Description:

CALGB: 80405 SUPPLEMENTAL ADVERSE EVENT FORM NCT00265850 Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F39D4556-5D0B-6221-E034-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F39D4556-5D0B-6221-E034-0003BA3F9857

Keywords:
Versions (3) ▾
  1. 8/27/12
  2. 1/8/15
  3. 6/8/15
Uploaded on:

June 8, 2015

DOI:
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License:
Creative Commons BY-NC 3.0 Legacy
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CALGB: 80405 SUPPLEMENTAL ADVERSE EVENT FORM NCT00265850

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

Header
Are data amended
Patient demographics
Assessment of medication
Medications received during this reporting period (Mark one with an X)
Which of the following arterial thrombotic events (ATEs) occurred during this reporting period? (Mark one with an X)
Treatment for ATE (Mark one with an X)
Outcome of ATE (Mark one with an X)
Which of the following venous thrombotic events (VTEs) occurred during this reporting period? (Mark one with an X)
Was the patient receiving anticoagulants prior to the VTEt?
Were anticoagulants used to treate the VTE?
Treatment for VTE (Mark one with an X)
Outcome of VTE (Mark one with an X)
Did the patient experience an infusion reaction to cetuximab during the reporting period? (refer to CTCAE v. 3 Cytokine release syndrome/acute infusion reaction)
Were steroids given pre-infusion (including as an antiemetic?)
Was blood drawn for infusion reaction biomarkers?
Treatment (Mark one with an X)
Outcome (Mark one with an X)
Was the patient retreated with cetuximab after the reaction?
If Yes, did the patient experience an acute infusion reaction upon retreatment?

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