OVARIAN FUNCTION SUPPRESSION FORM (Form 24-OFS) Instructions: This form is to be completed and submitted for patients randomized to Ovarian Function Suppression (OFS) and for patients who were not randomized to receive OFS but received it. Submit this form at each follow-up period (every three months in Year 1, every six months in Years 2-6) until the completion of OFS. (If patient receives surgical oophorectomy, submit this form only once. If patient receives bilateral ovarian radiation therapy, submit until ovarian function suppression is confirmed.) Mark your selection with an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable, or not done.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Ccrr Module For Ovarian Function Suppression Form-revised (form 24-ofs)
PatientStudyID,CoordinatingGroup
Item
Patient ID No.
text
Patient Initials
Item
Patient Initials (f m fl sl)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Birth Date
Item
Patient's Date of Birth (day)
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
ParticipatingCenter/Affiliate
Item
Participating Center/Affiliate
text
ParticipatingGroupCode
Item
Center Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
Item
Did patient receive Ovarian Function Suppression (OFS) during this follow-up period
text
CL.1
Code List
Did patient receive Ovarian Function Suppression (OFS) during this follow-up period
CL Item
No, Will Never Start. (No, will never start.)
CL Item
No, Will Start Later, Submit With Next Follow-up Form (No, will start later)
CL Item
Yes, Continuing (Yes, continuing)
CL Item
Yes, But Stopped Early. (Yes, but stopped early)
CL Item
Yes, Completed Per Protocol (Yes, completed per protocol)
Item
If OFS will start later, reason
text
CL.2
Code List
If OFS will start later, reason
CL Item
Patient Refusal (Patient refusal)
CL Item
Adverse Event(s), Specify (Adverse event(s), specify)
CL Item
Medical Decision, Specify (Medical decision, specify)
CL Item
Error (Error)
C0743559 (NCI Metathesaurus)
CL Item
Other, Specify (Other, specify)
Adverseevent,specify
Item
Adverse event, specify
text
Other,specify(OFSlater)
Item
Other, specify (OFS later)
text
Adverseevent,specify
Item
Adverse event, specify
text
Item
If stopped early or never started, reason (select one and sign & date at the bottom of this form - DataFax only page 1.)
text
CL.3
Code List
If stopped early or never started, reason (select one and sign & date at the bottom of this form - DataFax only page 1.)
CL Item
Patient Refusal (Patient refusal)
CL Item
Adverse Event(s), Specify (Adverse event(s), specify)
CL Item
Medical Decision, Specify (Medical decision, specify)
CL Item
Recurrence (Recurrence)
C3352 (NCI Thesaurus)
C0034897 (UMLS 2011AA)
CL Item
Death On Study (Death on study)
CL Item
Error (Error)
C0743559 (NCI Metathesaurus)
CL Item
Other, Specify (Other, specify)
CL Item
Gnrh Analogue Failed To Suppress Ovarian Function (GnRH analogue failed to suppress ovarian function)
Medicaldecision,specify
Item
Medical decision, specify
text
Medicaldecision,specify
Item
Medical decision, specify
text
Other,
Item
Other, specify
text
Item
Which method(s) of OFS did patient receive?
text
CL.4
Code List
Which method(s) of OFS did patient receive?
CL Item
Gnrh Analogue (GnRH analogue)
CL Item
Surgical Oophorectomy (Surgical oophorectomy)
CL Item
Bilateral ovarian radiation therapy (Bilateral ovarian radiation therapy)
Item Group
Gnrh Analogue
Item
Agent Name
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2022 (NCI Thesaurus Property-2)
C1518041 (UMLS 2011AA Property-2)
CL.5
Code List
Agent Name
CL Item
Decapeptyl (Decapeptyl)
CL Item
Goserelin (Goserelin)
C1374 (NCI Thesaurus)
C0120107 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Trelstar Depot (Trelstar Depot)
CL Item
Triptorelin (Triptorelin)
C1267 (NCI Thesaurus)
C0077275 (UMLS 2011AA)
HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property-2)
C1518041 (UMLS 2011AA Property-2)
Item
Route of Administration
text
C25284 (NCI Thesaurus ValueDomain)
C0449311 (UMLS CUI-1)
CL111054 (NCI Metathesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
CL.6
Code List
Route of Administration
CL Item
Intramuscular (Intramuscular)
C27974 (NCI Thesaurus)
C0442117 (UMLS 2011AA)
CL Item
Subcutaneous (Subcutaneous)
C13353 (NCI Thesaurus)
C0443315 (UMLS 2011AA)
DateAgentAdministered
Item
Date Agent Administered
text
Administeredby(initials)
Item
Administered by (initials)
text
BatchNumber
Item
Batch Number
text
Item
Compliance Code
text
CL.7
Code List
Compliance Code
CL Item
Taken As Per Protocol (Taken as per protocol)
CL Item
Delayed For At Least One Month (Delayed for at least one month)
CL Item
Not Taken At All (Not taken at all)
CL Item
Other, Specify (Other, specify)
Other,specify(compliancecode)
Item
Other, specify (compliance code)
text
Item
Reason not taken code
text
CL.8
Code List
Reason not taken code
CL Item
Patient Refusal (Patient refusal)
CL Item
Recurrence/relapse (Recurrence/relapse)
CL Item
Adverse Event, Specify (Adverse event, specify)
CL Item
Other, Specify (Other, specify)
Adverseevent,specify
Item
Adverse event, specify
text
Other,specify(reasonnottaken)
Item
Other, specify (reason not taken)
text
Isthisthefinaltreatment?
Item
Is this the final treatment
boolean
Item Group
Surgical Oophorectomy
Dateofsurgicaloophorectomy
Item
Date of surgical oophorectomy (day month year)
text
BilateralOophorectomyPerformedIBCSGInd-2
Item
Was the oophorectomy bilateral
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C13332 (NCI Thesaurus ObjectClass)
C0238767 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15291 (NCI Thesaurus ObjectClass-2)
C0029936 (UMLS 2011AA ObjectClass-2)
BilateralOophorectomyPerformedIBCSGSpecify
Item
Reason
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C13332 (NCI Thesaurus ObjectClass)
C0238767 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15291 (NCI Thesaurus ObjectClass-2)
C0029936 (UMLS 2011AA ObjectClass-2)
Item
This oophorectomy is (Report oophorectomy for reasons other than protocol-related ovarian function suppression on Forms 24-E and 24-GYN.)
text
CL.11
Code List
This oophorectomy is (Report oophorectomy for reasons other than protocol-related ovarian function suppression on Forms 24-E and 24-GYN.)
CL Item
Initial Attempt At Ovarian Function Suppression (Initial attempt at ovarian function suppression)
CL Item
Surgical Oophorectomy After Receiving Gnrh Analogue (Surgical oophorectomy after receiving GnRH analogue)
CL Item
Surgical Oophorectomy After Receiving Failed Ovarian Radiation (Surgical oophorectomy after receiving failed ovarian radiation)
Item
Reason
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C12404 (NCI Thesaurus ObjectClass)
C0029939 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)
CL.12
Code List
Reason
CL Item
Gnrh Failed (GnRH failed)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item Group
Bilateral Ovarian Radiation Therapy
RTBeginDate
Item
Radiation Therapy Start Date (day month year)
date
RTEndDate
Item
Radiation Therapy End Date (day month year)
date
RTTotalDose
Item
Total Dose of Radiation Therapy (cGy)
float
Item Group
Confirmation Of Biochemical Evidence Of Cessation Of Ovarian Function After Ovarian Radiotherapy Is Completed.
Estradiolpmol/L
Item
Estradiol pmol/L
text
Institutionallowerlimitforpremenopausal
Item
Institutional lower limit for premenopausal (pmol/L)
text
Institutionalupperlimitforpostmenopausal
Item
Institutional upper limit for postmenopausal (pmol/L)
text
Dateblooddrawnforthisestradiollevel
Item
Date blood drawn for this estradiol level (day month year)
text
Item
This radiation therapy is
text
CL.13
Code List
This radiation therapy is
CL Item
Initial Attempt At Ovarian Function Suppression (Initial attempt at ovarian function suppression)
CL Item
Bilateral Ovarian Radiation Therapy After Receiving Gnrh Analogue (Bilateral ovarian radiation therapy after receiving GnRH analogue)
Item
Reason
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
CL.14
Code List
Reason
CL Item
Gnrh Failed (GnRH failed)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
RTTreatmentIBCSGSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
Investigator Signature
Item
Investigator Signature (Designee)
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Date (day month year)
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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