Description:

E1305 Adverse Event Form (CTCAE v4) NCT00588770 Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19FB3923-297D-35D3-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19FB3923-297D-35D3-E044-0003BA3F9857

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  1. 9/19/12
  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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E1305 Adverse Event Form (CTCAE v4) NCT00588770

INSTRUCTIONS: Complete this form as indicated below and at the end of all protocol therapy. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

ECOG clinical trial administrative data
Patient demographics
Data amendment
On Treatment
On Treatment Report Period (Arm B Only)
Off Treatment
Off Treatment Report Period (Choose one)
Adverse event assessment
Were adverse events assessed during this report period (cycle)
I. BLOOD/BONE MARROW - LABS
CTC Adverse Event Term
CTC Adverse Event Grade (v4.0 - this cycle/report period - Report only Grade 3-5)
CTC Adverse Event Attribution Code (highest attributed to only protocol agent)
Action taken for this AE for Chemotherapy
Action taken for this AE for Bevacizumab
II. Non-Hematologic
CTC Adverse Event Term
CTC Adverse Event Grade (v4.0 - this cycle/report period - Report only Grade 3-5)
CTC Adverse Event Attribution Code (highest attributed to only protocol agent)
Action taken for this AE for Chemotherapy
Action taken for this AE for Bevacizumab
Blood/bone Marrow - Labs
CTC Adverse Event Term
CTC Adverse Event Grade (v4.0 - this cycle/report period - Report only Grade 3-5)
CTC Adverse Event Attribution Code (highest attributed to only protocol agent)
Action taken for this AE for Chemotherapy
Action taken for this AE for Bevacizumab
IV. GI Fistula
CTC Adverse Event Term
CTC Adverse Event Grade (v4.0 - this cycle/report period - Report only Grade 3-5)
CTC Adverse Event Attribution Code (highest attributed to only protocol agent)
Was this attributed to investigational protocol treatment
Blood/bone Marrow - Labs
CTC Adverse Event Term
CTC Adverse Event Grade (v4.0 - this cycle/report period - Report only Grade 3-5)
CTC Adverse Event Attribution Code (highest attributed to only protocol agent)
Was this attributed to investigational protocol treatment
VI. Hemorrhages
CTC Adverse Event Term
CTC Adverse Event Grade (v4.0 - this cycle/report period - Report only Grade 3-5)
CTC Adverse Event Attribution Code (highest attributed to only protocol agent)
Was this attributed to investigational protocol treatment
VII. Other Adverse Events (including Infections)
CTC Adverse Event Term
CTC Adverse Event Grade (v4.0 - this cycle/report period - Report only Grade 3-5)
CTC Adverse Event Attribution Code (highest attributed to only protocol agent)
Action taken for this AE for Chemotherapy
Action taken for this AE for Bevacizumab
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