Description:

E5103 Adverse Event Form (CTCAE v3) NCT00433511 Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=22B14F38-EFAA-6454-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=22B14F38-EFAA-6454-E044-0003BA3F9857

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Versions (5) ▾
  1. 8/26/12
  2. 1/8/15
  3. 1/9/15
  4. 1/9/15
  5. 7/8/15
Uploaded on:

July 8, 2015

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License:
Creative Commons BY-NC 3.0 Legacy
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E5103 Adverse Event Form (CTCAE v3) NCT00433511

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

ECOG clinical trial administrative data
Patient demographics
Data amendment
Reporting Period
On Treatment Report Period (STEP 2 - ARM D ONLY)
Off Treatment Reporting Period
Off Treatment Report Period
Adverse Events
Were adverse events assessed during this report period (cycle)
I. METABOLIC - LABS
CTC Adverse Event Term
CTC AE Attribution Code
Action taken for this AE for Chemotherapy
Action taken for this AE for Bevacizumab (/placebo)
II. NON-HEMATOLOGIC
III. NON-HEMATOLOGIC (GRADE 2-5)
CTC Adverse Event Short Name (Specify site for each event)
IV. Other Adverse Events (GRADE 3-5)
V. INFECTIONS
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