ID

11080

Beschreibung

E2603 Treatment Form - Cycle 1 NCT00110019 Carboplatin and Paclitaxel With or Without Sorafenib in Treating Patients With Unresectable Stage III or Stage IV Melanoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FB6616F9-842C-441D-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FB6616F9-842C-441D-E034-0003BA3F9857

Stichworte

  1. 19.09.12 19.09.12 -
  2. 08.08.14 08.08.14 - Martin Dugas
  3. 08.01.15 08.01.15 - Martin Dugas
  4. 09.01.15 09.01.15 - Martin Dugas
  5. 18.06.15 18.06.15 -
Hochgeladen am

18. Juni 2015

DOI

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    E2603 Treatment Form - Cycle 1 NCT00110019

    INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle =3 weeks). Submit original to the ECOG Coordinating Center. Keep a copy for your files. Refer to forms packet for submission schedule

    Header
    Beschreibung

    Header

    ECOG Protocol Number
    Beschreibung

    Protocol Number ECOG

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Patient ID
    Beschreibung

    Patient ID ECOG

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    DCI Name
    Beschreibung

    Generic drug form

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C3242750
    NCI Thesaurus Property
    C19464
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus ObjectClass-2
    C25452
    Registration Step
    Beschreibung

    Registration Number

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    Patient demographics
    Beschreibung

    Patient demographics

    Patient Initials
    Beschreibung

    Patient Initials

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    ECOG Protocol Number
    Beschreibung

    Protocol Number ECOG

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    Participating Group Protocol Number
    Beschreibung

    Study Number Participating Group

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    ECOG Patient ID
    Beschreibung

    Patient ID ECOG

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    Institution/Affiliate
    Beschreibung

    Institution Name

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Participating Group Patient ID
    Beschreibung

    Trial subject ID Participating Group

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    On Treatment Report Period
    Beschreibung

    Cycle number

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25214
    NCI Thesaurus Property-2
    C25616
    NCI Thesaurus ObjectClass
    C15368
    Data amendment
    Beschreibung

    Data amendment

    Please mark an 'X' if data have been amended.
    Beschreibung

    Data amended

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Date data amended
    Beschreibung

    Data amended date

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property
    C25416
    NCI Thesaurus ValueDomain-2
    C25367
    Vital Status
    Beschreibung

    Vital Status

    Patient Vital Status
    Beschreibung

    Patient Status

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C3846084
    NCI Thesaurus ValueDomain
    C18003
    NCI Thesaurus ValueDomain-2
    C25688
    NCI Thesaurus Property
    C25717
    Date of last contact or death
    Beschreibung

    Date last contact

    Datentyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C0805839
    NCI Thesaurus Property
    C25461
    NCI Thesaurus Property-2
    C25551
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Primary Cause of Death (if applicable)
    Beschreibung

    Primary Cause of Death

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C28554
    NCI Thesaurus ValueDomain-2
    C25251
    Describe cause of death
    Beschreibung

    Cause of Death, specify

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1521902
    NCI Thesaurus Property
    C28554
    Cycle Information
    Beschreibung

    Cycle Information

    Cycle Start Date
    Beschreibung

    Chemotherapy Cycle Start Date

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1302181
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS CUI-2
    C3173309
    NCI Thesaurus Property
    C25379
    Cycle End Date
    Beschreibung

    Chemotherapy Cycle End Date

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1302181
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25379
    UMLS CUI-2
    C0806020
    ECOG Performance status (Day 1 of this cycle)
    Beschreibung

    PerformanceStatusScale

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C25361
    UMLS 2011AA ObjectClass
    C0597198
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Blood Pressure, Systolic (Note: Code hypotension/hypertension on adverse event form)
    Beschreibung

    Systolic blood pressure

    Datentyp

    float

    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0871470
    NCI Thesaurus Property
    C25214
    NCI Thesaurus ObjectClass
    C25298
    Blood Pressure, Diastolic (systolic/diastolic)
    Beschreibung

    Diastolic blood pressure

    Datentyp

    float

    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0428883
    NCI Thesaurus Property
    C25214
    NCI Thesaurus ObjectClass
    C25299
    Mark an 'X' if not done
    Beschreibung

    Laboratory Procedure Not Performed

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0022885
    NCI Thesaurus Property
    C25594
    UMLS CUI-2
    C0445106
    NCI Thesaurus Property-2
    C38000
    NCI Thesaurus ObjectClass
    C25294
    Weight (Day 1 of this cycle)
    Beschreibung

    Patient Weight

    Datentyp

    float

    Maßeinheiten
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    Therapy Administered
    Beschreibung

    Therapy Administered

    Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
    Beschreibung

    Dose Modification

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25256
    NCI Thesaurus Property
    C25572
    NCI Thesaurus ValueDomain-2
    C25572
    other, specify
    Beschreibung

    Dose Modification Reason, other

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Date agent administered
    Beschreibung

    Agent Administered Date

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0450442
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    UMLS CUI-3
    C0011008
    Agent Dose
    Beschreibung

    Medication Dose

    Datentyp

    float

    Alias
    NCI Thesaurus ValueDomain
    C25488
    UMLS CUI-1
    C3174092
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain-2
    C1708
    NCI Thesaurus Property
    C25382
    Dose Modification Reason
    Beschreibung

    Dose Modification Reason

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property
    C25572
    AUC
    Beschreibung

    AgentAreaUnderCurveValue

    Datentyp

    float

    Alias
    NCI Thesaurus Property
    C64774
    UMLS 2011AA Property
    C0376690
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Creatinine Clearance (Record value used to determine Carboplatin dose)
    Beschreibung

    Creatinine Clearance

    Datentyp

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0373595
    NCI Thesaurus Property-2
    C25747
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    Serum Creatinine (Value used to calculate Creatinine Clearance)
    Beschreibung

    PatientCreatinineSerumValue

    Datentyp

    float

    Maßeinheiten
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C13325
    UMLS 2011AA Property
    C0229671
    NCI Thesaurus Property-2
    C399
    UMLS 2011AA Property-2
    C0010294
    mg/dL
    Date obtained
    Beschreibung

    Datesampleobtained

    Datentyp

    text

    Agent Name: Paclitaxel
    Beschreibung

    Agent Name: Paclitaxel

    Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
    Beschreibung

    Dose Modification

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25256
    NCI Thesaurus Property
    C25572
    NCI Thesaurus ValueDomain-2
    C25572
    other, specify
    Beschreibung

    Dose Modification Reason, other

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Date agent administered
    Beschreibung

    Agent Administered Date

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0450442
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    UMLS CUI-3
    C0011008
    Agent Dose
    Beschreibung

    Medication Dose

    Datentyp

    float

    Alias
    NCI Thesaurus ValueDomain
    C25488
    UMLS CUI-1
    C3174092
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain-2
    C1708
    NCI Thesaurus Property
    C25382
    Dose Modification Reason
    Beschreibung

    Dose Modification Reason

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property
    C25572
    Agent Name: Bay 43-9006 Or Placebo
    Beschreibung

    Agent Name: Bay 43-9006 Or Placebo

    Number of pills per dose
    Beschreibung

    PillsQuantityDose

    Datentyp

    float

    Alias
    NCI Thesaurus ValueDomain
    C25488
    UMLS 2011AA ValueDomain
    C0178602
    NCI Thesaurus ObjectClass
    C25394
    UMLS 2011AA ObjectClass
    C0994475
    NCI Thesaurus Property
    C25256
    UMLS 2011AA Property
    C1265611
    Date of dose modifications
    Beschreibung

    DoseModificationDate

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25488
    UMLS 2011AA ObjectClass
    C0178602
    NCI Thesaurus Property
    C25572
    New dose
    Beschreibung

    PillsChangeAdministrationDose

    Datentyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C25394
    UMLS 2011AA ObjectClass
    C0994475
    NCI Thesaurus Property
    C25446
    UMLS 2011AA Property
    C0392747
    NCI Thesaurus Property-2
    C25409
    UMLS 2011AA Property-2
    C1533734
    NCI Thesaurus ValueDomain
    C25488
    UMLS 2011AA ValueDomain
    C0178602
    NCI Thesaurus ValueDomain-2
    C1708
    UMLS 2011AA ValueDomain-2
    C0450442
    Frequency
    Beschreibung

    Medication frequency

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-1
    C3476109
    NCI Thesaurus ValueDomain
    C25515
    NCI Thesaurus Property
    C25382
    Frequency
    Beschreibung

    Medication frequency

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-1
    C3476109
    NCI Thesaurus ValueDomain
    C25515
    NCI Thesaurus Property
    C25382
    Dose Modification Reason
    Beschreibung

    Dose Modification Reason

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property
    C25572
    Did the patient complete the Patient Pill Calendar this cycle
    Beschreibung

    Patient Diary complete

    Datentyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C3259162
    NCI Thesaurus Property
    C25250
    NCI Thesaurus ObjectClass
    C25394
    NCI Thesaurus Property-2
    C19459
    Total Number of Pills Taken (this cycle, based on the Patient Pill Calendar)
    Beschreibung

    PillsTakenTotalCount

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS 2011AA ValueDomain
    C0439810
    NCI Thesaurus ValueDomain-2
    C25463
    UMLS 2011AA ValueDomain-2
    C0750480
    NCI Thesaurus ObjectClass
    C25394
    UMLS 2011AA ObjectClass
    C0994475
    NCI Thesaurus Property
    C25701
    UMLS 2011AA Property
    C1883727
    Non-protocol Therapy
    Beschreibung

    Non-protocol Therapy

    Was any non-protocol therapy given during protocol treatment (not previously reported)
    Beschreibung

    Non-protocol therapy

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25590
    UMLS CUI-1
    C1518384
    NCI Thesaurus ObjectClass-2
    C16212
    UMLS CUI-2
    C0087111
    NCI Thesaurus Property
    C25320
    NCI Thesaurus Property-2
    C49236
    NCI Thesaurus Property-3
    C25456
    NCI Thesaurus Property-4
    C25382
    NCI Thesaurus ValueDomain
    C38148
    Related Forms
    Beschreibung

    Related Forms

    Comments
    Beschreibung

    Comments

    Comments
    Beschreibung

    Research Comments

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Investigator Signature
    Beschreibung

    Investigator Signature

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Investigator Signature Date
    Beschreibung

    Investigator Signature Date

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    UMLS CUI-2
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C17089

    Ähnliche Modelle

    INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle =3 weeks). Submit original to the ECOG Coordinating Center. Keep a copy for your files. Refer to forms packet for submission schedule

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Header
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Generic drug form
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C3242750 (UMLS CUI-1)
    C19464 (NCI Thesaurus Property)
    C25474 (NCI Thesaurus ObjectClass)
    C25452 (NCI Thesaurus ObjectClass-2)
    Registration Number
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    Item Group
    Patient demographics
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Study Number Participating Group
    Item
    Participating Group Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Item
    On Treatment Report Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25616 (NCI Thesaurus Property-2)
    C15368 (NCI Thesaurus ObjectClass)
    Code List
    On Treatment Report Period
    CL Item
    Cycle 1 (Cycle 1)
    Item Group
    Data amendment
    Data amended
    Item
    Please mark an 'X' if data have been amended.
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Data amended date
    Item
    Date data amended
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C0011008 (UMLS CUI-2)
    C25416 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item Group
    Vital Status
    Item
    Patient Vital Status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C3846084 (UMLS CUI-1)
    C18003 (NCI Thesaurus ValueDomain)
    C25688 (NCI Thesaurus ValueDomain-2)
    C25717 (NCI Thesaurus Property)
    Code List
    Patient Vital Status
    CL Item
    Alive (Alive)
    CL Item
    Dead (Dead)
    Date last contact
    Item
    Date of last contact or death
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0805839 (UMLS CUI-1)
    C25461 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item
    Primary Cause of Death (if applicable)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0007465 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C28554 (NCI Thesaurus Property)
    C25251 (NCI Thesaurus ValueDomain-2)
    Code List
    Primary Cause of Death (if applicable)
    CL Item
    Due To Protocol Treatment (Due to protocol treatment)
    CL Item
    Due To This Disease (Due to this disease)
    CL Item
    Due To Other Cause (Due to other cause)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Cause of Death, specify
    Item
    Describe cause of death
    text
    C25685 (NCI Thesaurus ValueDomain)
    C0007465 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1521902 (UMLS CUI-2)
    C28554 (NCI Thesaurus Property)
    Item Group
    Cycle Information
    Chemotherapy Cycle Start Date
    Item
    Cycle Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1302181 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus ValueDomain-2)
    C3173309 (UMLS CUI-2)
    C25379 (NCI Thesaurus Property)
    Chemotherapy Cycle End Date
    Item
    Cycle End Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1302181 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property)
    C0806020 (UMLS CUI-2)
    Item
    ECOG Performance status (Day 1 of this cycle)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C25361 (NCI Thesaurus ObjectClass)
    C0597198 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Code List
    ECOG Performance status (Day 1 of this cycle)
    CL Item
    Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (karnofsky 90 - 100) (ecog - 0 Asymptomatic) (0)
    CL Item
    Restricted In Physically Strenuous Activity But Ambulatory (k70 - 80) (ecog - 1 Symptomatic - Fully Ambulatory) (1)
    CL Item
    Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities (k 50 - 60) (ecog - 2 Symptomatic; In Bed , 50% Of The Day) (2)
    CL Item
    Capable Of Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (k 30 - 40) (ecog - 3 Symptomatic; In Bed > 50% Of The Day But Not Bedridden) (3)
    CL Item
    Completely Disabled (k10 - 20) (ecog - 4 Bedridden) (4)
    Systolic blood pressure
    Item
    Blood Pressure, Systolic (Note: Code hypotension/hypertension on adverse event form)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0871470 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25298 (NCI Thesaurus ObjectClass)
    Diastolic blood pressure
    Item
    Blood Pressure, Diastolic (systolic/diastolic)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0428883 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25299 (NCI Thesaurus ObjectClass)
    Laboratory Procedure Not Performed
    Item
    Mark an 'X' if not done
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0022885 (UMLS CUI-1)
    C25594 (NCI Thesaurus Property)
    C0445106 (UMLS CUI-2)
    C38000 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    Patient Weight
    Item
    Weight (Day 1 of this cycle)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Item Group
    Therapy Administered
    Item
    Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25256 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    C25572 (NCI Thesaurus ValueDomain-2)
    Code List
    Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes, planned)
    CL Item
    Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (yes, unplanned)
    CL Item
    Unknown (yes, both planned and unplanned)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Dose Modification Reason, other
    Item
    other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Agent Administered Date
    Item
    Date agent administered
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS CUI-1)
    C25367 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-3)
    Medication Dose
    Item
    Agent Dose
    float
    C25488 (NCI Thesaurus ValueDomain)
    C3174092 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain-2)
    C25382 (NCI Thesaurus Property)
    Item
    Dose Modification Reason
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Code List
    Dose Modification Reason
    CL Item
    Per Protocol (per protocol)
    CL Item
    Not Per Protocol (not per protocol)
    AgentAreaUnderCurveValue
    Item
    AUC
    float
    C64774 (NCI Thesaurus Property)
    C0376690 (UMLS 2011AA Property)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    Creatinine Clearance
    Item
    Creatinine Clearance (Record value used to determine Carboplatin dose)
    float
    C20200 (NCI Thesaurus Property)
    C0373595 (UMLS CUI-1)
    C25747 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    PatientCreatinineSerumValue
    Item
    Serum Creatinine (Value used to calculate Creatinine Clearance)
    float
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C13325 (NCI Thesaurus Property)
    C0229671 (UMLS 2011AA Property)
    C399 (NCI Thesaurus Property-2)
    C0010294 (UMLS 2011AA Property-2)
    Datesampleobtained
    Item
    Date obtained
    text
    Item Group
    Agent Name: Paclitaxel
    Item
    Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25256 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    C25572 (NCI Thesaurus ValueDomain-2)
    Code List
    Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes, planned)
    CL Item
    Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (yes, unplanned)
    CL Item
    Unknown (yes, both planned and unplanned)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Dose Modification Reason, other
    Item
    other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Agent Administered Date
    Item
    Date agent administered
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS CUI-1)
    C25367 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-3)
    Medication Dose
    Item
    Agent Dose
    float
    C25488 (NCI Thesaurus ValueDomain)
    C3174092 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain-2)
    C25382 (NCI Thesaurus Property)
    Item
    Dose Modification Reason
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Code List
    Dose Modification Reason
    CL Item
    Per Protocol (per protocol)
    CL Item
    Not Per Protocol (not per protocol)
    Item Group
    Agent Name: Bay 43-9006 Or Placebo
    PillsQuantityDose
    Item
    Number of pills per dose
    float
    C25488 (NCI Thesaurus ValueDomain)
    C0178602 (UMLS 2011AA ValueDomain)
    C25394 (NCI Thesaurus ObjectClass)
    C0994475 (UMLS 2011AA ObjectClass)
    C25256 (NCI Thesaurus Property)
    C1265611 (UMLS 2011AA Property)
    DoseModificationDate
    Item
    Date of dose modifications
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25488 (NCI Thesaurus ObjectClass)
    C0178602 (UMLS 2011AA ObjectClass)
    C25572 (NCI Thesaurus Property)
    PillsChangeAdministrationDose
    Item
    New dose
    float
    C25394 (NCI Thesaurus ObjectClass)
    C0994475 (UMLS 2011AA ObjectClass)
    C25446 (NCI Thesaurus Property)
    C0392747 (UMLS 2011AA Property)
    C25409 (NCI Thesaurus Property-2)
    C1533734 (UMLS 2011AA Property-2)
    C25488 (NCI Thesaurus ValueDomain)
    C0178602 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ValueDomain-2)
    C0450442 (UMLS 2011AA ValueDomain-2)
    Item
    Frequency
    text
    C1708 (NCI Thesaurus ObjectClass)
    C3476109 (UMLS CUI-1)
    C25515 (NCI Thesaurus ValueDomain)
    C25382 (NCI Thesaurus Property)
    Code List
    Frequency
    CL Item
    Once A Day (q.d.) (Once a day (Q.D.))
    CL Item
    Twice A Day (b.i.d) (twice a day (B.I.D))
    CL Item
    Dose Held (Dose held)
    Item
    Frequency
    text
    C1708 (NCI Thesaurus ObjectClass)
    C3476109 (UMLS CUI-1)
    C25515 (NCI Thesaurus ValueDomain)
    C25382 (NCI Thesaurus Property)
    Code List
    Frequency
    CL Item
    Once A Day (q.d.) (Once a day (Q.D.))
    CL Item
    Twice A Day (b.i.d) (twice a day (B.I.D))
    CL Item
    Dose Held (Dose held)
    Item
    Dose Modification Reason
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Code List
    Dose Modification Reason
    CL Item
    Per Protocol (per protocol)
    CL Item
    Not Per Protocol (not per protocol)
    Patient Diary complete
    Item
    Did the patient complete the Patient Pill Calendar this cycle
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C3259162 (UMLS CUI-1)
    C25250 (NCI Thesaurus Property)
    C25394 (NCI Thesaurus ObjectClass)
    C19459 (NCI Thesaurus Property-2)
    PillsTakenTotalCount
    Item
    Total Number of Pills Taken (this cycle, based on the Patient Pill Calendar)
    text
    C25304 (NCI Thesaurus ValueDomain)
    C0439810 (UMLS 2011AA ValueDomain)
    C25463 (NCI Thesaurus ValueDomain-2)
    C0750480 (UMLS 2011AA ValueDomain-2)
    C25394 (NCI Thesaurus ObjectClass)
    C0994475 (UMLS 2011AA ObjectClass)
    C25701 (NCI Thesaurus Property)
    C1883727 (UMLS 2011AA Property)
    Item Group
    Non-protocol Therapy
    Non-protocol therapy
    Item
    Was any non-protocol therapy given during protocol treatment (not previously reported)
    boolean
    C25590 (NCI Thesaurus ObjectClass)
    C1518384 (UMLS CUI-1)
    C16212 (NCI Thesaurus ObjectClass-2)
    C0087111 (UMLS CUI-2)
    C25320 (NCI Thesaurus Property)
    C49236 (NCI Thesaurus Property-2)
    C25456 (NCI Thesaurus Property-3)
    C25382 (NCI Thesaurus Property-4)
    C38148 (NCI Thesaurus ValueDomain)
    Item Group
    Related Forms
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Investigator Signature
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    Investigator Signature Date
    Item
    Investigator Signature Date
    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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