0 Avaliações
ID

22082

Descrição

Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

Link

https://clinicaltrials.gov/ct2/show/NCT01308580

Palavras-chave

Versões (1)
  1. 18/05/2017 18/05/2017 -
Transferido a

18 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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    CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 2

    Inglês

    CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 2

    1 Formulários  
    Visit Information
    Descrição

    Visit Information

    Alias
    UMLS CUI-1
    C0545082
    Date of visit:
    Descrição

    Date of visit

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1]
    C1320303
    dd-mmm-yyyy
    Vital Signs - Day 01 - Not applicable if already done within 8 days prior to infusion.
    Descrição

    Vital Signs - Day 01 - Not applicable if already done within 8 days prior to infusion.

    Alias
    UMLS CUI-1
    C0518766
    Date performed:
    Descrição

    Assessment Date

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1]
    C2985720
    dd-mmm-yyyy
    Weight
    Descrição

    Body Weight

    Tipo de dados

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Systolic Blood Pressure
    Descrição

    Systolic Blood Pressure

    Tipo de dados

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Descrição

    Diastolic Blood Pressure

    Tipo de dados

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart Rate
    Descrição

    Heart Rate

    Tipo de dados

    float

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Performance Status: ECOG
    Descrição

    ECOG Performance Status

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1520224
    Laboratory Tests Hematology - Repeat on Day 01, 08 and Day 15.
    Descrição

    Laboratory Tests Hematology - Repeat on Day 01, 08 and Day 15.

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Date
    Descrição

    Note: Repeat on Day 01, 08, 15.

    Tipo de dados

    text

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1]
    C2826641
    dd-mmm-yyyy
    Hemoglobin
    Descrição

    Hemoglobin

    Tipo de dados

    text

    Unidades de medida
    • g/dL
    Alias
    UMLS CUI [1]
    C0019046
    g/dL
    Platelet Count (Thrombocyte Count)
    Descrição

    Platelets

    Tipo de dados

    float

    Unidades de medida
    • 10^9/L
    Alias
    UMLS CUI [1]
    C0005821
    10^9/L
    White Blood Cell Count (Leukocyte Count)
    Descrição

    White Blood Cell Count

    Tipo de dados

    float

    Unidades de medida
    • 10^9/L
    Alias
    UMLS CUI [1]
    C0023508
    10^9/L
    Neutrophils
    Descrição

    Neutrophils

    Tipo de dados

    float

    Unidades de medida
    • 10^9/L
    Alias
    UMLS CUI [1]
    C0948762
    10^9/L
    Lymphocytes
    Descrição

    Lymphocytes

    Tipo de dados

    float

    Unidades de medida
    • 10^9/L
    Alias
    UMLS CUI [1]
    C0024264
    10^9/L
    Monocytes
    Descrição

    Monocytes

    Tipo de dados

    float

    Unidades de medida
    • 10^9/L
    Alias
    UMLS CUI [1]
    C0026473
    10^9/L
    Eosinophils
    Descrição

    Eosinophils

    Tipo de dados

    float

    Unidades de medida
    • 10^9/L
    Alias
    UMLS CUI [1]
    C0200638
    10^9/L
    Basophils
    Descrição

    Basophils

    Tipo de dados

    float

    Unidades de medida
    • 10^9/L
    Alias
    UMLS CUI [1]
    C0200641
    10^9/L
    Laboratory Tests Biochemistry - Repeat on Day 08, 15 (Sodium, Potassium, Calcium, Phosphorus, Blood Urea Nitrogen, Magnesium, Creatinine)
    Descrição

    Laboratory Tests Biochemistry - Repeat on Day 08, 15 (Sodium, Potassium, Calcium, Phosphorus, Blood Urea Nitrogen, Magnesium, Creatinine)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0005477
    Date
    Descrição

    Note: Repeat on Day 01, 08, 15.

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C2826641
    UMLS CUI [1,2]
    C0005477
    dd-mmm-yyyy
    Sodium
    Descrição

    Note: Repeat on Day 01, 08, 15.

    Tipo de dados

    float

    Unidades de medida
    • mmol/L
    Alias
    UMLS CUI [1]
    C0337443
    mmol/L
    Potassium
    Descrição

    Note: Repeat on Day 01, 08, 15.

    Tipo de dados

    float

    Unidades de medida
    • mmol/L
    Alias
    UMLS CUI [1]
    C0202194
    mmol/L
    Calcium
    Descrição

    Note: Repeat on Day 01, 08, 15.

    Tipo de dados

    float

    Unidades de medida
    • mmol/L
    Alias
    UMLS CUI [1]
    C0201925
    mmol/L
    Phosphorus
    Descrição

    Note: Repeat on Day 01, 08, 15.

    Tipo de dados

    float

    Unidades de medida
    • mmol/L
    Alias
    UMLS CUI [1]
    C0031705
    mmol/L
    Blood urea nitrogen
    Descrição

    Note: Repeat on Day 01, 08, 15.

    Tipo de dados

    float

    Unidades de medida
    • mmol/L
    Alias
    UMLS CUI [1]
    C0005845
    mmol/L
    Magnesium
    Descrição

    Note: Repeat on Day 01, 08, 15.

    Tipo de dados

    float

    Unidades de medida
    • mmol/L
    Alias
    UMLS CUI [1]
    C0373675
    mmol/L
    Total Proteins
    Descrição

    Total Proteins

    Tipo de dados

    float

    Unidades de medida
    • g/L
    Alias
    UMLS CUI [1]
    C0555903
    g/L
    Albumin
    Descrição

    Albumin

    Tipo de dados

    float

    Unidades de medida
    • g/L
    Alias
    UMLS CUI [1]
    C0201838
    g/L
    Glucose
    Descrição

    Blood Glucose

    Tipo de dados

    float

    Unidades de medida
    • mmol/L
    Alias
    UMLS CUI [1]
    C0202042
    mmol/L
    AST (SGOT - ASAT)
    Descrição

    AST

    Tipo de dados

    float

    Unidades de medida
    • U/L
    Alias
    UMLS CUI [1]
    C0201899
    U/L
    AST (SGOT - ASAT): Normal Range - Upper Limit
    Descrição

    AST: Upper Limit

    Tipo de dados

    float

    Unidades de medida
    • U/L
    Alias
    UMLS CUI [1,1]
    C0201899
    UMLS CUI [1,2]
    C1519815
    U/L
    ALT (SGPT - ALAT)
    Descrição

    ALT

    Tipo de dados

    float

    Unidades de medida
    • U/L
    Alias
    UMLS CUI [1]
    C0201836
    U/L
    ALT (SGPT - ALAT): Normal Range - Upper Limit
    Descrição

    ALT: Upper Limit

    Tipo de dados

    float

    Unidades de medida
    • U/L
    Alias
    UMLS CUI [1,1]
    C0201836
    UMLS CUI [1,2]
    C1519815
    U/L
    Alkaline Phosphatase
    Descrição

    Alkaline Phosphatase

    Tipo de dados

    float

    Unidades de medida
    • U/L
    Alias
    UMLS CUI [1]
    C0201850
    U/L
    Alkaline Phosphatase: Normal Range - Upper Limit
    Descrição

    Alkaline Phosphatase: Upper Limit

    Tipo de dados

    float

    Unidades de medida
    • U/L
    Alias
    UMLS CUI [1,1]
    C0201850
    UMLS CUI [1,2]
    C1519815
    U/L
    Total Bilirubin
    Descrição

    Total Bilirubin

    Tipo de dados

    float

    Unidades de medida
    • umol/L
    Alias
    UMLS CUI [1]
    C0201913
    umol/L
    Total Bilirubin: Normal Range - Upper Limit
    Descrição

    Total Bilirubin: Upper Limit

    Tipo de dados

    float

    Unidades de medida
    • umol/L
    Alias
    UMLS CUI [1,1]
    C0201913
    UMLS CUI [1,2]
    C1519815
    umol/L
    Creatinine
    Descrição

    Note: Repeat on Day 01, 08, 15.

    Tipo de dados

    float

    Unidades de medida
    • umol/L
    Alias
    UMLS CUI [1]
    C0201976
    umol/L
    Creatinine: Normal Range - Upper Limit
    Descrição

    Note: Repeat on Day 01, 08, 15.

    Tipo de dados

    float

    Unidades de medida
    • umol/L
    Alias
    UMLS CUI [1,1]
    C0201976
    UMLS CUI [1,2]
    C1519815
    umol/L
    Lactate Dehydrogenase
    Descrição

    Lactate Dehydrogenase

    Tipo de dados

    float

    Unidades de medida
    • U/L
    Alias
    UMLS CUI [1]
    C0202113
    U/L
    Lactate Dehydrogenase: Normal Range - Upper Limit
    Descrição

    Lactate Dehydrogenase: Upper Limit

    Tipo de dados

    float

    Unidades de medida
    • U/L
    Alias
    UMLS CUI [1,1]
    C0202113
    UMLS CUI [1,2]
    C1519815
    U/L
    Electrocardiagram (12 Lead)
    Descrição

    Electrocardiagram (12 Lead)

    Alias
    UMLS CUI-1
    C1623258
    Date performed:
    Descrição

    Date of ECG

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1]
    C2826640
    dd-mmm-yyyy
    Interpretation
    Descrição

    ECG finding

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0438154
    Interpretation - If abnormal, clinically significant?
    Descrição

    Note: If abnormal, clinically significant, record on the AE Form.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0438154
    UMLS CUI [1,2]
    C2826279
    Medication - Pre Medication: Record all medications that the subject has taken prior to the Day 01 study treatment as premedication.
    Descrição

    Medication - Pre Medication: Record all medications that the subject has taken prior to the Day 01 study treatment as premedication.

    Alias
    UMLS CUI-1
    C0033045
    Drug/Medication (Brand or generic name)
    Descrição

    Medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0013227
    Reason
    Descrição

    Indication

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3146298
    Dosage (Total daily dose)
    Descrição

    Total daily dose

    Tipo de dados

    float

    Alias
    UMLS CUI [1]
    C2348070
    Dose Unit
    Descrição

    Dose Unit

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826646
    Route
    Descrição

    Administration Route

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start Date
    Descrição

    Premedication: Start Date

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0033045
    dd-mmm-yyyy
    End Date
    Descrição

    Premedication: End Date

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0033045
    dd-mmm-yyyy
    Investigational Product Administration - Prednisone/ Prednisolone
    Descrição

    Investigational Product Administration - Prednisone/ Prednisolone

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C1533734
    UMLS CUI-3
    C0032952
    Intended Daily Dose
    Descrição

    Prednisone: Intended Daily Dose

    Tipo de dados

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0032952
    UMLS CUI [1,2]
    C1283828
    UMLS CUI [1,3]
    C2348070
    mg
    Actual Total Dose
    Descrição

    Prednisone: Actual Total Dose

    Tipo de dados

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0032952
    UMLS CUI [1,2]
    C3174092
    mg
    Number of day with no intake
    Descrição

    Prednisone: Number of day with no intake

    Tipo de dados

    float

    Alias
    UMLS CUI [1,1]
    C0032952
    UMLS CUI [1,2]
    C0449788
    UMLS CUI [1,3]
    C0439228
    UMLS CUI [1,4]
    C0332453
    Investigational Product Administration - Cabazitaxel
    Descrição

    Investigational Product Administration - Cabazitaxel

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C1533734
    UMLS CUI-3
    C2830183
    Scheduled Period
    Descrição

    Cabazitaxel: Scheduled Period

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2830183
    UMLS CUI [1,2]
    C0205539
    Batch Number
    Descrição

    Cabazitaxel: Batch Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2830183
    UMLS CUI [1,2]
    C3641829
    Start Date
    Descrição

    Cabazitaxel: Start Date

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C2830183
    UMLS CUI [1,2]
    C0808070
    dd-mmm-yyyy
    Intended Dose
    Descrição

    Cabazitaxel: Intended Dose

    Tipo de dados

    float

    Unidades de medida
    • mg/m^2
    Alias
    UMLS CUI [1,1]
    C2830183
    UMLS CUI [1,2]
    C1283828
    UMLS CUI [1,3]
    C2348070
    mg/m^2
    Administration Route
    Descrição

    Cabazitaxel: Administration Route

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2830183
    UMLS CUI [1,2]
    C0013153
    Actual Dose
    Descrição

    Cabazitaxel: Actual Dose

    Tipo de dados

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C2830183
    UMLS CUI [1,2]
    C3174092
    mg
    If dose interrupted and readministered, please report the information below: Cabazitaxel
    Descrição

    If dose interrupted and readministered, please report the information below: Cabazitaxel

    Alias
    UMLS CUI-1
    C1512900
    UMLS CUI-2
    C2830183
    Scheduled Period
    Descrição

    Interruption Cabazitaxel: Scheduled Period

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1512900
    UMLS CUI [1,2]
    C2830183
    UMLS CUI [1,3]
    C0205539
    Batch Number
    Descrição

    Interruption Cabazitaxel: Batch Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1512900
    UMLS CUI [1,2]
    C2830183
    UMLS CUI [1,3]
    C3641829
    Start Date
    Descrição

    Interruption Cabazitaxel: Start Date

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C1512900
    UMLS CUI [1,2]
    C2830183
    UMLS CUI [1,3]
    C0808070
    dd-mmm-yyyy
    Administration Route
    Descrição

    Interruption Cabazitaxel: Administration Route

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1512900
    UMLS CUI [1,2]
    C2830183
    UMLS CUI [1,3]
    C0013153
    Actual Dose
    Descrição

    Interruption Cabazitaxel: Actual Dose

    Tipo de dados

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C1512900
    UMLS CUI [1,2]
    C2830183
    UMLS CUI [1,3]
    C3174092
    mg
    Circulating free plasma DNA - Blood Sampling
    Descrição

    Circulating free plasma DNA - Blood Sampling

    Alias
    UMLS CUI-1
    C4289789
    UMLS CUI-2
    C0005834
    Date of Sample
    Descrição

    Sample ID: Z02 - Theoretical Time: Cycle 2, Day 01

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C4289789
    UMLS CUI [1,2]
    C1317250
    dd-mmm-yyyy
    Macroscopic Hematuria
    Descrição

    Macroscopic Hematuria

    Alias
    UMLS CUI-1
    C0473237
    Does the patient experience Macroscopic Hematuria during this cycle?
    Descrição

    Macroscopic Hematuria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0473237
    If YES, specify the cause:
    Descrição

    * Please report the cause as AE ** Please report "Macroscopic Hematuria" as AE

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0473237
    UMLS CUI [1,2]
    C0015127
    If YES and OTHER, specify:
    Descrição

    Macroscopic Hematuria: Cause Specification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0473237
    UMLS CUI [1,2]
    C0015127
    UMLS CUI [1,3]
    C2348235
    Did you perform specific exams to document the cause?
    Descrição

    Note: If YES, please report the exam in the "OTHER PROCEDURES" page.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0473237
    UMLS CUI [1,2]
    C0582103
    Tumor Assessment - Recist 1.1 (to follow until radiological progression) - Target Lesion (Previously identified). Note: If new lesion appears, please report it on the specific page "Tumor assessment (new lesion)".
    Descrição

    Tumor Assessment - Recist 1.1 (to follow until radiological progression) - Target Lesion (Previously identified). Note: If new lesion appears, please report it on the specific page "Tumor assessment (new lesion)".

    Alias
    UMLS CUI-1
    C3889740
    UMLS CUI-2
    C2986546
    Lesion Number - The Lesion number should be entered and saved to display "Lesion location" and "Lesion Description (Subsite). The lesion number entered should be similar to the lesion number from "Target Lesion (at Baseline)".
    Descrição

    Target Lesion Number

    Tipo de dados

    float

    Alias
    UMLS CUI [1,1]
    C0449791
    UMLS CUI [1,2]
    C2986546
    Lesion Location
    Descrição

    Target Lesion Location

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0450429
    UMLS CUI [1,2]
    C2986546
    Lesion Description (Subsite)
    Descrição

    Target Lesion Description

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C2986546
    Date of Assessment
    Descrição

    Target Lesion Assessment Date

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C2986546
    UMLS CUI [1,2]
    C2985720
    dd-mmm-yyyy
    Method of Tumor Measurement
    Descrição

    Target Lesion Method of Measurement

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1299991
    UMLS CUI [1,2]
    C2986546
    Measurement of Target Lesion: Diameter
    Descrição

    Target Lesion Diameter

    Tipo de dados

    float

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1,1]
    C2986546
    UMLS CUI [1,2]
    C1301886
    mm
    Tumor Assessment - Recist 1.1 (to follow until radiological progression) - Non-Target Lesion (Previously identified). Note: If new lesion appears, please report it on the specific page "Tumor assessment (new lesion)".
    Descrição

    Tumor Assessment - Recist 1.1 (to follow until radiological progression) - Non-Target Lesion (Previously identified). Note: If new lesion appears, please report it on the specific page "Tumor assessment (new lesion)".

    Alias
    UMLS CUI-1
    C3889740
    UMLS CUI-2
    C2986547
    Date of Assessment
    Descrição

    Non-Target Lesion Assessment Date

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C2986547
    dd-mmm-yyyy
    Overall Response of Non-Target Lesions:
    Descrição

    Overall Response of Non-Target Lesion

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3272903
    UMLS CUI [1,2]
    C2986547
    If Response is NE, Please Specify the Reason:
    Descrição

    Overall Response of Non-Target Lesion Specification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3272903
    UMLS CUI [1,2]
    C2986547
    UMLS CUI [1,3]
    C2348235
    If Response is PD, Please Specify the Concerned Non-Target Lesion(s) Below:
    Descrição

    Non-Target Lesion Progressive Disease Location

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2986547
    UMLS CUI [1,2]
    C1335499
    UMLS CUI [1,3]
    C0450429
    Tumor Assessment - New Lesion
    Descrição

    Tumor Assessment - New Lesion

    Alias
    UMLS CUI-1
    C3889740
    UMLS CUI-2
    C2986548
    Lesion Location
    Descrição

    New Lesion Location

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2986548
    UMLS CUI [1,2]
    C0450429
    New Lesion Description (Specify Exact Location)
    Descrição

    New Lesion Description

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2986548
    UMLS CUI [1,2]
    C0678257
    Date of Assessment
    Descrição

    New Lesion Assessment Date

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C2986548
    UMLS CUI [1,2]
    C2985720
    dd-mmm-yyyy
    Method of Tumor Measurement
    Descrição

    New Lesion Method of Measurement

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2986548
    UMLS CUI [1,2]
    C1299991
    Bone Check (to follow until radiological progression)
    Descrição

    Bone Check (to follow until radiological progression)

    Alias
    UMLS CUI-1
    C0203668
    In case of Bone scan done, indicate the total number of Hot spots:
    Descrição

    Bone Scan Hot Spot

    Tipo de dados

    float

    Alias
    UMLS CUI [1,1]
    C0203668
    UMLS CUI [1,2]
    C0203637
    Tumor Markers - to follow until PSA progression - to be performed prior to the next study drug infusion.
    Descrição

    Tumor Markers - to follow until PSA progression - to be performed prior to the next study drug infusion.

    Alias
    UMLS CUI-1
    C0041365
    Date of evaluation
    Descrição

    Tumor Markers: Assessment Date

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C0041365
    UMLS CUI [1,2]
    C2985720
    dd-mmm-yyyy
    Test: PSA
    Descrição

    Tumor Markers: PSA Test

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0041365
    UMLS CUI [1,2]
    C0201544
    PSA Test Value
    Descrição

    Tumor Markers: PSA Test Value

    Tipo de dados

    float

    Alias
    UMLS CUI [1,1]
    C0041365
    UMLS CUI [1,2]
    C0201544
    UMLS CUI [1,3]
    C1275372
    PSA Test: Unit
    Descrição

    Tumor Markers: PSA Test Unit

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0041365
    UMLS CUI [1,2]
    C0201544
    UMLS CUI [1,3]
    C1519795
    PSA Test: Normal Range - Lower Limit
    Descrição

    Tumor Markers: PSA Test Lower Limit

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0041365
    UMLS CUI [1,2]
    C0201544
    UMLS CUI [1,3]
    C1518030
    PSA Test: Normal Range - Upper Limit
    Descrição

    Tumor Markers: PSA Test Upper Limit

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0041365
    UMLS CUI [1,2]
    C0201544
    UMLS CUI [1,3]
    C1519815
    Present Pain Intensity and Analgesic Questionnaire for Cancer Pain (to follow until the first documented progression).
    Descrição

    Present Pain Intensity and Analgesic Questionnaire for Cancer Pain (to follow until the first documented progression).

    Alias
    UMLS CUI-1
    C0596240
    UMLS CUI-2
    C0034394
    Was the Patient questionnaire completed for this visit?
    Descrição

    Cancer Pain Questionnaire: Complete

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0596240
    UMLS CUI [1,2]
    C0034394
    UMLS CUI [1,3]
    C0205197
    If NO, please specify the primary reason:
    Descrição

    Cancer Pain Questionnaire: Primary Reason

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0596240
    UMLS CUI [1,2]
    C0034394
    UMLS CUI [1,3]
    C1549995
    If NO and OTHER, Specify:
    Descrição

    Cancer Pain Questionnaire: Primary Reason Specification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0596240
    UMLS CUI [1,2]
    C0034394
    UMLS CUI [1,3]
    C1549995
    UMLS CUI [1,4]
    C2348235
    If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Date
    Descrição

    Note: Repeat on Day 01, 02, 03, 04, 05, 06, 07.

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C1161170
    UMLS CUI [1,2]
    C2985720
    dd-mmm-yyyy
    If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Present Pain Intensity
    Descrição

    Note: Repeat on Day 01, 02, 03, 04, 05, 06, 07.

    Tipo de dados

    float

    Alias
    UMLS CUI [1]
    C1320357
    If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Analgesic Score
    Descrição

    Note: Repeat on Day 01, 02, 03, 04, 05, 06, 07.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3202977
    UMLS CUI [1,2]
    C0449820
    Disease Status
    Descrição

    Disease Status

    Alias
    UMLS CUI-1
    C0699749
    Disease Status (tick one box only):
    Descrição

    Disease Status

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0699749
    Disease Status: Progression - please specify the assessment:
    Descrição

    Progressive Disease: Assessment

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1335499
    UMLS CUI [1,2]
    C0220825
    FACT P Questionnaire (to follow until the first documented progression).
    Descrição

    FACT P Questionnaire (to follow until the first documented progression).

    Alias
    UMLS CUI-1
    C3641634
    Was the assessment performed at this visit?
    Descrição

    FACT P Questionnaire

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3641634
    If NO, please specify the primary reason:
    Descrição

    FACT P Questionnaire: Primary Reason

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1549995
    UMLS CUI [1,2]
    C3641634
    If OTHER, Specify:
    Descrição

    FACT P Questionnaire: Primary Reason Specification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1549995
    UMLS CUI [1,2]
    C3641634
    UMLS CUI [1,3]
    C2348235
    If YES, Please indicate how true each statement has been for the patient during the past 7 days: Date performed
    Descrição

    FACT P Questionnaire: Date

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1549995
    dd-mmm-yyyy
    FACT P Questionnaire - Physical Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
    Descrição

    FACT P Questionnaire - Physical Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.

    Alias
    UMLS CUI-1
    C0517226
    I have a lack of energy.
    Descrição

    Lack of Energy

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C4048330
    I have nausea.
    Descrição

    Nausea

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0027497
    Because of my physical condition, I have trouble meeting the needs of my family
    Descrição

    Trouble meeting needs of family

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C4287855
    I have Pain.
    Descrição

    Pain

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0030193
    I am bothered by side effects of treatment.
    Descrição

    Bothered by side effects of treatment

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C4289375
    I feel ill.
    Descrição

    Illness

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0221423
    I am forced to spend time in bed.
    Descrição

    Time spend in bed

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C4289366
    FACT P Questionnaire - Social/ Family Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
    Descrição

    FACT P Questionnaire - Social/ Family Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.

    Alias
    UMLS CUI-1
    C3476515
    I feel close to my friends.
    Descrição

    Feel Close to Friends

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984048
    I get emotional support from my friends.
    Descrição

    Emotional Support from friends

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0600015
    UMLS CUI [1,2]
    C0079382
    I get support from my friends.
    Descrição

    Receive Support from Friends

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984072
    My family has accepted my illness.
    Descrição

    Illness acceptancy by family

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0278069
    UMLS CUI [1,2]
    C0015576
    I am satisfied with my family communication about my illness.
    Descrição

    Satisfied with Family Communication

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984054
    I feel close to my partner (or the person who is my main support).
    Descrição

    Feeling close to partner

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984059
    (If the patient prefers not to answer to the following question, please tick for this question NOT ANSWERED.) I am satisfied with my sex life.
    Descrição

    Satisfied with Sex Life

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984060
    FACT P Questionnaire - Emotional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
    Descrição

    FACT P Questionnaire - Emotional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.

    Alias
    UMLS CUI-1
    C2984554
    I feel sad.
    Descrição

    Feeling sad

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3536794
    I am satisfied with how I am coping with my illness.
    Descrição

    Coping

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0009967
    I am losing hope in the fight against my illness.
    Descrição

    Losing hope against illness

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984056
    I feel nervous.
    Descrição

    Feeling nervous

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0849963
    I worry about dying.
    Descrição

    Worry About Dying

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984076
    I worry that my condition will get worse.
    Descrição

    Worry About Worsening Condition

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984075
    FACT P Quesionnaire - Functional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
    Descrição

    FACT P Quesionnaire - Functional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.

    Alias
    UMLS CUI-1
    C3483376
    I am able to work (include work at home).
    Descrição

    Able to work

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984044
    My Work (include work at home) is fulfilling.
    Descrição

    Work is fulfilling

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984074
    I am able to enjoy life.
    Descrição

    Able to enjoy life

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2984051
    I have accepted my illness.
    Descrição

    Acceptance of illness

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0278069
    I am sleeping well.
    Descrição

    Sleeping behaviour

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0474396
    I am enjoying the things I usually do for fun.
    Descrição

    Anhedonia

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0178417
    I am content with the quality of my life right now.
    Descrição

    Quality of life

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0034380
    FACT P Questionnaire - Additional Concerns: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
    Descrição

    FACT P Questionnaire - Additional Concerns: If YES, Please indicate how true each statement has been for the patient during the past 7 days.

    Alias
    UMLS CUI-1
    C3482667
    I am losing weight.
    Descrição

    Losing Weight

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1262477
    I have a good appetite.
    Descrição

    Appetite

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0003618
    I have aches and pains that bother me.
    Descrição

    Bothered by pain

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3830278
    UMLS CUI [1,2]
    C0030193
    I have certain parts of my body where I experience pain.
    Descrição

    Painful Body Parts

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3641636
    My pain keeps me from doing things I want to do.
    Descrição

    Pain Keeps Me From Doing Things I Want to Do

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3641680
    I am satisfied with my present comfort level.
    Descrição

    Comfort Level

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0517225
    I am able to feel like a man.
    Descrição

    Feel like a man

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3641638
    I have trouble moving my bowels.
    Descrição

    Trouble Moving Bowels

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3641639
    I have difficulty urinating.
    Descrição

    Difficulty urinating

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0241705
    I urinate more frequently than usual.
    Descrição

    Frequency of urination

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2584336
    My problems with urinating limit my activities.
    Descrição

    Activities Limited by Urination Problems

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3641641
    I am able to have and maintain an erection.
    Descrição

    Erection

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0030847
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    CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 2

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Visit Information
    C0545082 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit:
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Vital Signs - Day 01 - Not applicable if already done within 8 days prior to infusion.
    C0518766 (UMLS CUI-1)
    Assessment Date
    Item
    Date performed:
    date
    C2985720 (UMLS CUI [1])
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    float
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    float
    C0428883 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    float
    C0018810 (UMLS CUI [1])
    Item
    Performance Status: ECOG
    integer
    C1520224 (UMLS CUI [1])
    ECOG Performance Status
    Code List
    Performance Status: ECOG
    CL Item
    0 (1)
    CL Item
    1 (2)
    CL Item
    2 (3)
    CL Item
    3 (4)
    CL Item
    4 (5)
    Item Group
    Laboratory Tests Hematology - Repeat on Day 01, 08 and Day 15.
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Laboratory Test Date
    Item
    Date
    text
    C2826641 (UMLS CUI [1])
    Hemoglobin
    Item
    Hemoglobin
    text
    C0019046 (UMLS CUI [1])
    Platelets
    Item
    Platelet Count (Thrombocyte Count)
    float
    C0005821 (UMLS CUI [1])
    White Blood Cell Count
    Item
    White Blood Cell Count (Leukocyte Count)
    float
    C0023508 (UMLS CUI [1])
    Neutrophils
    Item
    Neutrophils
    float
    C0948762 (UMLS CUI [1])
    Lymphocytes
    Item
    Lymphocytes
    float
    C0024264 (UMLS CUI [1])
    Monocytes
    Item
    Monocytes
    float
    C0026473 (UMLS CUI [1])
    Eosinophils
    Item
    Eosinophils
    float
    C0200638 (UMLS CUI [1])
    Basophils
    Item
    Basophils
    float
    C0200641 (UMLS CUI [1])
    Item Group
    Laboratory Tests Biochemistry - Repeat on Day 08, 15 (Sodium, Potassium, Calcium, Phosphorus, Blood Urea Nitrogen, Magnesium, Creatinine)
    C0022885 (UMLS CUI-1)
    C0005477 (UMLS CUI-2)
    Laboratory Test Biochemistry Date
    Item
    Date
    date
    C2826641 (UMLS CUI [1,1])
    C0005477 (UMLS CUI [1,2])
    Sodium
    Item
    Sodium
    float
    C0337443 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    float
    C0202194 (UMLS CUI [1])
    Calcium
    Item
    Calcium
    float
    C0201925 (UMLS CUI [1])
    Phosphorus
    Item
    Phosphorus
    float
    C0031705 (UMLS CUI [1])
    Blood Urea Nitrogen
    Item
    Blood urea nitrogen
    float
    C0005845 (UMLS CUI [1])
    Magnesium
    Item
    Magnesium
    float
    C0373675 (UMLS CUI [1])
    Total Proteins
    Item
    Total Proteins
    float
    C0555903 (UMLS CUI [1])
    Albumin
    Item
    Albumin
    float
    C0201838 (UMLS CUI [1])
    Blood Glucose
    Item
    Glucose
    float
    C0202042 (UMLS CUI [1])
    AST
    Item
    AST (SGOT - ASAT)
    float
    C0201899 (UMLS CUI [1])
    AST: Upper Limit
    Item
    AST (SGOT - ASAT): Normal Range - Upper Limit
    float
    C0201899 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    ALT
    Item
    ALT (SGPT - ALAT)
    float
    C0201836 (UMLS CUI [1])
    ALT: Upper Limit
    Item
    ALT (SGPT - ALAT): Normal Range - Upper Limit
    float
    C0201836 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Alkaline Phosphatase
    Item
    Alkaline Phosphatase
    float
    C0201850 (UMLS CUI [1])
    Alkaline Phosphatase: Upper Limit
    Item
    Alkaline Phosphatase: Normal Range - Upper Limit
    float
    C0201850 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Total Bilirubin
    Item
    Total Bilirubin
    float
    C0201913 (UMLS CUI [1])
    Total Bilirubin: Upper Limit
    Item
    Total Bilirubin: Normal Range - Upper Limit
    float
    C0201913 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Creatinine
    Item
    Creatinine
    float
    C0201976 (UMLS CUI [1])
    Creatinine
    Item
    Creatinine: Normal Range - Upper Limit
    float
    C0201976 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Lactate Dehydrogenase
    Item
    Lactate Dehydrogenase
    float
    C0202113 (UMLS CUI [1])
    Lactate Dehydrogenase: Upper Limit
    Item
    Lactate Dehydrogenase: Normal Range - Upper Limit
    float
    C0202113 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Item Group
    Electrocardiagram (12 Lead)
    C1623258 (UMLS CUI-1)
    Date of ECG
    Item
    Date performed:
    date
    C2826640 (UMLS CUI [1])
    Item
    Interpretation
    text
    C0438154 (UMLS CUI [1])
    ECG finding
    Code List
    Interpretation
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    ECG finding abnormal
    Item
    Interpretation - If abnormal, clinically significant?
    boolean
    C0438154 (UMLS CUI [1,1])
    C2826279 (UMLS CUI [1,2])
    Item Group
    Medication - Pre Medication: Record all medications that the subject has taken prior to the Day 01 study treatment as premedication.
    C0033045 (UMLS CUI-1)
    Medication
    Item
    Drug/Medication (Brand or generic name)
    text
    C0013227 (UMLS CUI [1])
    Item
    Reason
    text
    C3146298 (UMLS CUI [1])
    Indication
    Code List
    Reason
    CL Item
    Prophylaxis (Prophylaxis)
    Total daily dose
    Item
    Dosage (Total daily dose)
    float
    C2348070 (UMLS CUI [1])
    Dose Unit
    Item
    Dose Unit
    text
    C2826646 (UMLS CUI [1])
    Administration Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Premedication: Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0033045 (UMLS CUI [1,2])
    Premedication: End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C0033045 (UMLS CUI [1,2])
    Item Group
    Investigational Product Administration - Prednisone/ Prednisolone
    C0304229 (UMLS CUI-1)
    C1533734 (UMLS CUI-2)
    C0032952 (UMLS CUI-3)
    Prednisone: Intended Daily Dose
    Item
    Intended Daily Dose
    float
    C0032952 (UMLS CUI [1,1])
    C1283828 (UMLS CUI [1,2])
    C2348070 (UMLS CUI [1,3])
    Prednisone: Actual Total Dose
    Item
    Actual Total Dose
    float
    C0032952 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    Prednisone: Number of day with no intake
    Item
    Number of day with no intake
    float
    C0032952 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    C0439228 (UMLS CUI [1,3])
    C0332453 (UMLS CUI [1,4])
    Item Group
    Investigational Product Administration - Cabazitaxel
    C0304229 (UMLS CUI-1)
    C1533734 (UMLS CUI-2)
    C2830183 (UMLS CUI-3)
    Item
    Scheduled Period
    text
    C2830183 (UMLS CUI [1,1])
    C0205539 (UMLS CUI [1,2])
    Cabazitaxel: Scheduled Period
    Code List
    Scheduled Period
    CL Item
    Day 01 (Day 01)
    Cabazitaxel: Batch Number
    Item
    Batch Number
    text
    C2830183 (UMLS CUI [1,1])
    C3641829 (UMLS CUI [1,2])
    Cabazitaxel: Start Date
    Item
    Start Date
    date
    C2830183 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Cabazitaxel: Intended Dose
    Item
    Intended Dose
    float
    C2830183 (UMLS CUI [1,1])
    C1283828 (UMLS CUI [1,2])
    C2348070 (UMLS CUI [1,3])
    Item
    Administration Route
    text
    C2830183 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Cabazitaxel: Administration Route
    Code List
    Administration Route
    CL Item
    IV (IV)
    Cabazitaxel: Actual Dose
    Item
    Actual Dose
    float
    C2830183 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    Item Group
    If dose interrupted and readministered, please report the information below: Cabazitaxel
    C1512900 (UMLS CUI-1)
    C2830183 (UMLS CUI-2)
    Interruption Cabazitaxel: Scheduled Period
    Item
    Scheduled Period
    text
    C1512900 (UMLS CUI [1,1])
    C2830183 (UMLS CUI [1,2])
    C0205539 (UMLS CUI [1,3])
    Interruption Cabazitaxel: Batch Number
    Item
    Batch Number
    text
    C1512900 (UMLS CUI [1,1])
    C2830183 (UMLS CUI [1,2])
    C3641829 (UMLS CUI [1,3])
    Interruption Cabazitaxel: Start Date
    Item
    Start Date
    date
    C1512900 (UMLS CUI [1,1])
    C2830183 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Item
    Administration Route
    text
    C1512900 (UMLS CUI [1,1])
    C2830183 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    Interruption Cabazitaxel: Administration Route
    Code List
    Administration Route
    CL Item
    IV (IV)
    Interruption Cabazitaxel: Actual Dose
    Item
    Actual Dose
    float
    C1512900 (UMLS CUI [1,1])
    C2830183 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    Item Group
    Circulating free plasma DNA - Blood Sampling
    C4289789 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    (Circulating free plasma DNA: Date of Sample
    Item
    Date of Sample
    date
    C4289789 (UMLS CUI [1,1])
    C1317250 (UMLS CUI [1,2])
    Item Group
    Macroscopic Hematuria
    C0473237 (UMLS CUI-1)
    Macroscopic Hematuria
    Item
    Does the patient experience Macroscopic Hematuria during this cycle?
    boolean
    C0473237 (UMLS CUI [1])
    Item
    If YES, specify the cause:
    text
    C0473237 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    Macroscopic Hematuria: Cause
    Code List
    If YES, specify the cause:
    CL Item
    Local infection* (Local infection*)
    CL Item
    Bladder mucositis (non infectious)* (Bladder mucositis (non infectious)*)
    CL Item
    Local progression/ obstruction** (Local progression/ obstruction**)
    CL Item
    Anticoagulation/ Aspirin therapy** (Anticoagulation/ Aspirin therapy**)
    CL Item
    Thrombocytopenia** (Thrombocytopenia**)
    CL Item
    No cause identified** (No cause identified**)
    CL Item
    Stones* (Stones*)
    CL Item
    Non steroid anti-inflammatory drug** (Non steroid anti-inflammatory drug**)
    CL Item
    Other (Other)
    Macroscopic Hematuria: Cause Specification
    Item
    If YES and OTHER, specify:
    text
    C0473237 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Macroscopic Hematuria: Examination
    Item
    Did you perform specific exams to document the cause?
    boolean
    C0473237 (UMLS CUI [1,1])
    C0582103 (UMLS CUI [1,2])
    Item Group
    Tumor Assessment - Recist 1.1 (to follow until radiological progression) - Target Lesion (Previously identified). Note: If new lesion appears, please report it on the specific page "Tumor assessment (new lesion)".
    C3889740 (UMLS CUI-1)
    C2986546 (UMLS CUI-2)
    Target Lesion Number
    Item
    Lesion Number - The Lesion number should be entered and saved to display "Lesion location" and "Lesion Description (Subsite). The lesion number entered should be similar to the lesion number from "Target Lesion (at Baseline)".
    float
    C0449791 (UMLS CUI [1,1])
    C2986546 (UMLS CUI [1,2])
    Target Lesion Location
    Item
    Lesion Location
    text
    C0450429 (UMLS CUI [1,1])
    C2986546 (UMLS CUI [1,2])
    Target Lesion Description
    Item
    Lesion Description (Subsite)
    text
    C0678257 (UMLS CUI [1,1])
    C2986546 (UMLS CUI [1,2])
    Target Lesion Assessment Date
    Item
    Date of Assessment
    date
    C2986546 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Target Lesion Method of Measurement
    Item
    Method of Tumor Measurement
    text
    C1299991 (UMLS CUI [1,1])
    C2986546 (UMLS CUI [1,2])
    Target Lesion Diameter
    Item
    Measurement of Target Lesion: Diameter
    float
    C2986546 (UMLS CUI [1,1])
    C1301886 (UMLS CUI [1,2])
    Item Group
    Tumor Assessment - Recist 1.1 (to follow until radiological progression) - Non-Target Lesion (Previously identified). Note: If new lesion appears, please report it on the specific page "Tumor assessment (new lesion)".
    C3889740 (UMLS CUI-1)
    C2986547 (UMLS CUI-2)
    Non-Target Lesion Assessment Date
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1,1])
    C2986547 (UMLS CUI [1,2])
    Item
    Overall Response of Non-Target Lesions:
    text
    C3272903 (UMLS CUI [1,1])
    C2986547 (UMLS CUI [1,2])
    Overall Response of Non-Target Lesion
    Code List
    Overall Response of Non-Target Lesions:
    CL Item
    CR (CR)
    CL Item
    Non CR/Non PD (Non CR/Non PD)
    CL Item
    PD (PD)
    CL Item
    NE (NE)
    Overall Response of Non-Target Lesion Specification
    Item
    If Response is NE, Please Specify the Reason:
    text
    C3272903 (UMLS CUI [1,1])
    C2986547 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Non-Target Lesion Progressive Disease Location
    Item
    If Response is PD, Please Specify the Concerned Non-Target Lesion(s) Below:
    text
    C2986547 (UMLS CUI [1,1])
    C1335499 (UMLS CUI [1,2])
    C0450429 (UMLS CUI [1,3])
    Item Group
    Tumor Assessment - New Lesion
    C3889740 (UMLS CUI-1)
    C2986548 (UMLS CUI-2)
    New Lesion Location
    Item
    Lesion Location
    text
    C2986548 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    New Lesion Description
    Item
    New Lesion Description (Specify Exact Location)
    text
    C2986548 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    New Lesion Assessment Date
    Item
    Date of Assessment
    date
    C2986548 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    New Lesion Method of Measurement
    Item
    Method of Tumor Measurement
    text
    C2986548 (UMLS CUI [1,1])
    C1299991 (UMLS CUI [1,2])
    Item Group
    Bone Check (to follow until radiological progression)
    C0203668 (UMLS CUI-1)
    Bone Scan Hot Spot
    Item
    In case of Bone scan done, indicate the total number of Hot spots:
    float
    C0203668 (UMLS CUI [1,1])
    C0203637 (UMLS CUI [1,2])
    Item Group
    Tumor Markers - to follow until PSA progression - to be performed prior to the next study drug infusion.
    C0041365 (UMLS CUI-1)
    Tumor Markers: Assessment Date
    Item
    Date of evaluation
    date
    C0041365 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item
    Test: PSA
    text
    C0041365 (UMLS CUI [1,1])
    C0201544 (UMLS CUI [1,2])
    Tumor Markers: PSA Test
    Code List
    Test: PSA
    CL Item
    PSA (PSA)
    Tumor Markers: PSA Test Value
    Item
    PSA Test Value
    float
    C0041365 (UMLS CUI [1,1])
    C0201544 (UMLS CUI [1,2])
    C1275372 (UMLS CUI [1,3])
    Tumor Markers: PSA Test Unit
    Item
    PSA Test: Unit
    text
    C0041365 (UMLS CUI [1,1])
    C0201544 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Tumor Markers: PSA Test Lower Limit
    Item
    PSA Test: Normal Range - Lower Limit
    text
    C0041365 (UMLS CUI [1,1])
    C0201544 (UMLS CUI [1,2])
    C1518030 (UMLS CUI [1,3])
    Tumor Markers: PSA Test Upper Limit
    Item
    PSA Test: Normal Range - Upper Limit
    text
    C0041365 (UMLS CUI [1,1])
    C0201544 (UMLS CUI [1,2])
    C1519815 (UMLS CUI [1,3])
    Item Group
    Present Pain Intensity and Analgesic Questionnaire for Cancer Pain (to follow until the first documented progression).
    C0596240 (UMLS CUI-1)
    C0034394 (UMLS CUI-2)
    Cancer Pain Questionnaire: Complete
    Item
    Was the Patient questionnaire completed for this visit?
    boolean
    C0596240 (UMLS CUI [1,1])
    C0034394 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
    Item
    If NO, please specify the primary reason:
    text
    C0596240 (UMLS CUI [1,1])
    C0034394 (UMLS CUI [1,2])
    C1549995 (UMLS CUI [1,3])
    Cancer Pain Questionnaire: Primary Reason
    Code List
    If NO, please specify the primary reason:
    CL Item
    Subject is unable due to toxicity disease (Subject is unable due to toxicity disease)
    CL Item
    Failure to distribute the questionnaire (Failure to distribute the questionnaire)
    CL Item
    Patient refusal (Patient refusal)
    CL Item
    Death (Death)
    CL Item
    Patient did not wish to show up (Patient did not wish to show up)
    CL Item
    Translation not available (Translation not available)
    CL Item
    Other (Other)
    Cancer Pain Questionnaire: Primary Reason Specification
    Item
    If NO and OTHER, Specify:
    text
    C0596240 (UMLS CUI [1,1])
    C0034394 (UMLS CUI [1,2])
    C1549995 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Pain Assessment: Date
    Item
    If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Date
    date
    C1161170 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Present Pain Intensity
    Item
    If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Present Pain Intensity
    float
    C1320357 (UMLS CUI [1])
    Analgesic Score
    Item
    If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Analgesic Score
    text
    C3202977 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    Item Group
    Disease Status
    C0699749 (UMLS CUI-1)
    Item
    Disease Status (tick one box only):
    text
    C0699749 (UMLS CUI [1])
    Disease Status
    Code List
    Disease Status (tick one box only):
    CL Item
    Not evaluable (Not evaluable)
    CL Item
    Previously reported progression (Previously reported progression)
    CL Item
    No progression (No progression)
    CL Item
    Progression (please specify the assessment) (Progression (please specify the assessment))
    Item
    Disease Status: Progression - please specify the assessment:
    text
    C1335499 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    Progressive Disease: Assessment
    Code List
    Disease Status: Progression - please specify the assessment:
    CL Item
    Tumor assessment (Tumor assessment)
    CL Item
    PSA (PSA)
    CL Item
    Pain (Pain)
    Item Group
    FACT P Questionnaire (to follow until the first documented progression).
    C3641634 (UMLS CUI-1)
    FACT P Questionnaire
    Item
    Was the assessment performed at this visit?
    boolean
    C3641634 (UMLS CUI [1])
    Item
    If NO, please specify the primary reason:
    text
    C1549995 (UMLS CUI [1,1])
    C3641634 (UMLS CUI [1,2])
    FACT P Questionnaire: Primary Reason
    Code List
    If NO, please specify the primary reason:
    CL Item
    Subject is unable due to toxicity disease (Subject is unable due to toxicity disease)
    CL Item
    Failure to distribute the questionnaire (Failure to distribute the questionnaire)
    CL Item
    Patient refusal (Patient refusal)
    CL Item
    Death (Death)
    CL Item
    Patient did not wish to show up (Patient did not wish to show up)
    CL Item
    Translation not available (Translation not available)
    CL Item
    Other (Other)
    FACT P Questionnaire: Primary Reason Specification
    Item
    If OTHER, Specify:
    text
    C1549995 (UMLS CUI [1,1])
    C3641634 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    FACT P Questionnaire: Date
    Item
    If YES, Please indicate how true each statement has been for the patient during the past 7 days: Date performed
    date
    C0011008 (UMLS CUI [1,1])
    C1549995 (UMLS CUI [1,2])
    Item Group
    FACT P Questionnaire - Physical Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
    C0517226 (UMLS CUI-1)
    Item
    I have a lack of energy.
    text
    C4048330 (UMLS CUI [1])
    Lack of Energy
    Code List
    I have a lack of energy.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I have nausea.
    text
    C0027497 (UMLS CUI [1])
    Nausea
    Code List
    I have nausea.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    Because of my physical condition, I have trouble meeting the needs of my family
    text
    C4287855 (UMLS CUI [1])
    Trouble meeting needs of family
    Code List
    Because of my physical condition, I have trouble meeting the needs of my family
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I have Pain.
    text
    C0030193 (UMLS CUI [1])
    Pain
    Code List
    I have Pain.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am bothered by side effects of treatment.
    text
    C4289375 (UMLS CUI [1])
    Bothered by side effects of treatment
    Code List
    I am bothered by side effects of treatment.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I feel ill.
    text
    C0221423 (UMLS CUI [1])
    Illness
    Code List
    I feel ill.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am forced to spend time in bed.
    text
    C4289366 (UMLS CUI [1])
    Time spend in bed
    Code List
    I am forced to spend time in bed.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item Group
    FACT P Questionnaire - Social/ Family Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
    C3476515 (UMLS CUI-1)
    Item
    I feel close to my friends.
    text
    C2984048 (UMLS CUI [1])
    Feel Close to Friends
    Code List
    I feel close to my friends.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I get emotional support from my friends.
    text
    C0600015 (UMLS CUI [1,1])
    C0079382 (UMLS CUI [1,2])
    Emotional Support from friends
    Code List
    I get emotional support from my friends.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I get support from my friends.
    text
    C2984072 (UMLS CUI [1])
    Receive Support from Friends
    Code List
    I get support from my friends.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    My family has accepted my illness.
    text
    C0278069 (UMLS CUI [1,1])
    C0015576 (UMLS CUI [1,2])
    Illness acceptancy by family
    Code List
    My family has accepted my illness.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am satisfied with my family communication about my illness.
    text
    C2984054 (UMLS CUI [1])
    Satisfied with Family Communication
    Code List
    I am satisfied with my family communication about my illness.
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I feel close to my partner (or the person who is my main support).
    text
    C2984059 (UMLS CUI [1])
    Feeling close to partner
    Code List
    I feel close to my partner (or the person who is my main support).
    CL Item
    A little bit (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all (Not at all)
    CL Item
    Quite a bit (Quite a bit)
    CL Item
    Somewhat (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    (If the patient prefers not to answer to the following question, please tick for this question NOT ANSWERED.) I am satisfied with my sex life.
    text
    C2984060 (UMLS CUI [1])
    Satisfied with Sex Life
    Code List
    (If the patient prefers not to answer to the following question, please tick for this question NOT ANSWERED.) I am satisfied with my sex life.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item Group
    FACT P Questionnaire - Emotional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
    C2984554 (UMLS CUI-1)
    Item
    I feel sad.
    text
    C3536794 (UMLS CUI [1])
    Feeling sad
    Code List
    I feel sad.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am satisfied with how I am coping with my illness.
    text
    C0009967 (UMLS CUI [1])
    Coping
    Code List
    I am satisfied with how I am coping with my illness.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am losing hope in the fight against my illness.
    text
    C2984056 (UMLS CUI [1])
    Losing hope against illness
    Code List
    I am losing hope in the fight against my illness.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I feel nervous.
    text
    C0849963 (UMLS CUI [1])
    Feeling nervous
    Code List
    I feel nervous.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I worry about dying.
    text
    C2984076 (UMLS CUI [1])
    Worry About Dying
    Code List
    I worry about dying.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I worry that my condition will get worse.
    text
    C2984075 (UMLS CUI [1])
    Worry About Worsening Condition
    Code List
    I worry that my condition will get worse.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item Group
    FACT P Quesionnaire - Functional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
    C3483376 (UMLS CUI-1)
    Item
    I am able to work (include work at home).
    text
    C2984044 (UMLS CUI [1])
    Able to work
    Code List
    I am able to work (include work at home).
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    My Work (include work at home) is fulfilling.
    text
    C2984074 (UMLS CUI [1])
    Work is fulfilling
    Code List
    My Work (include work at home) is fulfilling.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am able to enjoy life.
    text
    C2984051 (UMLS CUI [1])
    Able to enjoy life
    Code List
    I am able to enjoy life.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I have accepted my illness.
    text
    C0278069 (UMLS CUI [1])
    Acceptance of illness
    Code List
    I have accepted my illness.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am sleeping well.
    text
    C0474396 (UMLS CUI [1])
    Sleeping behaviour
    Code List
    I am sleeping well.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am enjoying the things I usually do for fun.
    text
    C0178417 (UMLS CUI [1])
    Anhedonia
    Code List
    I am enjoying the things I usually do for fun.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am content with the quality of my life right now.
    text
    C0034380 (UMLS CUI [1])
    Quality of life
    Code List
    I am content with the quality of my life right now.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item Group
    FACT P Questionnaire - Additional Concerns: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
    C3482667 (UMLS CUI-1)
    Item
    I am losing weight.
    text
    C1262477 (UMLS CUI [1])
    Losing Weight
    Code List
    I am losing weight.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I have a good appetite.
    text
    C0003618 (UMLS CUI [1])
    Appetite
    Code List
    I have a good appetite.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I have aches and pains that bother me.
    text
    C3830278 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    Bothered by pain
    Code List
    I have aches and pains that bother me.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I have certain parts of my body where I experience pain.
    text
    C3641636 (UMLS CUI [1])
    Painful Body Parts
    Code List
    I have certain parts of my body where I experience pain.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    My pain keeps me from doing things I want to do.
    text
    C3641680 (UMLS CUI [1])
    Pain Keeps Me From Doing Things I Want to Do
    Code List
    My pain keeps me from doing things I want to do.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am satisfied with my present comfort level.
    text
    C0517225 (UMLS CUI [1])
    Comfort Level
    Code List
    I am satisfied with my present comfort level.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am able to feel like a man.
    text
    C3641638 (UMLS CUI [1])
    Feel like a man
    Code List
    I am able to feel like a man.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I have trouble moving my bowels.
    text
    C3641639 (UMLS CUI [1])
    Trouble Moving Bowels
    Code List
    I have trouble moving my bowels.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I have difficulty urinating.
    text
    C0241705 (UMLS CUI [1])
    Difficulty urinating
    Code List
    I have difficulty urinating.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I urinate more frequently than usual.
    text
    C2584336 (UMLS CUI [1])
    Frequency of urination
    Code List
    I urinate more frequently than usual.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    My problems with urinating limit my activities.
    text
    C3641641 (UMLS CUI [1])
    Activities Limited by Urination Problems
    Code List
    My problems with urinating limit my activities.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
    Item
    I am able to have and maintain an erection.
    text
    C0030847 (UMLS CUI [1])
    Erection
    Code List
    I am able to have and maintain an erection.
    CL Item
    A little bit  (A little bit)
    CL Item
    Not answered (Not answered)
    CL Item
    Not at all  (Not at all)
    CL Item
    Quite a bit  (Quite a bit)
    CL Item
    Somewhat  (Somewhat)
    CL Item
    Very Much (Very Much)
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