ID

7393

Beschreibung

Concomitant Medications Form (Form 24-CCM) Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG-2402 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0EA006A-EBFE-628F-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0EA006A-EBFE-628F-E034-0003BA12F5E7

Stichworte

Versionen (2)
  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Breast Cancer NCT00659373 Treatment - Concomitant Medications Form (Form 24-CCM) - 2072606v3.0

Englisch

CONCOMITANT MEDICATIONS FORM (Form 24-CCM) Instructions: This form is to be completed: -> Prior to starting any protocol therapy (Tamoxifen, Exemestane, OFS), and -> On the same schedule as the Follow-Up Form (24-E) (every 3 months in Year 1, every six months in Years 2-5) (during Tamoxifen, Exemestane, OFS), and -> At 6 and 12 months after the last dose of all protocol therapy (Tamoxifen, Exemestane, OFS). -> No CCM Forms are required after first relapse/recurrence. Use minus one (-1) to indicate that an answer is unknown, unobtainable, or not done.

1 Formulare  
Ccrr Module For Concomitant Medications Form (form 24-ccm)
Beschreibung

Ccrr Module For Concomitant Medications Form (form 24-ccm)

Patient ID Number (Study No.)
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Patient Initials (f m fl sl)
Beschreibung

PatientInitials

Datentyp

text

Patient's Date of Birth (day)
Beschreibung

PatientBirthDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Participating Center/Affiliate
Beschreibung

MainMemberInstitution/Affiliate

Datentyp

text

Center Code (Ver.#1)
Beschreibung

CoordinatingGroupCode

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Did patient receive any of the concomitant medications listed in the Concomitant Medication Code box below
Beschreibung

Didpatientreceiveanyoftheconcomitantmedicationslistedonthisformoranyotherrelevantmedications?

Datentyp

boolean

Concomitant Medication
Beschreibung

ConcomitantBreastMedicationReceivedType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus ObjectClass-3
C25730
UMLS 2011AA ObjectClass-3
C0521115
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other relevant drug, specify
Beschreibung

ConcomitantMedicationUseSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Agent Name
Beschreibung

Agent

Datentyp

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Agent Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Agent End Date
Beschreibung

Medication End Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Primary Reason
Beschreibung

ConcomitantBreastMedicationReceivedReason

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus ObjectClass-3
C25730
UMLS 2011AA ObjectClass-3
C0521115
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Specify other reason
Beschreibung

Concomitant Medication Use Indication

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS CUI-1
C2826696
NCI Thesaurus ObjectClass-2
C25730
NCI Thesaurus Property
C25382
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25638
Route of Administration
Beschreibung

Drug administration method

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0449311
NCI Metathesaurus ObjectClass
CL111054
NCI Thesaurus Property
C25409
Specify other route
Beschreibung

MedicationAdministrationRouteSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25409
UMLS 2011AA ObjectClass-2
C1533734
NCI Thesaurus Property
C25169
UMLS 2011AA Property
C0449444
Continuing
Beschreibung

ConcomitantBreastMedicationReceivedText

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus ObjectClass-3
C25730
UMLS 2011AA ObjectClass-3
C0521115
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Investigator/Designee Signature
Beschreibung

InvestigatorSignature

Datentyp

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date (day month year)
Beschreibung

InvestigatorSignatureDate

Datentyp

date

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Ähnliche Modelle

CONCOMITANT MEDICATIONS FORM (Form 24-CCM) Instructions: This form is to be completed: -> Prior to starting any protocol therapy (Tamoxifen, Exemestane, OFS), and -> On the same schedule as the Follow-Up Form (24-E) (every 3 months in Year 1, every six months in Years 2-5) (during Tamoxifen, Exemestane, OFS), and -> At 6 and 12 months after the last dose of all protocol therapy (Tamoxifen, Exemestane, OFS). -> No CCM Forms are required after first relapse/recurrence. Use minus one (-1) to indicate that an answer is unknown, unobtainable, or not done.

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Ccrr Module For Concomitant Medications Form (form 24-ccm)
PatientStudyID,CoordinatingGroup
Item
Patient ID Number (Study No.)
text
PatientInitials
Item
Patient Initials (f m fl sl)
text
PatientBirthDate
Item
Patient's Date of Birth (day)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
MainMemberInstitution/Affiliate
Item
Participating Center/Affiliate
text
CoordinatingGroupCode
Item
Center Code (Ver.#1)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
Didpatientreceiveanyoftheconcomitantmedicationslistedonthisformoranyotherrelevantmedications?
Item
Did patient receive any of the concomitant medications listed in the Concomitant Medication Code box below
boolean
Item
Concomitant Medication
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25730 (NCI Thesaurus ObjectClass-3)
C0521115 (UMLS 2011AA ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Concomitant Medication
CL Item
Anastrozole (Anastrozole)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Androgens (Androgens)
CL Item
Anti-depressants (Anti-depressants)
CL Item
Bisphosphonates (Bisphosphonates)
CL Item
Calcitonin (Calcitonin)
C2281 (NCI Thesaurus)
C0770558 (UMLS 2011AA)
CL Item
Calcium Supplements (Calcium supplements)
CL Item
Estrogen (Estrogen)
C2293 (NCI Thesaurus)
C0014939 (UMLS 2011AA)
CL Item
Letrozole (Letrozole)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Other Lipid / Cholesterol-lowering Drug (Other lipid / cholesterol-lowering drug)
CL Item
Other Relevant Drug, Specify (Other relevant drug, specify)
CL Item
Progesterone (Progesterone)
C2297 (NCI Thesaurus)
C0033308 (UMLS 2011AA)
CL Item
Raloxifene (Raloxifene)
C1518 (NCI Thesaurus)
C0244404 (UMLS 2011AA)
CL Item
Regular Use Of Sleeping Tablets (Regular use of sleeping tablets)
CL Item
Statins (Statins)
CL Item
Toremifene (Toremifene)
C1256 (NCI Thesaurus)
C0076836 (UMLS 2011AA)
CL Item
Trastuzumab (Trastuzumab)
C1647 (NCI Thesaurus)
C0338204 (UMLS 2011AA)
CL Item
Vitamin D3 (Vitamin D3)
ConcomitantMedicationUseSpecify
Item
Other relevant drug, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Medication Start Date
Item
Agent Start Date
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Medication End Date
Item
Agent End Date
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Item
Primary Reason
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25730 (NCI Thesaurus ObjectClass-3)
C0521115 (UMLS 2011AA ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.3
Code List
Primary Reason
CL Item
Anxiety (Anxiety)
CL Item
Birth Control (Birth control)
C0005601 (NCI Metathesaurus)
CL Item
Cardiac Ischemia/infarction (Cardiac ischemia/infarction)
CL Item
Cerebrovascular Ischemia (cns) (Cerebrovascular ischemia (CNS))
CL Item
Depression (Depression)
C2982 (NCI Thesaurus)
C0011570 (UMLS 2011AA)
CL Item
Elevated Lipids (Elevated lipids)
CL Item
Fatigue (Fatigue)
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Hormone Replacement Therapy (Hormone replacement therapy)
C15599 (NCI Thesaurus)
C0282402 (UMLS 2011AA)
CL Item
Hot Flushes/night Sweats (Hot flushes/night sweats)
CL Item
Hypertension (Hypertension)
C3117 (NCI Thesaurus)
C0020538 (UMLS 2011AA)
CL Item
Insomnia (Insomnia)
C28286 (NCI Thesaurus)
C0917801 (UMLS 2011AA)
CL Item
Musculoskeletal Pain (Musculoskeletal pain)
CL Item
Osteoporosis/bone Mineral Density (bmd) (Osteoporosis/bone mineral density (BMD))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Pain (Other pain)
CL Item
Prevention Of Breast Cancer Relapse (Prevention of breast cancer relapse)
CL Item
Libido Decreased (Reduced libido)
C0011124 (NCI Metathesaurus)
Concomitant Medication Use Indication
Item
Specify other reason
text
C459 (NCI Thesaurus ObjectClass)
C2826696 (UMLS CUI-1)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C25638 (NCI Thesaurus ValueDomain-2)
Item
Route of Administration
text
C25284 (NCI Thesaurus ValueDomain)
C0449311 (UMLS CUI-1)
CL111054 (NCI Metathesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
CL.4
Code List
Route of Administration
CL Item
Injection/transdermal (injection/implant)
CL Item
Nasal Route Of Administration (nasal)
C38284 (NCI Thesaurus)
C1522019 (UMLS 2011AA)
CL Item
Ocular (Ocular)
C0521414 (NCI Metathesaurus)
CL Item
Oral Administration Of Drug (oral)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Ndc Transdermal - 358 (transdermal/topical)
CL Item
Vaginal Route Of Administration (vaginal)
C38313 (NCI Thesaurus)
C1522570 (UMLS 2011AA)
MedicationAdministrationRouteSpecify
Item
Specify other route
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus ObjectClass-2)
C1533734 (UMLS 2011AA ObjectClass-2)
C25169 (NCI Thesaurus Property)
C0449444 (UMLS 2011AA Property)
ConcomitantBreastMedicationReceivedText
Item
Continuing
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25730 (NCI Thesaurus ObjectClass-3)
C0521115 (UMLS 2011AA ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
InvestigatorSignature
Item
Investigator/Designee Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date (day month year)
date
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