ID

37937

Descripción

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Palabras clave

Versiones (1)
  1. 1/9/19 1/9/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

1 de septiembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

    Inglés

    Course 3 (Day 15 ) - Vital Signs; Hematology; Administration of Study Medications

    1 formularios  
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Center Number
    Descripción

    Center Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Patient Number
    Descripción

    Patient Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1709561
    Patient ID
    Descripción

    Patient ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Descripción

    Date of Visit

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Visit not done
    Descripción

    Visit not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1272696
    Day 15 Vital Signs
    Descripción

    Day 15 Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Systolic Blood Pressure
    Descripción

    Sitting after 5 mins.

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Descripción

    Sitting after 5 mins.

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Pulse
    Descripción

    Sitting after 5 mins.

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Temperature
    Descripción

    Temperature

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005903
    Temperature Unit
    Descripción

    Temperature Unit

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C1519795
    Hematology
    Descripción

    Hematology

    Alias
    UMLS CUI-1
    C0474523
    Hematology - Sample Date
    Descripción

    Hematology - Sample Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0018941
    Haematology - Laboratory Name
    Descripción

    Haematology - Laboratory Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3258037
    UMLS CUI [1,2]
    C0018941
    Hematology
    Descripción

    Hematology

    Alias
    UMLS CUI-1
    C0474523
    Hematology Test
    Descripción

    Hematology Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Hematology - No Result
    Descripción

    Hematology - No Result

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C1274040
    Hematology - Value
    Descripción

    Hematology - Value

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0474523
    Hematology - Value out of range and NOT clinically significant
    Descripción

    Hematology - Value out of range and NOT clinically significant

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0438215
    UMLS CUI [1,3]
    C2826293
    Hematology - Value out of range and clinically significant
    Descripción

    Hematology - Value out of range and clinically significant

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0438215
    UMLS CUI [1,3]
    C2826293
    Day 15 Administration of Study Medications
    Descripción

    Day 15 Administration of Study Medications

    Alias
    UMLS CUI-1
    C3469597
    UMLS CUI-2
    C0304229
    Were the study medications administered at Day 15?
    Descripción

    Were the study medications administered at Day 15?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    If study medication was not administered at Day 15, mark reason(s) why
    Descripción

    If study medication was not administered at Day 15, mark reason(s) why

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [2]
    C2826287
    If other reason for medication not administered, specify
    Descripción

    If other reason for medication not administered, specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [2,1]
    C2826287
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Topotecan Administration
    Descripción

    Topotecan Administration

    Alias
    UMLS CUI-1
    C3469597
    UMLS CUI-2
    C0146224
    Was the topotecan dose reduced?
    Descripción

    Was the topotecan dose reduced?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1707814
    If topotecan dose was reduced, mark reason(s) dose was reduced
    Descripción

    If topotecan dose was reduced, mark reason(s) dose was reduced

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C3146298
    If other reason topotecan dose was reduced, specify
    Descripción

    If other reason topotecan dose was reduced, specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C3146298
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Topotecan Dose Modification
    Descripción

    Topotecan Dose Modification

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1707811
    UMLS CUI [1,2]
    C0146224
    If other topotecan dose reduction, specify
    Descripción

    If other topotecan dose reduction, specify

    Tipo de datos

    integer

    Unidades de medida
    • %
    Alias
    UMLS CUI [1,1]
    C1707814
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    %
    Topotecan scheduled dose
    Descripción

    Topotecan scheduled dose

    Tipo de datos

    float

    Unidades de medida
    • mg/m2
    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C3174092
    UMLS CUI [1,3]
    C0205539
    mg/m2
    Total mg to be given (Topotecan)
    Descripción

    Total mg to be given (Topotecan)

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [2]
    C0146224
    mg
    Date Administered (Topotecan)
    Descripción

    Date Administered (Topotecan)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2]
    C0146224
    Start Time (Topotecan)
    Descripción

    Start Time (Topotecan)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C1301880
    UMLS CUI [2]
    C0146224
    Stop Time (Topotecan)
    Descripción

    Stop Time (Topotecan)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C1522314
    UMLS CUI [2]
    C0146224
    Was complete dose given? (Topotecan)
    Descripción

    Was complete dose given? (Topotecan)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [2]
    C0146224
    If complete dose Topotecan was not given, provide actual mg given:
    Descripción

    If complete dose Topotecan was not given, provide actual mg given:

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [2]
    C0146224
    mg
    Gemcitabine Administration
    Descripción

    Gemcitabine Administration

    Alias
    UMLS CUI-1
    C3469597
    UMLS CUI-2
    C0045093
    Was the gemcitabine dose reduced?
    Descripción

    Was the gemcitabine dose reduced?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0045093
    UMLS CUI [1,2]
    C1707814
    If gemcitabine dose was reduced, mark reason(s) dose was reduced
    Descripción

    If gemcitabine dose was reduced, mark reason(s) dose was reduced

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0045093
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C3146298
    If other reason gemcitabine dose was reduced, specify
    Descripción

    If other reason gemcitabine dose was reduced, specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0045093
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C3146298
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Gemcitabine Dose Modification
    Descripción

    Gemcitabine Dose Modification

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1707811
    UMLS CUI [1,2]
    C0045093
    If other gemcitabine dose reduction, specify
    Descripción

    If other gemcitabine dose reduction, specify

    Tipo de datos

    integer

    Unidades de medida
    • %
    Alias
    UMLS CUI [1,1]
    C1707814
    UMLS CUI [1,2]
    C0045093
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    %
    Gemcitabine scheduled dose
    Descripción

    Gemcitabine scheduled dose

    Tipo de datos

    float

    Unidades de medida
    • mg/m2
    Alias
    UMLS CUI [1,1]
    C0045093
    UMLS CUI [1,2]
    C3174092
    UMLS CUI [1,3]
    C0205539
    mg/m2
    Total mg to be given (Gemicitabine)
    Descripción

    Total mg to be given (Gemicitabine)

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [1,3]
    C0045093
    mg
    Date Administered (Gemicitabine)
    Descripción

    Date Administered (Gemicitabine)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0045093
    Start Time (Gemicitabine)
    Descripción

    Start Time (Gemicitabine)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0045093
    Stop Time (Gemicitabine)
    Descripción

    Stop Time (Gemicitabine)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0045093
    Was complete dose given? (Gemicitabine)
    Descripción

    Was complete dose given? (Gemicitabine)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [1,3]
    C0045093
    If complete dose Gemcitabine was not given, provide actual mg given:
    Descripción

    If complete dose Gemcitabine was not given, provide actual mg given:

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [1,3]
    C0045093
    mg
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    Similar models

    Course 3 (Day 15 ) - Vital Signs; Hematology; Administration of Study Medications

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Center Number
    Item
    Center Number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C1709561 (UMLS CUI [1])
    Patient ID
    Item
    Patient ID
    text
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit not done
    integer
    C0545082 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Visit not done
    Code List
    Visit not done
    CL Item
    Visit Not Done (1)
    Item Group
    Day 15 Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    Temperature Unit
    integer
    C0005903 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Temperature Unit
    Code List
    Temperature Unit
    CL Item
    °C (1)
    CL Item
    °F (2)
    Item Group
    Hematology
    C0474523 (UMLS CUI-1)
    Hematology - Sample Date
    Item
    Hematology - Sample Date
    date
    C1302413 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    Haematology - Laboratory Name
    Item
    Haematology - Laboratory Name
    text
    C3258037 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    Item Group
    Hematology
    C0474523 (UMLS CUI-1)
    Item
    Hematology Test
    integer
    C0018941 (UMLS CUI [1])
    Hematology Test
    Code List
    Hematology Test
    CL Item
    Hemoglobin  (1)
    CL Item
    Hematocrit  (2)
    CL Item
    RBC  (3)
    CL Item
    WBC  (4)
    CL Item
    Neutrophils  (5)
    CL Item
    Bands  (6)
    CL Item
    Lymphocytes  (7)
    CL Item
    Monocytes  (8)
    CL Item
    Eosinophils  (9)
    CL Item
    Basophils  (10)
    CL Item
    Platelets  (11)
    CL Item
    Granulocytes (12)
    Item
    Hematology - No Result
    integer
    C0018941 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Haematology - No Result
    Code List
    Hematology - No Result
    CL Item
    No Result (1)
    Hematology - Value
    Item
    Hematology - Value
    text
    C0474523 (UMLS CUI [1])
    Item
    Hematology - Value out of range and NOT clinically significant
    integer
    C0474523 (UMLS CUI [1,1])
    C0438215 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Haematology - Value out of range and NOT clinically significant
    Code List
    Hematology - Value out of range and NOT clinically significant
    CL Item
    Value out of range and NOT clinically significant (2)
    Item
    Hematology - Value out of range and clinically significant
    integer
    C0474523 (UMLS CUI [1,1])
    C0438215 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Haematology - Value out of range and clinically significant
    Code List
    Hematology - Value out of range and clinically significant
    CL Item
    Value out of range and clinically significant (3)
    Item Group
    Day 15 Administration of Study Medications
    C3469597 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    Were the study medications administered at Day 15?
    Item
    Were the study medications administered at Day 15?
    boolean
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item
    If study medication was not administered at Day 15, mark reason(s) why
    integer
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [2])
    If study medication was not administered at Day 8, mark reason(s) why
    Code List
    If study medication was not administered at Day 15, mark reason(s) why
    CL Item
    Hematology (1)
    CL Item
    Non-Hematology (2)
    CL Item
    Other, specify (3)
    If other reason for medication not administered, specify
    Item
    If other reason for medication not administered, specify
    text
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item Group
    Topotecan Administration
    C3469597 (UMLS CUI-1)
    C0146224 (UMLS CUI-2)
    Was the topotecan dose reduced?
    Item
    Was the topotecan dose reduced?
    boolean
    C0146224 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    Item
    If topotecan dose was reduced, mark reason(s) dose was reduced
    integer
    C0146224 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C3146298 (UMLS CUI [1,3])
    If topotecan dose was reduced, mark reason(s) dose was reduced
    Code List
    If topotecan dose was reduced, mark reason(s) dose was reduced
    CL Item
    Hematology (1)
    CL Item
    Non-Hematology, specify (2)
    If other reason topotecan dose was reduced, specify
    Item
    If other reason topotecan dose was reduced, specify
    text
    C0146224 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C3146298 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item
    Topotecan Dose Modification
    integer
    C1707811 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    Topotecan Dose Modification
    Code List
    Topotecan Dose Modification
    CL Item
    No change (2)
    CL Item
    25% reduction (3)
    CL Item
    50% reduction (4)
    CL Item
    Other, specify (5)
    CL Item
    Re-escalation (1)
    If other topotecan dose reduction, specify
    Item
    If other topotecan dose reduction, specify
    integer
    C1707814 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Topotecan scheduled dose
    Item
    Topotecan scheduled dose
    float
    C0146224 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    C0205539 (UMLS CUI [1,3])
    Total mg to be given (Topotecan)
    Item
    Total mg to be given (Topotecan)
    float
    C0178602 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    Date Administered (Topotecan)
    Item
    Date Administered (Topotecan)
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    Start Time (Topotecan)
    Item
    Start Time (Topotecan)
    time
    C1301880 (UMLS CUI [1])
    C0146224 (UMLS CUI [2])
    Stop Time (Topotecan)
    Item
    Stop Time (Topotecan)
    time
    C1522314 (UMLS CUI [1])
    C0146224 (UMLS CUI [2])
    Was complete dose given? (Topotecan)
    Item
    Was complete dose given? (Topotecan)
    boolean
    C3174092 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    If complete dose Topotecan was not given, provide actual mg given:
    Item
    If complete dose Topotecan was not given, provide actual mg given:
    float
    C3174092 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    Item Group
    Gemcitabine Administration
    C3469597 (UMLS CUI-1)
    C0045093 (UMLS CUI-2)
    Was the gemcitabine dose reduced?
    Item
    Was the gemcitabine dose reduced?
    boolean
    C0045093 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    Item
    If gemcitabine dose was reduced, mark reason(s) dose was reduced
    integer
    C0045093 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C3146298 (UMLS CUI [1,3])
    If gemcitabine dose was reduced, mark reason(s) dose was reduced
    Code List
    If gemcitabine dose was reduced, mark reason(s) dose was reduced
    CL Item
    Hematology  (1)
    CL Item
    Non-Hematology, specify (2)
    If other reason gemcitabine dose was reduced, specify
    Item
    If other reason gemcitabine dose was reduced, specify
    text
    C0045093 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C3146298 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item
    Gemcitabine Dose Modification
    integer
    C1707811 (UMLS CUI [1,1])
    C0045093 (UMLS CUI [1,2])
    Gemcitabine Dose Modification
    Code List
    Gemcitabine Dose Modification
    CL Item
    No change  (2)
    CL Item
    25% reduction  (3)
    CL Item
    50% reduction  (4)
    CL Item
    Other, specify (5)
    CL Item
    Re-escalation (1)
    If other gemcitabine dose reduction, specify
    Item
    If other gemcitabine dose reduction, specify
    integer
    C1707814 (UMLS CUI [1,1])
    C0045093 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Gemcitabine scheduled dose
    Item
    Gemcitabine scheduled dose
    float
    C0045093 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    C0205539 (UMLS CUI [1,3])
    Total mg to be given (Gemicitabine)
    Item
    Total mg to be given (Gemicitabine)
    float
    C0178602 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0045093 (UMLS CUI [1,3])
    Date Administered (Gemicitabine)
    Item
    Date Administered (Gemicitabine)
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0045093 (UMLS CUI [1,3])
    Start Time (Gemicitabine)
    Item
    Start Time (Gemicitabine)
    time
    C1301880 (UMLS CUI [1,1])
    C0045093 (UMLS CUI [1,2])
    Stop Time (Gemicitabine)
    Item
    Stop Time (Gemicitabine)
    time
    C1522314 (UMLS CUI [1,1])
    C0045093 (UMLS CUI [1,2])
    Was complete dose given? (Gemicitabine)
    Item
    Was complete dose given? (Gemicitabine)
    boolean
    C3174092 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0045093 (UMLS CUI [1,3])
    If complete dose Gemcitabine was not given, provide actual mg given:
    Item
    If complete dose Gemcitabine was not given, provide actual mg given:
    float
    C3174092 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0045093 (UMLS CUI [1,3])
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