2B only - If the diagnosis of CHF is confirmed during AC, the initiation of trastuzumab is prohibited Protocol Section 9.6.1)
Section 2 - Definite Or Probable Cardiac Death
Nature of Cardiac Death
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