Description:

FORM 5 - SYSTEMIC THERAPY & FOLLOW-UP REPORT NCT00090974 Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABF6F62D-7F89-673B-E034-0003BA12F5E7

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABF6F62D-7F89-673B-E034-0003BA12F5E7

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Versions (3) ▾
  1. 8/26/12
  2. 1/9/15
  3. 7/5/15
Uploaded on:

July 5, 2015

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Creative Commons BY-NC 3.0 Legacy
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FORM 5 - SYSTEMIC THERAPY & FOLLOW-UP REPORT NCT00090974

Details

To be completed on all patients at 6 and 12 months, then annually after randomization or until the patient discontinues all protocol treatment. To be submitted within 6 weeks of the date the patient was seen at the clinic. (After the patient has stopped receiving protocol treatment use Form 5S.)

Patient Information
Month Of Report
Month of report (circle one or enter # of months from randomization)
Physical Exam
Status of most recent clinical assessment
Systemic Therapy Report
Were there any dose modifications or additions/omissions to protocol treatment?
Has Aromatase Inhibitor been permanently discontinued?
Has Celecoxib/Placebo been permanently discontinued?
Adverse Events
Has the patient experienced a bone fracture since submission of last follow-up form?
Bone Fracture Site, Spinal (Check)
Bone Fracture Site, Wrist (Check)
Bone Fracture Site, Pelvis (Check)
Bone Fracture Site, Hip (Check)
Bone Fracture Site, Femur (Check)
Bone Fracture Site, Tibia (Check)
Bone Fracture Site, Ankle (Check)
Bone Fracture Site, Other (specify) (Check)
Has the patient had a new diagnosis of osteoporosis since submission of last follow-up form?
Has the patient suffered cardiovascular disease since submission of last follow-up form?
Cardiovascular Event, Myocardial infarction (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Cardiovascular Event, Stroke/transient ischemic attack (TIA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Cardiovascular Event, On-going angina (no surgical intervention) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Cardiovascular Event, Angina requiring percutaneous transluminal coronary angioplasty (PTCA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Cardiovascular Event, Thromboembolic event (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Cardiovascular Event, Other (specify) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Other Malignancies Or Myelodysplastic Syndrome
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
Hematology
Lab Unit of Measure (circle unit used)
Biochemistry
Investigations
Imaging site
Method of Evaluation
Toxicity Evaluation
Did the patient experience any new or continuing toxicities of protocol treatment since the last report?
CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
18 more items in the detailed view.
CTC Adverse Event Category (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
7 more items in the detailed view.
CTC Adverse Event Attribution Code
Treatment Given Since Last Report To Ncic Ctg
Is the patient receiving any non-protocol cancer therapy not previously reported?
Non-Protocol Raloxifene Therapy
Non-Protocol Bisphosphonate Therapy
Non-Protocol Lipid Lowering Therapy
Other Non-Protocol Therapy
Comments
Supporting Documentation
Investigator Signature
Ccrr Module For Form 5 - Systemic Therapy & Follow-up Report
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