Description:

NCIC MA.32 Treatment Report Form A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=80FC65BF-C111-5459-E040-BB89AD430BEC

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=80FC65BF-C111-5459-E040-BB89AD430BEC

Keywords:
Versions (5) ▾
  1. 8/8/14
  2. 1/8/15
  3. 1/9/15
  4. 8/7/15
  5. 9/20/21
Uploaded on:

September 20, 2021

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License:
Creative Commons BY-NC 3.0 Legacy
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Treatment Form Breast Cancer Early Stage NCIC MA.32 NCT01101438

The purpose of the "Treatment Report" is to document drug administration, adverse events and response for one reporting period. For this study a reporting period is defined as one cycle (i.e. 1 cycle = 3 weeks or 21 days). Cycle length will be increased in cases where the start of the next cycle of treatment is delayed and will be decreased if the patient goes off protocol treatment before the end of the cycle. The "Treatment Report" should be completed within 2 weeks of the end of each reporting period.

Patient Information
Timing Of Report
On Treatment Reporting Period
Physical Exam
kg
kg/m2
cm
cm
mmHg
mmHg
Disease Status
Status of Most Recent Clinical Assessment
In Situ Disease Follow-up
Since the last report has there been a biopsy proven diagnosis of DCIS
Tumor Laterality
Kit Return - Question
Have any treatment kits been returned this reporting period
Kit Return
Kit Dispension - Question
Have any treatment kits been dispensed this reporting period
Kit Dispensation
Metformin/placebo Administration - Ramp-up
Metformin/placebo Administration
Has subject taken protocol medication every day
Dose Modification Reason (If no, please enter the reasons for dose modifications in the table below:)
Was this dose modification or addition/omission as per protocol guidelines
Radiology Investigations - Question
Was a mammogram performed
Mammogram laterality
Specify side
Was imaging done to assess for recurrence (other than mammogram)
Radiology Investigations
Type of imaging
Result
Hematology
Was sample obtained
g/dL
g/dL
g/dL
1000/uL
1000/ul
1000/ul
/ul
/ul
/ul
1000/uL
1000/ul
1000/ul
fl
fl
fl
Biochemistry
Was sample obtained
U/L
U/L
U/L
U/L
U/L
U/L
U/L
U/L
U/L
mg/dL
mg/dL
mg/dL
mg/dL
mg/dL
mg/dL
pg/ml
pg/ml
pg/ml
mg/dL
mg/dL
mg/dL
Serious Adverse Event - Question
Did the patient experience a Serious Adverse Event, as defined in protocol section 11, during this reporting period
Adverse Events On Treatment - Question
Were any additional adverse events experienced by the patient
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
Has there been a new diagnosis of diabetes since the last report
Adverse Events
Would you like to carry forward the adverse events (indicated as continuing) from the previous reporting period
CTCAE Term
AE Ongoing
Seriousness Attributed to Adverse Event
Attribution
Cardiovascular Morbidity - Question
Has there been a hospitalization for a cardiovascular event since the last report
Cardiovascular Mobidity
Problem, cardiovascular
Cancer Treatment Since Last Report ¿ Question
Has patient received any new treatment for breast cancer since the last report
Cancer Treatment Since Last Report
Non-Protocol Therapy Type
Major Medical Problems
Quality Of Life Questionnaire
Was this subject one of the sub-set of subjects who completed questionnaires at baseline
Questionnaire
Done
Reason questionnaire was not completed
Comments
Contact Information

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