Description:

ADVL0212: Reporting Period Worksheet FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia NCT00053963 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC15B1-1989-311F-E034-0003BA12F5E7

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC15B1-1989-311F-E034-0003BA12F5E7

Keywords:
Versions (6) ▾
  1. 8/26/12
  2. 1/8/15
  3. 1/9/15
  4. 1/9/15
  5. 3/22/15
  6. 3/22/15
Uploaded on:

March 22, 2015

DOI:
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License:
Creative Commons BY-NC 3.0 Legacy
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Recurring cancer children (ADVL0212 NCT00053963)

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  1. StudyEvent: ADVL0212: Reporting Period Worksheet
    1. No Instruction available.
Header
Patient characteristics
cm
Kg
Did patient have a bone marrow evaluation during this reporting interval? (1. Required field)
does patient have bone marrow involvement? (Reset)
Was patient's shortening fraction determined by echocardiogram?
Was patient's ejection fraction as determined by MUGA?
Is patient off protocol therapy at the end of this reporting period? (1. Required field)
reason off protocol therapy (Off Study is defined as lost to follow-up, death, entry onto another COG therapeutic protocol)
Was patient's disease status evaluated during this reporting interval? (1. Required field)
what was the patient's response? (1. If CR or PR, a request for submission of the response assessment form is generated if the form has not been filled out.)
mg
Were any of the infusions of Depsipeptide interrupted for any reason? (1. Required field)
Was there a deviation from protocol therapy? (1. Required field)
Did the patient receive radiation therapy during this reporting period? (1. Required field)
Was tumor tissue surgically obtained for biology studies (e.g. biopsy, resection, fine needle aspiration)? (1. Required field)
Did a second malignant neoplasm (SMN) occur during this Reporting Period? (If SMN is acute myelogenous leukemia or myelodysplastic syndrome MDS, submit the NCI secondary AML/MDS form, cytogenetics and pathology reports.)
Concomitant Medication
Did patient receive concomitant medications while on protocol therapy? (1. Required field)
Type (Type of drugs)
Patient status
Life status at end of this reporting period (1. Required field)
Was patient confirmed lost to follow up at the end of this reporting period? (1. Required field)
Was patient enrolled on another COG therapeutic study at the end of this reporting period? (1. Required field)
Was patient's consent withdrawn? (1. Required field)
Did patient relapse or experience disease progression during this reporting period? (1. Required field)
Adverse event
Category
Type
Code
Attribution (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
Adverse Drug Experience? (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
Dose Limiting Toxicity? (Reset)