Description:

NCIC MA.32 Short Follow-Up 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=81DD7330-A8C4-A3E4-E040-BB89AD43612E

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81DD7330-A8C4-A3E4-E040-BB89AD43612E

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Versions (3) ▾
  1. 12/15/14
  2. 1/9/15
  3. 9/17/21
Uploaded on:

September 17, 2021

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License:
Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01101438 Follow-Up - NCIC MA.32 Short Follow-Up Report Form - 3026031v1.0

Aim - The purpose of the Short Follow-Up Report is to collect follow-up information on all patients who have permanently discontinued protocol treatment. Follow-Up visits after end of protocol treatment must occur annually. Each Short Follow-Up Report Folder must contain information for the time interval between the most recent protocol-mandated clinic visit and the current protocol-mandated clinic visit. Completion A Short Follow-Up Report Folder must be completed within 6 weeks after each Follow-Up visit Timing of Investigations - The timing of protocol-required investigations for the interval covered by the Short Follow-Up Report is as follows: ¿ Physical exam - at each clinic visit ¿ Radiology - mammogram (annually from baseline mammogram) of any remaining breast tissue is required until the time of distant recurrence / progression or an incurable non-breast primary malignancy ¿ Adverse Events (AEs) - patients must be evaluated ONLY for adverse events that are related to protocol therapy at each clinic visit (except for cardiovascular adverse events associated with hospitalizations ¿ these need to be reported regardless of attribution).

Physical Exam
Off Treatment Report Period
Visit Type
Kg
kg/m2
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
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
1000/uL
mm3
Biochemistry
Was sample obtained
mg/dL
mg/dL
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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