ID

21988

Description

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

Keywords

Versions (1)
  1. 5/12/17 5/12/17 -
Uploaded on

May 12, 2017

DOI

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License

Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Baseline

English

CRFs Cabazitaxel Prostate Cancer NCT01308580 Baseline

1 forms  
Visit Information
Description

Visit Information

Alias
UMLS CUI-1
C0545082
Date of Visit
Description

Date of Visit

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Date of Informed Consent
Description

Date of Informed Consent

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2985782
dd-mmm-yyyy
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0421451
dd-mmm-yyyy
Age
Description

Age

Data type

float

Measurement units
  • Years
Alias
UMLS CUI [1]
C0001779
Years
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
If Other, specify:
Description

Race Specification

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C2348235
Ethnicity
Description

Ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
Informed Consent - Pharmacokinetic
Description

Informed Consent - Pharmacokinetic

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0031328
Page Intentionally Blank
Description

Informed Consent - Pharmacokinetic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0031328
Date of Informed Consent - Pharmacokinetic
Description

Informed Consent Date - Pharmacokinetic

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2985782
UMLS CUI [1,2]
C0031328
dd-mmm-yyyy
Informed Consent - Pharmacogenomic
Description

Informed Consent - Pharmacogenomic

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C1138555
Page Intentionally Blank
Description

Informed Consent - Pharmacogenomic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1138555
Date of Informed Consent - Pharmacogenomic
Description

Informed Consent Date - Pharmacogenomic

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2985782
UMLS CUI [1,2]
C1138555
dd-mmm-yyyy
Informed Consent - Biomarker (cDNA)
Description

Informed Consent - Biomarker (cDNA)

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0005516
Page Intentionally Blank
Description

Informed Consent - Biomarker (cDNA)

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0005516
Date of Informed Consent - Biomarker (cDNA)
Description

Informed Consent Date - Biomarker (cDNA)

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2985782
UMLS CUI [1,2]
C0005516
dd-mmm-yyyy
Cancer Diagnosis
Description

Cancer Diagnosis

Alias
UMLS CUI-1
C0920688
Date of initial (histological) diagnosis
Description

Date of Diagnosis

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2316983
dd-mmm-yyyy
Location:
Description

Cancer Location

Data type

text

Alias
UMLS CUI [1]
C0872338
If Other, Specify:
Description

Cancer Location Specification

Data type

text

Alias
UMLS CUI [1,1]
C0872338
UMLS CUI [1,2]
C2348235
Histology Type
Description

Histology Type

Data type

text

Alias
UMLS CUI [1]
C1317416
If Other, Specify:
Description

Histology Type Specification

Data type

text

Alias
UMLS CUI [1,1]
C1317416
UMLS CUI [1,2]
C2348235
Gleason Score (2 - 10)
Description

Gleason Score

Data type

integer

Alias
UMLS CUI [1]
C0332326
Staging - T
Description

T - Tumor stage

Data type

text

Alias
UMLS CUI [1]
C0475455
Staging - N
Description

N Stage

Data type

text

Alias
UMLS CUI [1]
C0456532
Staging - M
Description

M - Metastasis stages

Data type

text

Alias
UMLS CUI [1]
C0456533
Status at Study Entry
Description

Status at Study Entry

Alias
UMLS CUI-1
C0018759
Extent at study entry (tick one box only):
Description

Extent of disease at study entry

Data type

text

Alias
UMLS CUI [1,1]
C0449279
UMLS CUI [1,2]
C0680254
Criteria on which progression before study entry was diagnosed (tick all that apply). If progression was diagnosed on bone scan only, please complete the next page to document the two sequential assessments with two new lesions.
Description

Progression Criteria

Data type

text

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0242801
Progression on bone scans only - two sequential assessments with two new lesions
Description

Progression on bone scans only - two sequential assessments with two new lesions

Alias
UMLS CUI-1
C0203668
Lesion Location
Description

Lesion Location

Data type

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0450429
New Lesion Description (Specifiy Exact Location)
Description

Lesion Description

Data type

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C2348235
Date of assessment
Description

Date of assessment

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2985720
dd-mmm-yyyy
Prior surgery for prostatic carcinoma excluding androgen ablation
Description

Prior surgery for prostatic carcinoma excluding androgen ablation

Alias
UMLS CUI-1
C0194790
Radical Prostatectomy - performed?
Description

Radical Prostatectomy

Data type

boolean

Alias
UMLS CUI [1]
C0194810
Radical Prostatectomy - if performed, specify surgery date.
Description

Date of Radical Prostatectomy

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C1628561
dd-mmm-yyyy
Pelvic Lymphadenectomy - performed?
Description

Pelvic Lymphadenectomy

Data type

boolean

Alias
UMLS CUI [1]
C0193883
Pelvic Lymphadenectomy - if performed, specify surgery date.
Description

Date of Pelvic Lymphadenectomy

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0193883
UMLS CUI [1,2]
C1628561
dd-mmm-yyyy
Transurethral Resection of Prostate (TURP) - performed?
Description

Transurethral Resection of Prostate

Data type

boolean

Alias
UMLS CUI [1]
C0040771
Transurethral Resection of Prostate - if performed, specify surgery date.
Description

Date of Transurethral Resection of Prostate

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0040771
UMLS CUI [1,2]
C1628561
dd-mmm-yyyy
Cryosurgery - performed?
Description

Cryosurgery

Data type

boolean

Alias
UMLS CUI [1]
C0010408
Cryosurgery - if performed, specify surgery date.
Description

Date of Cryosurgery

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0010408
UMLS CUI [1,2]
C1628561
dd-mmm-yyyy
High intensity focused ultrasound - performed?
Description

High intensity focused ultrasound

Data type

boolean

Alias
UMLS CUI [1]
C0441583
High intesity focused ultrasound - if performed, specify surgery date.
Description

Date of High intesity focused ultrasound

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0441583
dd-mmm-yyyy
Other operation on prostate?
Description

Other operation on prostate

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0194790
If other operation on prostate performed, specify surgery date.
Description

Date of other operation on prostate

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0194790
UMLS CUI [1,3]
C1628561
dd-mmm-yyyy
Prior surgery for androgen ablation
Description

Prior surgery for androgen ablation

Alias
UMLS CUI-1
C1515985
UMLS CUI-2
C0543467
Bilateral Orchiectomy - performed?
Description

Bilateral Orchiectomy

Data type

boolean

Alias
UMLS CUI [1]
C0194875
Bilateral Orchiectomy - if performed, specify surgery date.
Description

Date of Bilateral Orchiectomy

Data type

text

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0194875
UMLS CUI [1,2]
C1628561
dd-mmm-yyyy
Bilateral Adrenalectomy - performed?
Description

Bilateral Adrenalectomy

Data type

boolean

Alias
UMLS CUI [1]
C0193704
Bilateral Adrenalectomy - if performed, specify surgery date.
Description

Date of Bilateral Adrenalectomy

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0193704
UMLS CUI [1,2]
C1628561
dd-mmm-yyyy
Hypophysectomy - performed?
Description

Hypophysectomy

Data type

boolean

Alias
UMLS CUI [1]
C0020632
Hypophysectomy - if performed, specify surgery date.
Description

Date of Hypophysectomy

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0020632
UMLS CUI [1,2]
C1628561
dd-mmm-yyyy
Other Surgery for androgen ablation?
Description

Other Surgery for androgen ablation

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1515985
UMLS CUI [1,3]
C0543467
If other surgery for androgen ablation performed, specify surgery date.
Description

Date of other surgery for androgen ablation

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1515985
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C1628561
dd-mmm-yyyy
Radiation Therapy - Prior Treatment
Description

Radiation Therapy - Prior Treatment

Alias
UMLS CUI-1
C0279134
Location
Description

Site of Radiation

Data type

text

Alias
UMLS CUI [1]
C0458344
Stop Date
Description

Stop Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yyyy
Total Dose
Description

Total Dose

Data type

float

Alias
UMLS CUI [1]
C2986497
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Intent
Description

Intent of Radiation Therapy

Data type

text

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C1522449
Prior Anti-Cancer Therapy: Systemic Therapies
Description

Prior Anti-Cancer Therapy: Systemic Therapies

Alias
UMLS CUI-1
C1514457
Intent
Description

Intent of prior Chemotherapy

Data type

text

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C1514457
Reason for Discontinuation
Description

Reason for Disontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0392360
Best Response
Description

Best Response

Data type

text

Alias
UMLS CUI [1]
C2986560
Relapse/progression Date
Description

Relapse Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
Regimen No.
Description

Regimen Number

Data type

text

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0237753
Drug Per Regimen
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C0013227
Therapy Type
Description

Therapy

Data type

text

Alias
UMLS CUI [1]
C0087111
Start Date
Description

Start Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0808070
dd-mmm-yyyy
End Date
Description

End Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yyyy
Ongoing?
Description

Ongoing Regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0949219
Medical or Surgical History - Record relevant Medical/ Surgical History other than Primary Prostate Tumor cancer surgery
Description

Medical or Surgical History - Record relevant Medical/ Surgical History other than Primary Prostate Tumor cancer surgery

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0744961
Medical/ Surgery History
Description

Medical/ Surgery History

Data type

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0744961
Start Date
Description

Start Date Comorbidity

Data type

date

Measurement units
  • Month/Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0009488
Month/Year
Ongoing
Description

Ongoing Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0009488
If yes, disease/ synotins controlled:
Description

Disease controlled

Data type

boolean

Alias
UMLS CUI [1]
C0920467
Renal Medical History/ Risk - Record Renal Medical History or Concomitant Diease at Risk for Renal Failure.
Description

Renal Medical History/ Risk - Record Renal Medical History or Concomitant Diease at Risk for Renal Failure.

Alias
UMLS CUI-1
C0022658
UMLS CUI-2
C3697935
Diabetes - occured?
Description

Diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011849
If occured, specify Start Date.
Description

Diabetes Start Date

Data type

date

Measurement units
  • Month/ Year
Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0808070
Month/ Year
If occured, is it ongoing.
Description

Diabetes Ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0011849
If yes, disease/ symptoms controlled:
Description

Diabetes controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0920467
UMLS CUI [1,2]
C0011849
Renal Medical or Surgical History
Description

Renal Medical History

Data type

text

Alias
UMLS CUI [1]
C0022658
Start Date
Description

Renal Disease Start Date

Data type

date

Measurement units
  • Month/ Year
Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0808070
Month/ Year
Ongoing
Description

Renal Disease Ongoing

Data type

text

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0549178
If yes, disease/ symptoms controlled:
Description

Renal Disease Controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0920467
Medication - Renal Treatment Risk - Does the patient have such Concomitant Treatment at Risk for Renal failure?
Description

Medication - Renal Treatment Risk - Does the patient have such Concomitant Treatment at Risk for Renal failure?

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0599918
Bisphosphonates - Taken?
Description

Bisphosphonates

Data type

boolean

Alias
UMLS CUI [1]
C0012544
Antiinflammatory Agents, Non-Steroidal - Taken?
Description

Antiinflammatory Agents, Non-Steroidal

Data type

boolean

Alias
UMLS CUI [1]
C0003211
Aminoglycosides - Taken?
Description

Aminoglycosides

Data type

boolean

Alias
UMLS CUI [1]
C0002556
Vancomycin - Taken?
Description

Vancomycin

Data type

boolean

Alias
UMLS CUI [1]
C0042313
Concomitant Treatment at Risk of Renal failure?
Description

Nephrotoxic Medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0599918
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date performed
Description

Date of report

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1302584
dd-mmm-yyyy
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Body Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Description

Heart Rate

Data type

float

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Performance Status: ECOG
Description

ECOG Performance Status

Data type

integer

Alias
UMLS CUI [1]
C1520224
Ophthalmologic Examination - Report last examination done within 3 months before study entry.
Description

Ophthalmologic Examination - Report last examination done within 3 months before study entry.

Alias
UMLS CUI-1
C0200149
Date performed
Description

Date of Ophthalmologic Examination

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C1302584
dd-mmm-yyyy
Was a cataract diagnosis?
Description

Cataract

Data type

boolean

Alias
UMLS CUI [1]
C0086543
If Yes, please complete the grade (according to the NCI CTC AE V4.03).
Description

Cataract Grade

Data type

text

Alias
UMLS CUI [1]
C2025367
Electrocardiogram (12 Leads)
Description

Electrocardiogram (12 Leads)

Alias
UMLS CUI-1
C1623258
Date performed
Description

Date of Electrocardiogram

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1302584
dd-mmm-yyyy
Interpretation
Description

ECG Interpretation

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0459471
If abnormal, clinically significant?
Description

ECG abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0522055
Laboratory Tests Hematology
Description

Laboratory Tests Hematology

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

Laboratory Test Hematology Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826641
UMLS CUI [1,2]
C0474523
dd-mmm-yyyy
Hemoglobin
Description

Hemoglobin

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Platelet Count (Thromobocyte Count)
Description

Platelet Count

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0005821
10^9/L
White Blood Cell Count (Leukocyte Count)
Description

White Blood Cell Count

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0023508
10^9/L
Neutrophils
Description

Neutrophil Count

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0200633
10^9/L
Lymphocytes
Description

Lymphocytes

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0024264
10^9/L
Monocytes
Description

Monocytes

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0026473
10^9/L
Eosinophils
Description

Eosinophils

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0200638
10^9/L
Basophils
Description

Basophils

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0200641
10^9/L
International normalized Ratio (to be performed only for patient under vitamin k antagonist)
Description

INR

Data type

float

Measurement units
  • Ratio
Alias
UMLS CUI [1]
C0525032
Ratio
Laboratory Tests Biochemisty
Description

Laboratory Tests Biochemisty

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

Laboratory Test Biochemistry Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826641
UMLS CUI [1,2]
C0005477
dd-mmm-yyyy
Sodium
Description

Sodium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Potassium
Description

Potassium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202194
mmol/L
Calcium
Description

Calcium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201925
mmol/L
Phosphorus
Description

Phosphorus

Data type

boolean

Alias
UMLS CUI [1]
C0031705
Blood Urea Nitrogen
Description

Blood Urea Nitrogen

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0005845
mmol/L
Magnesium
Description

Magnesium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0373675
mmol/L
Total Proteins
Description

Total Proteins

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0555903
g/L
Albumin
Description

Albumin

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0201838
g/L
Glucose
Description

Blood Glucose

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202042
mmol/L
Testosterone
Description

Testosterone

Data type

float

Alias
UMLS CUI [1]
C0523912
AST (SGOT - ASAT)
Description

AST

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
ALT (SGoT - ASAT) Normal Ranges - Upper Limit
Description

AST Normal Range

Data type

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0086715
ALT (SGPT - ALAT)
Description

ALT

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
ALT (SGPT - ALAT) Normal Range - Upper Limit
Description

ALT Normal Range

Data type

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0086715
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Alkaline Phosphatase Normal Range - Upper Limit
Description

Alkaline Phosphatase Normal Range

Data type

text

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0086715
Total Bilirubin
Description

Total Bilirubin

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1]
C0201913
umol/L
Total Bilirubin Normal Range - Upper Limit
Description

Total Bilirubin Normal Range

Data type

text

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C0086715
Creatinine
Description

Creatinine

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1]
C0201976
umol/L
Creatinine Normal Range - Upper Limit
Description

Creatinine Normal Range

Data type

text

Alias
UMLS CUI [1]
C0201976
Lactate Dehydrogenase
Description

Lactate Dehydrogenase

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0202113
U/L
Lactate Dehydrogenase Normal Range - Upper Limit
Description

Lactate Dehydrogenase Normal Range

Data type

text

Alias
UMLS CUI [1,1]
C0202113
UMLS CUI [1,2]
C0086715
Laboratory Tests Urinanalysis
Description

Laboratory Tests Urinanalysis

Alias
UMLS CUI-1
C0042014
Date
Description

Urinanalysis Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2826641
dd-mmm-yyyy
Sodium (Urine)
Description

Urine Sodium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C1256585
mmol/L
Potassium (Urine)
Description

Urine Potassium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202195
mmol/L
Calcium (Urine)
Description

Urine Calcium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0428303
mmol/L
Cholride (Urine)
Description

Urine Chloride

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201953
mmol/L
White Blood Cell Count (Urine)
Description

Urine White Blood Cell Count

Data type

float

Measurement units
  • /mm3
Alias
UMLS CUI [1]
C0919738
/mm3
Eosinophils (Urine)
Description

Urine Eosinophils

Data type

float

Measurement units
  • /mm3
Alias
UMLS CUI [1]
C1141979
/mm3
Red Blood Cells (Urine)
Description

Urine Erythrocytes

Data type

text

Alias
UMLS CUI [1]
C1254564
Urea (Urine)
Description

Urine Urea

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0428278
mmol/L
Total Proteins (Urine)
Description

Urine Total Protein

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0428541
mg/dL
Creatinine (Urine)
Description

Urine Creatinine

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0236441
mg/dL
Circulating free plasma DNA - Blood sampling
Description

Circulating free plasma DNA - Blood sampling

Alias
UMLS CUI-1
C0005834
Date of Sample
Description

Sample ID: Z00 - Theoretical Time: Baseline Sample ID: Z01 - Theoretical Time: Baseline (at least 24h apart)

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1317250
dd-mmm-yyyy
Tumor Workup at Baseline
Description

Tumor Workup at Baseline

Alias
UMLS CUI-1
C3889740
Location: Pelvis Method of Assessment
Description

Pelvis: Method of Assessment

Data type

text

Alias
UMLS CUI [1,1]
C0030797
UMLS CUI [1,2]
C2598110
Date
Description

Pelvis: Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0030797
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2985720
dd-mmm-yyyy
Normal?
Description

Pelvis: Assessment Finding

Data type

boolean

Alias
UMLS CUI [1,1]
C0030797
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C0243095
If abnormal, specify.
Description

Pelvis: Assessment Finding Abnormal

Data type

text

Alias
UMLS CUI [1,1]
C0030797
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2826279
If abnormal and other, specify.
Description

Pelvis: Assessment Finding Abnormal Specification

Data type

text

Alias
UMLS CUI [1,1]
C0030797
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2826279
UMLS CUI [1,4]
C2348235
Location: Abdomen Method of Assessment
Description

Abdomen: Method of Assessment

Data type

text

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C2598110
Date
Description

Abdomen: Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2985720
dd-mmm-yyyy
Normal?
Description

Abdomen: Assessment Finding

Data type

boolean

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C0243095
If abnormal, specify.
Description

Abdomen: Assessment Finding Abnormal

Data type

text

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2826279
If abnormal and other, specify.
Description

Abdomen: Assessment Finding Abnormal Specification

Data type

text

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2826279
UMLS CUI [1,4]
C2348235
Location: Thorax Method of Assessment
Description

Thorax: Method of Assessment

Data type

text

Alias
UMLS CUI [1,1]
C0817096
UMLS CUI [1,2]
C2598110
Date
Description

Thorax: Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0817096
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2985720
dd-mmm-yyyy
Normal?
Description

Thorax: Assessment Finding

Data type

boolean

Alias
UMLS CUI [1,1]
C0817096
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C0243095
If abnormal, specify.
Description

Thorax: Assessment Finding Abnormal

Data type

text

Alias
UMLS CUI [1,1]
C0817096
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2826279
If abnormal and other, specify.
Description

Thorax: Assessment Finding Abnormal Specification

Data type

text

Alias
UMLS CUI [1,1]
C0817096
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2826279
UMLS CUI [1,4]
C2348235
Location: Bone Method of Assessment
Description

Bone: Method of Assessment

Data type

text

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C2598110
If other, specify.
Description

Bone: Method of Assessment Specification

Data type

text

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2348235
Date
Description

Bone: Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2985720
dd-mmm-yyyy
Normal?
Description

Bone: Assessment Finding

Data type

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C0243095
If abnormal, specify.
Description

Bone: Assessment Finding Abnormal

Data type

text

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2826279
If abnormal and other, specify.
Description

Bone: Assessment Finding Abnormal Specification

Data type

text

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2826279
UMLS CUI [1,4]
C2348235
Other Location
Description

Other Location

Data type

text

Alias
UMLS CUI [1]
C1515974
Other Location Method of Assessment
Description

Other Location: Method of Assessment

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2598110
Date
Description

Other Location: Date of Assessment

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2985720
dd-mmm-yyyy
Normal?
Description

Other Location: Assessment Finding

Data type

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C0243095
If abnormal, specify.
Description

Other Location: Assessment Finding Abnormal

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2826279
If abnormal and other, specify.
Description

Other Location: Assessment Finding Abnormal Specification

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2598110
UMLS CUI [1,3]
C2826279
UMLS CUI [1,4]
C2348235
Tumor Assessment - Recist 1.1 - Target Lesions (at Baseline)
Description

Tumor Assessment - Recist 1.1 - Target Lesions (at Baseline)

Alias
UMLS CUI-1
C3889740
UMLS CUI-2
C2986546
Lesion Number - The Lesion number should be entered in the sequential order
Description

Target Lesion Number

Data type

float

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

Target Lesion Location

Data type

text

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

Target Lesion Description

Data type

text

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

Target Lesion Date of Assessment

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C2986546
dd-mmm-yyyy
Method of Tumor Measurement
Description

Method of Target Lesion Measurement

Data type

text

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

Measurement of Target Lesion: Diameter

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C3827751
UMLS CUI [1,2]
C2986546
mm
Tumor Assessment - Recist 1.1 - Non-target Lesion (at Baseline)
Description

Tumor Assessment - Recist 1.1 - Non-target Lesion (at Baseline)

Alias
UMLS CUI-1
C3889740
UMLS CUI-2
C2986547
Lesion Location
Description

Non-target Lesion Location

Data type

text

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C2986547
Lesion Description (Subsite)
Description

Non-target Lesion Description

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C2986547
Date of Assessment
Description

Non-target Lesion Date of Assessment

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C2986547
dd-mmm-yyyy
Bone Check
Description

Bone Check

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

Bone Scan: Number of Hot Spots

Data type

float

Alias
UMLS CUI [1,1]
C0203668
UMLS CUI [1,2]
C3829661
UMLS CUI [1,3]
C0449788
Tumor markers - in case of rising PSA at study entry, record the tree or four last values to evidence the protocol definded rising PSA
Description

Tumor markers - in case of rising PSA at study entry, record the tree or four last values to evidence the protocol definded rising PSA

Alias
UMLS CUI-1
C0041365
Date of evaluation
Description

PSA measurement: Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C2985720
dd-mmm-yyyy
Value
Description

PSA measurement

Data type

float

Alias
UMLS CUI [1]
C0201544
Unit
Description

PSA measurement: Unit

Data type

text

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C1519795
Normal Range - Lower Limit
Description

PSA measurement: Lower Limit

Data type

text

Alias
UMLS CUI [1,1]
C1518030
UMLS CUI [1,2]
C0201544
Normal Range - Upper Limit
Description

PSA measurement

Data type

text

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C1519815
Present Pain Intensitiy and Analgesic Questionnaire for Cancer Pain
Description

Present Pain Intensitiy and Analgesic Questionnaire for Cancer Pain

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

Questionnaire for Cancer Pain: Completed

Data type

boolean

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

Questionnaire for Cancer Pain: Primary Reason

Data type

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0596240
UMLS CUI [1,3]
C1549995
If OTHER, Specify:
Description

Questionnaire for Cancer Pain: Primary Reason Specification

Data type

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0596240
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 Day1): DAY 01 - 07 Date
Description

Questionnaire for Cancer Pain: Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0596240
UMLS CUI [1,3]
C2985720
dd-mmm-yyyy
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day1): DAY 01 - 07 Present Pain Intensity
Description

Questionnaire for Cancer Pain: Pain Intensity

Data type

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0596240
UMLS CUI [1,3]
C3840282
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day1): DAY 01 - 07 Analgesic Score
Description

Questionnaire for Cancer Pain: Analgesic Score

Data type

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0596240
UMLS CUI [1,3]
C0002771
UMLS CUI [1,4]
C0449820
FACT-P Questionnaire
Description

FACT-P Questionnaire

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

FACT-P Questionnaire

Data type

boolean

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

FACT-P Questionnaire

Data type

text

Alias
UMLS CUI [1,1]
C3641634
UMLS CUI [1,2]
C1549995
If YES, specify Date performed.
Description

FACT-P Questionnaire Date

Data type

date

Measurement units
  • DD-MON-YYYY
Alias
UMLS CUI [1,1]
C3641634
UMLS CUI [1,2]
C2985720
DD-MON-YYYY
FACT-P Questionnaire - If YES, Please indicate how true each statement has been for the patient during the past 7 days: Physical Well-Being
Description

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

Alias
UMLS CUI-1
C3641634
UMLS CUI-2
C0517226
I have a lack of energy.
Description

Lack of Energy

Data type

text

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

Nausea

Data type

text

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

Trouble meeting needs of family

Data type

text

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

Pain

Data type

text

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

Bothered by side effects of treatment

Data type

text

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

Illness

Data type

text

Alias
UMLS CUI [1]
C0221423
I am forced to spend time in Bed.
Description

Time spent in bed

Data type

text

Alias
UMLS CUI [1]
C2135946
FACT-P Questionnaire - If YES, Please indicate how true each statement has been for the patient during the past 7 days: Social/ Family Well-Being.
Description

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

Alias
UMLS CUI-1
C3641634
UMLS CUI-2
C3476515
I feel close to my friends.
Description

Feel Close to Friends

Data type

text

Alias
UMLS CUI [1]
C2984048
I get emotional suport from my family.
Description

Emotional Support from family

Data type

text

Alias
UMLS CUI [1]
C2984050
I get support from my friends.
Description

Emotional Support from friends

Data type

text

Alias
UMLS CUI [1,1]
C0600015
UMLS CUI [1,2]
C0079382
My family has accepted my illness.
Description

Family acceptance of illnesss

Data type

text

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

Family communication about illness

Data type

text

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

Feeling close to partner

Data type

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.
Description

Satisfied with Sex Life

Data type

text

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

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

Alias
UMLS CUI-1
C3641634
UMLS CUI-2
C2984554
I feel sad.
Description

Feeling sad

Data type

text

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

Coping

Data type

text

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

Losing hope against illness

Data type

text

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

Feeling nervous

Data type

text

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

Worry About Dying

Data type

text

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

Worry About Worsening Condition

Data type

text

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

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

Alias
UMLS CUI-1
C3641634
UMLS CUI-2
C2984555
I am able to work (include work at home).
Description

Able to work

Data type

text

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

Work is fulfilling

Data type

text

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

Able to enjoy life

Data type

text

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

Acceptance of illness

Data type

text

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

Sleeping behaviour

Data type

text

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

Anhedonia

Data type

text

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

Quality of life

Data type

text

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

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

Alias
UMLS CUI-1
C3641634
UMLS CUI-2
C3482667
I am losing weight.
Description

Losing Weight

Data type

text

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

Appetite

Data type

text

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

Bothered by pain

Data type

text

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

Painful Body Parts

Data type

text

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

Pain Keeps Me From Doing Things I Want to Do

Data type

text

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

Comfort Level

Data type

text

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

Feel like a man

Data type

text

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

Bowel movement

Data type

text

Alias
UMLS CUI [1]
C0011135
I have difficulty urinating.
Description

Difficulty urinating

Data type

text

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

Frequency of urination

Data type

text

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

Activities Limited by Urination Problems

Data type

text

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

Erection

Data type

text

Alias
UMLS CUI [1]
C0030847
Eligibility for Randomization
Description

Eligibility for Randomization

Alias
UMLS CUI-1
C0013893
UMLS CUI-2
C0034656
Does the subject have one or more inclusion/ exclusion criteria not met?
Description

Inclusion or Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0680251
If YES, please specify the Inclusion criteria number(s):
Description

Inclusion Criteria Number

Data type

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0237753
If YES, please specify the exclusion criteria number(s):
Description

Exclusion Criteria Number

Data type

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0237753
will the subject continue into the randomization phase?
Description

Randomization

Data type

boolean

Alias
UMLS CUI [1]
C0034656
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Similar models

CRFs Cabazitaxel Prostate Cancer NCT01308580 Baseline

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Visit Information
C0545082 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Date of Informed Consent
Item
Date of Informed Consent
date
C2985782 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Age
Item
Age
float
C0001779 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Caucasian/ White (Caucasian/ White)
CL Item
Black (Black)
CL Item
Asian/ Oriental (Asian/ Oriental)
CL Item
Other (Other)
Race Specification
Item
If Other, specify:
text
C0034510 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic (Hispanic)
CL Item
Not hispanic (Not hispanic)
Item Group
Informed Consent - Pharmacokinetic
C0021430 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
Informed Consent - Pharmacokinetic
Item
Page Intentionally Blank
boolean
C0021430 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Informed Consent Date - Pharmacokinetic
Item
Date of Informed Consent - Pharmacokinetic
date
C2985782 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Item Group
Informed Consent - Pharmacogenomic
C0021430 (UMLS CUI-1)
C1138555 (UMLS CUI-2)
Informed Consent - Pharmacogenomic
Item
Page Intentionally Blank
boolean
C0021430 (UMLS CUI [1,1])
C1138555 (UMLS CUI [1,2])
Informed Consent Date - Pharmacogenomic
Item
Date of Informed Consent - Pharmacogenomic
date
C2985782 (UMLS CUI [1,1])
C1138555 (UMLS CUI [1,2])
Item Group
Informed Consent - Biomarker (cDNA)
C0021430 (UMLS CUI-1)
C0005516 (UMLS CUI-2)
Informed Consent - Biomarker (cDNA)
Item
Page Intentionally Blank
boolean
C0021430 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
Informed Consent Date - Biomarker (cDNA)
Item
Date of Informed Consent - Biomarker (cDNA)
date
C2985782 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
Item Group
Cancer Diagnosis
C0920688 (UMLS CUI-1)
Date of Diagnosis
Item
Date of initial (histological) diagnosis
date
C2316983 (UMLS CUI [1])
Item
Location:
text
C0872338 (UMLS CUI [1])
Cancer Location
Code List
Location:
CL Item
Prostate (Prostate)
CL Item
Other (Other)
Cancer Location Specification
Item
If Other, Specify:
text
C0872338 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Histology Type
text
C1317416 (UMLS CUI [1])
Histology Type
Code List
Histology Type
CL Item
Adenocarcinoma (Adenocarcinoma)
CL Item
Other (Other)
Histology Type Specification
Item
If Other, Specify:
text
C1317416 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Gleason Score
Item
Gleason Score (2 - 10)
integer
C0332326 (UMLS CUI [1])
T - Tumor stage
Item
Staging - T
text
C0475455 (UMLS CUI [1])
N Stage
Item
Staging - N
text
C0456532 (UMLS CUI [1])
M - Metastasis stages
Item
Staging - M
text
C0456533 (UMLS CUI [1])
Item Group
Status at Study Entry
C0018759 (UMLS CUI-1)
Item
Extent at study entry (tick one box only):
text
C0449279 (UMLS CUI [1,1])
C0680254 (UMLS CUI [1,2])
Extent of disease at study entry
Code List
Extent at study entry (tick one box only):
CL Item
Metastatic (Metastatic)
CL Item
Loco regional (Loco regional)
Item
Criteria on which progression before study entry was diagnosed (tick all that apply). If progression was diagnosed on bone scan only, please complete the next page to document the two sequential assessments with two new lesions.
text
C0242656 (UMLS CUI [1,1])
C0242801 (UMLS CUI [1,2])
Progression Criteria
Code List
Criteria on which progression before study entry was diagnosed (tick all that apply). If progression was diagnosed on bone scan only, please complete the next page to document the two sequential assessments with two new lesions.
CL Item
Rising PSA (Rising PSA)
CL Item
Progression of measurable lesions (Progression of measurable lesions)
CL Item
Progression of non-measurable lesions (except bone) (Progression of non-measurable lesions (except bone))
CL Item
Appearance of new lesions on bone scan (Appearance of new lesions on bone scan)
Item Group
Progression on bone scans only - two sequential assessments with two new lesions
C0203668 (UMLS CUI-1)
Lesion Location
Item
Lesion Location
text
C0221198 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Lesion Description
Item
New Lesion Description (Specifiy Exact Location)
text
C0221198 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item Group
Prior surgery for prostatic carcinoma excluding androgen ablation
C0194790 (UMLS CUI-1)
Radical Prostatectomy
Item
Radical Prostatectomy - performed?
boolean
C0194810 (UMLS CUI [1])
Date of Radical Prostatectomy
Item
Radical Prostatectomy - if performed, specify surgery date.
date
C0194810 (UMLS CUI [1,1])
C1628561 (UMLS CUI [1,2])
Pelvic Lymphadenectomy
Item
Pelvic Lymphadenectomy - performed?
boolean
C0193883 (UMLS CUI [1])
Date of Pelvic Lymphadenectomy
Item
Pelvic Lymphadenectomy - if performed, specify surgery date.
date
C0193883 (UMLS CUI [1,1])
C1628561 (UMLS CUI [1,2])
Transurethral Resection of Prostate
Item
Transurethral Resection of Prostate (TURP) - performed?
boolean
C0040771 (UMLS CUI [1])
Date of Transurethral Resection of Prostate
Item
Transurethral Resection of Prostate - if performed, specify surgery date.
date
C0040771 (UMLS CUI [1,1])
C1628561 (UMLS CUI [1,2])
Cryosurgery
Item
Cryosurgery - performed?
boolean
C0010408 (UMLS CUI [1])
Date of Cryosurgery
Item
Cryosurgery - if performed, specify surgery date.
date
C0010408 (UMLS CUI [1,1])
C1628561 (UMLS CUI [1,2])
High intensity focused ultrasound
Item
High intensity focused ultrasound - performed?
boolean
C0441583 (UMLS CUI [1])
Date of High intesity focused ultrasound
Item
High intesity focused ultrasound - if performed, specify surgery date.
date
C0441583 (UMLS CUI [1])
Other operation on prostate
Item
Other operation on prostate?
text
C0205394 (UMLS CUI [1,1])
C0194790 (UMLS CUI [1,2])
Date of other operation on prostate
Item
If other operation on prostate performed, specify surgery date.
date
C0205394 (UMLS CUI [1,1])
C0194790 (UMLS CUI [1,2])
C1628561 (UMLS CUI [1,3])
Item Group
Prior surgery for androgen ablation
C1515985 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
Bilateral Orchiectomy
Item
Bilateral Orchiectomy - performed?
boolean
C0194875 (UMLS CUI [1])
Date of Bilateral Orchiectomy
Item
Bilateral Orchiectomy - if performed, specify surgery date.
text
C0194875 (UMLS CUI [1,1])
C1628561 (UMLS CUI [1,2])
Bilateral Adrenalectomy
Item
Bilateral Adrenalectomy - performed?
boolean
C0193704 (UMLS CUI [1])
Date of Bilateral Adrenalectomy
Item
Bilateral Adrenalectomy - if performed, specify surgery date.
date
C0193704 (UMLS CUI [1,1])
C1628561 (UMLS CUI [1,2])
Hypophysectomy
Item
Hypophysectomy - performed?
boolean
C0020632 (UMLS CUI [1])
Date of Hypophysectomy
Item
Hypophysectomy - if performed, specify surgery date.
date
C0020632 (UMLS CUI [1,1])
C1628561 (UMLS CUI [1,2])
Other Surgery for androgen ablation
Item
Other Surgery for androgen ablation?
text
C0205394 (UMLS CUI [1,1])
C1515985 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Date of other surgery for androgen ablation
Item
If other surgery for androgen ablation performed, specify surgery date.
date
C0205394 (UMLS CUI [1,1])
C1515985 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C1628561 (UMLS CUI [1,4])
Item Group
Radiation Therapy - Prior Treatment
C0279134 (UMLS CUI-1)
Site of Radiation
Item
Location
text
C0458344 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Total Dose
Item
Total Dose
float
C2986497 (UMLS CUI [1])
Item
Unit
text
C1519795 (UMLS CUI [1])
Unit
Code List
Unit
CL Item
Grays (Grays)
CL Item
Rads (Rads)
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Intent of Radiation Therapy
Code List
Intent
CL Item
Palliative (Palliative)
CL Item
Curative (Curative)
Item Group
Prior Anti-Cancer Therapy: Systemic Therapies
C1514457 (UMLS CUI-1)
Intent of prior Chemotherapy
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
Reason for Disontinuation
Item
Reason for Discontinuation
text
C0457454 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Best Response
Item
Best Response
text
C2986560 (UMLS CUI [1])
Relapse Date
Item
Relapse/progression Date
date
C0035020 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Regimen Number
Item
Regimen No.
text
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Drug Name
Item
Drug Per Regimen
text
C0013227 (UMLS CUI [1])
Therapy
Item
Therapy Type
text
C0087111 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Ongoing Regimen
Item
Ongoing?
boolean
C0549178 (UMLS CUI [1,1])
C0949219 (UMLS CUI [1,2])
Item Group
Medical or Surgical History - Record relevant Medical/ Surgical History other than Primary Prostate Tumor cancer surgery
C0262926 (UMLS CUI-1)
C0744961 (UMLS CUI-3)
Medical/ Surgery History
Item
Medical/ Surgery History
text
C0262926 (UMLS CUI [1])
C0744961 (UMLS CUI [2])
Start Date Comorbidity
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Ongoing Comorbidity
Item
Ongoing
boolean
C0549178 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Disease controlled
Item
If yes, disease/ synotins controlled:
boolean
C0920467 (UMLS CUI [1])
Item Group
Renal Medical History/ Risk - Record Renal Medical History or Concomitant Diease at Risk for Renal Failure.
C0022658 (UMLS CUI-1)
C3697935 (UMLS CUI-2)
Diabetes
Item
Diabetes - occured?
boolean
C0011849 (UMLS CUI [1])
Diabetes Start Date
Item
If occured, specify Start Date.
date
C0011849 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Diabetes Ongoing
Item
If occured, is it ongoing.
boolean
C0549178 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Diabetes controlled
Item
If yes, disease/ symptoms controlled:
boolean
C0920467 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Renal Medical History
Item
Renal Medical or Surgical History
text
C0022658 (UMLS CUI [1])
Renal Disease Start Date
Item
Start Date
date
C0022658 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Renal Disease Ongoing
Item
Ongoing
text
C0022658 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Renal Disease Controlled
Item
If yes, disease/ symptoms controlled:
boolean
C0022658 (UMLS CUI [1,1])
C0920467 (UMLS CUI [1,2])
Item Group
Medication - Renal Treatment Risk - Does the patient have such Concomitant Treatment at Risk for Renal failure?
C0013227 (UMLS CUI-1)
C0599918 (UMLS CUI-2)
Bisphosphonates
Item
Bisphosphonates - Taken?
boolean
C0012544 (UMLS CUI [1])
Antiinflammatory Agents, Non-Steroidal
Item
Antiinflammatory Agents, Non-Steroidal - Taken?
boolean
C0003211 (UMLS CUI [1])
Aminoglycosides
Item
Aminoglycosides - Taken?
boolean
C0002556 (UMLS CUI [1])
Vancomycin
Item
Vancomycin - Taken?
boolean
C0042313 (UMLS CUI [1])
Nephrotoxic Medication
Item
Concomitant Treatment at Risk of Renal failure?
text
C0013227 (UMLS CUI [1,1])
C0599918 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date of report
Item
Date performed
date
C1302584 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Height
Item
Height
float
C0005890 (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 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item Group
Ophthalmologic Examination - Report last examination done within 3 months before study entry.
C0200149 (UMLS CUI-1)
Date of Ophthalmologic Examination
Item
Date performed
date
C0200149 (UMLS CUI [1,1])
C1302584 (UMLS CUI [1,2])
Cataract
Item
Was a cataract diagnosis?
boolean
C0086543 (UMLS CUI [1])
Cataract Grade
Item
If Yes, please complete the grade (according to the NCI CTC AE V4.03).
text
C2025367 (UMLS CUI [1])
Item Group
Electrocardiogram (12 Leads)
C1623258 (UMLS CUI-1)
Date of Electrocardiogram
Item
Date performed
date
C1623258 (UMLS CUI [1,1])
C1302584 (UMLS CUI [1,2])
Item
Interpretation
text
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
ECG Interpretation
Code List
Interpretation
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
ECG abnormal
Item
If abnormal, clinically significant?
boolean
C0522055 (UMLS CUI [1])
Item Group
Laboratory Tests Hematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Laboratory Test Hematology Date
Item
Date
date
C2826641 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Platelet Count
Item
Platelet Count (Thromobocyte Count)
float
C0005821 (UMLS CUI [1])
White Blood Cell Count
Item
White Blood Cell Count (Leukocyte Count)
float
C0023508 (UMLS CUI [1])
Neutrophil Count
Item
Neutrophils
float
C0200633 (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])
INR
Item
International normalized Ratio (to be performed only for patient under vitamin k antagonist)
float
C0525032 (UMLS CUI [1])
Item Group
Laboratory Tests Biochemisty
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
boolean
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])
Testosterone
Item
Testosterone
float
C0523912 (UMLS CUI [1])
AST
Item
AST (SGOT - ASAT)
float
C0201899 (UMLS CUI [1])
AST Normal Range
Item
ALT (SGoT - ASAT) Normal Ranges - Upper Limit
text
C0201899 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT - ALAT)
float
C0201836 (UMLS CUI [1])
ALT Normal Range
Item
ALT (SGPT - ALAT) Normal Range - Upper Limit
text
C0201836 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline Phosphatase Normal Range
Item
Alkaline Phosphatase Normal Range - Upper Limit
text
C0201850 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Total Bilirubin Normal Range
Item
Total Bilirubin Normal Range - Upper Limit
text
C0201913 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Creatinine Normal Range
Item
Creatinine Normal Range - Upper Limit
text
C0201976 (UMLS CUI [1])
Lactate Dehydrogenase
Item
Lactate Dehydrogenase
float
C0202113 (UMLS CUI [1])
Lactate Dehydrogenase Normal Range
Item
Lactate Dehydrogenase Normal Range - Upper Limit
text
C0202113 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Item Group
Laboratory Tests Urinanalysis
C0042014 (UMLS CUI-1)
Urinanalysis Date
Item
Date
date
C0042014 (UMLS CUI [1,1])
C2826641 (UMLS CUI [1,2])
Urine Sodium
Item
Sodium (Urine)
float
C1256585 (UMLS CUI [1])
Urine Potassium
Item
Potassium (Urine)
float
C0202195 (UMLS CUI [1])
Urine Calcium
Item
Calcium (Urine)
float
C0428303 (UMLS CUI [1])
Urine Chloride
Item
Cholride (Urine)
float
C0201953 (UMLS CUI [1])
Urine White Blood Cell Count
Item
White Blood Cell Count (Urine)
float
C0919738 (UMLS CUI [1])
Urine Eosinophils
Item
Eosinophils (Urine)
float
C1141979 (UMLS CUI [1])
Urine Erythrocytes
Item
Red Blood Cells (Urine)
text
C1254564 (UMLS CUI [1])
Urine Urea
Item
Urea (Urine)
float
C0428278 (UMLS CUI [1])
Urine Total Protein
Item
Total Proteins (Urine)
float
C0428541 (UMLS CUI [1])
Urine Creatinine
Item
Creatinine (Urine)
float
C0236441 (UMLS CUI [1])
Item Group
Circulating free plasma DNA - Blood sampling
C0005834 (UMLS CUI-1)
Date of Sample
Item
Date of Sample
date
C1317250 (UMLS CUI [1])
Item Group
Tumor Workup at Baseline
C3889740 (UMLS CUI-1)
Pelvis: Method of Assessment
Item
Location: Pelvis Method of Assessment
text
C0030797 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
Pelvis: Assessment Date
Item
Date
date
C0030797 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Pelvis: Assessment Finding
Item
Normal?
boolean
C0030797 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If abnormal, specify.
text
C0030797 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
Pelvis: Assessment Abnormal Finding
Code List
If abnormal, specify.
CL Item
Tumor Related (Tumor Related)
CL Item
Other (Other)
Pelvis: Assessment Finding Abnormal Specification
Item
If abnormal and other, specify.
text
C0030797 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Abdomen: Method of Assessment
Item
Location: Abdomen Method of Assessment
text
C0000726 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
Abdomen: Assessment Date
Item
Date
date
C0000726 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Abdomen: Assessment Finding
Item
Normal?
boolean
C0000726 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If abnormal, specify.
text
C0000726 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
Abdomen: Assessment Finding Abnormal
Code List
If abnormal, specify.
CL Item
Tumor related (Tumor related)
CL Item
Other (Other)
Abdomen: Assessment Finding Abnormal Specification
Item
If abnormal and other, specify.
text
C0000726 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Thorax: Method of Assessment
Item
Location: Thorax Method of Assessment
text
C0817096 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
Thorax: Assessment Date
Item
Date
date
C0817096 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Thorax: Assessment Finding
Item
Normal?
boolean
C0817096 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If abnormal, specify.
text
C0817096 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
Thorax: Assessment Finding Abnormal
Code List
If abnormal, specify.
CL Item
Tumor related (Tumor related)
CL Item
Other (Other)
Thorax: Assessment Finding Abnormal Specification
Item
If abnormal and other, specify.
text
C0817096 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Location: Bone Method of Assessment
text
C0262950 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
Bone: Method of Assessment
Code List
Location: Bone Method of Assessment
CL Item
Bone Scan (Bone Scan)
CL Item
Other (Other)
Bone: Method of Assessment Specification
Item
If other, specify.
text
C0262950 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Bone: Assessment Date
Item
Date
date
C0262950 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Bone: Assessment Finding
Item
Normal?
boolean
C0262950 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If abnormal, specify.
text
C0262950 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
Bone: Assessment Finding Abnormal
Code List
If abnormal, specify.
CL Item
Tumor related (Tumor related)
CL Item
Other (Other)
Bone: Assessment Finding Abnormal Specification
Item
If abnormal and other, specify.
text
C0262950 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Other Location
Item
Other Location
text
C1515974 (UMLS CUI [1])
Other Location: Method of Assessment
Item
Other Location Method of Assessment
text
C1515974 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
Other Location: Date of Assessment
Item
Date
date
C1515974 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Other Location: Assessment Finding
Item
Normal?
boolean
C1515974 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If abnormal, specify.
text
C1515974 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
Other Location: Assessment Finding Abnormal
Code List
If abnormal, specify.
CL Item
Tumor related (Tumor related)
CL Item
Other (Other)
Other Location: Assessment Finding Abnormal Specification
Item
If abnormal and other, specify.
text
C1515974 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Tumor Assessment - Recist 1.1 - Target Lesions (at Baseline)
C3889740 (UMLS CUI-1)
C2986546 (UMLS CUI-2)
Target Lesion Number
Item
Lesion Number - The Lesion number should be entered in the sequential order
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 Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
Method of Target Lesion Measurement
Item
Method of Tumor Measurement
text
C1299991 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
Measurement of Target Lesion: Diameter
Item
Measurement of Target Lesion: Diameter
float
C3827751 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
Item Group
Tumor Assessment - Recist 1.1 - Non-target Lesion (at Baseline)
C3889740 (UMLS CUI-1)
C2986547 (UMLS CUI-2)
Non-target Lesion Location
Item
Lesion Location
text
C0450429 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
Non-target Lesion Description
Item
Lesion Description (Subsite)
text
C0678257 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
Non-target Lesion Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
Item Group
Bone Check
C0203668 (UMLS CUI-1)
Bone Scan: Number of Hot Spots
Item
In case of Bone scan done, indicate the total number of Hot spots:
float
C0203668 (UMLS CUI [1,1])
C3829661 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Item Group
Tumor markers - in case of rising PSA at study entry, record the tree or four last values to evidence the protocol definded rising PSA
C0041365 (UMLS CUI-1)
PSA measurement: Assessment Date
Item
Date of evaluation
date
C0201544 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
PSA measurement
Item
Value
float
C0201544 (UMLS CUI [1])
PSA measurement: Unit
Item
Unit
text
C0201544 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
PSA measurement: Lower Limit
Item
Normal Range - Lower Limit
text
C1518030 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
PSA measurement
Item
Normal Range - Upper Limit
text
C0201544 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Item Group
Present Pain Intensitiy and Analgesic Questionnaire for Cancer Pain
C0034394 (UMLS CUI-1)
C0596240 (UMLS CUI-2)
Questionnaire for Cancer Pain: Completed
Item
Was the Patient questionnaire completed for this visit?
boolean
C0034394 (UMLS CUI [1,1])
C0596240 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Item
If NO, please specify the primary reason:
text
C0034394 (UMLS CUI [1,1])
C0596240 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
Questionnaire for Cancer Pain 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)
Questionnaire for Cancer Pain: Primary Reason Specification
Item
If OTHER, Specify:
text
C0034394 (UMLS CUI [1,1])
C0596240 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Questionnaire for Cancer Pain: Assessment Date
Item
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day1): DAY 01 - 07 Date
date
C0034394 (UMLS CUI [1,1])
C0596240 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Questionnaire for Cancer Pain: Pain Intensity
Item
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day1): DAY 01 - 07 Present Pain Intensity
text
C0034394 (UMLS CUI [1,1])
C0596240 (UMLS CUI [1,2])
C3840282 (UMLS CUI [1,3])
Questionnaire for Cancer Pain: Analgesic Score
Item
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day1): DAY 01 - 07 Analgesic Score
text
C0034394 (UMLS CUI [1,1])
C0596240 (UMLS CUI [1,2])
C0002771 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
Item Group
FACT-P Questionnaire
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
C3641634 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
FACT-P Questionnaire
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 Date
Item
If YES, specify Date performed.
date
C3641634 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
FACT-P Questionnaire - If YES, Please indicate how true each statement has been for the patient during the past 7 days: Physical Well-Being
C3641634 (UMLS CUI-1)
C0517226 (UMLS CUI-2)
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
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
Item
I have nausea.
text
C0027497 (UMLS CUI [1])
Nausea
Code List
I have nausea.
CL Item
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
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
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
Item
I have Pain.
text
C0030193 (UMLS CUI [1])
Pain
Code List
I have Pain.
CL Item
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
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
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
Item
I feel ill.
text
C0221423 (UMLS CUI [1])
Illness
Code List
I feel ill.
CL Item
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
Item
I am forced to spend time in Bed.
text
C2135946 (UMLS CUI [1])
Time spent in bed
Code List
I am forced to spend time in Bed.
CL Item
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
Item Group
FACT-P Questionnaire - If YES, Please indicate how true each statement has been for the patient during the past 7 days: Social/ Family Well-Being.
C3641634 (UMLS CUI-1)
C3476515 (UMLS CUI-2)
Item
I feel close to my friends.
text
C2984048 (UMLS CUI [1])
undefined item
Code List
I feel close to my friends.
CL Item
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
Item
I get emotional suport from my family.
text
C2984050 (UMLS CUI [1])
undefined item
Code List
I get emotional suport from my family.
CL Item
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
Item
I get support from my friends.
text
C0600015 (UMLS CUI [1,1])
C0079382 (UMLS CUI [1,2])
undefined item
Code List
I get support from my friends.
CL Item
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
Item
My family has accepted my illness.
text
C0278069 (UMLS CUI [1,1])
C0015576 (UMLS CUI [1,2])
undefined item
Code List
My family has accepted my illness.
CL Item
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
Item
I am satisfied with family communication about my illness.
text
C2984054 (UMLS CUI [1])
undefined item
Code List
I am satisfied with family communication about my illness.
CL Item
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
Item
I feel close to my partner (or the person who is my main support).
text
C2984059 (UMLS CUI [1])
undefined item
Code List
I feel close to my partner (or the person who is my main support).
CL Item
Not at all (Not at all)
CL Item
A little bit (A little bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a bit (Quite a bit)
CL Item
Very Much (Very Much)
CL Item
Not answered (Not answered)
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
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item Group
FACT-P Questionnaire - If YES, Please indicate how true each statement has been for the patient during the past 7 days: Emotional Well-Being.
C3641634 (UMLS CUI-1)
C2984554 (UMLS CUI-2)
Item
I feel sad.
text
C3536794 (UMLS CUI [1])
Feeling sad
Code List
I feel sad.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I am satisfied with how I am coping with my illness.
text
C0009967 (UMLS CUI [1])
undefined item
Code List
I am satisfied with how I am coping with my illness.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I am losing hope in the fight against my illness.
text
C2984056 (UMLS CUI [1])
undefined item
Code List
I am losing hope in the fight against my illness.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I feel nervous.
text
C0849963 (UMLS CUI [1])
undefined item
Code List
I feel nervous.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I worry about dying.
text
C2984076 (UMLS CUI [1])
undefined item
Code List
I worry about dying.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I worry that my condition will get worse.
text
C2984075 (UMLS CUI [1])
undefined item
Code List
I worry that my condition will get worse.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item Group
FACT-P Questionnaire - If YES, Please indicate how true each statement has been for the patient during the past 7 days: Functional Well-Being.
C3641634 (UMLS CUI-1)
C2984555 (UMLS CUI-2)
Item
I am able to work (include work at home).
text
C2984044 (UMLS CUI [1])
undefined item
Code List
I am able to work (include work at home).
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
My Work (include work at home) is fulfilling.
text
C2984074 (UMLS CUI [1])
undefined item
Code List
My Work (include work at home) is fulfilling.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I am able to enjoy life.
text
C2984051 (UMLS CUI [1])
undefined item
Code List
I am able to enjoy life.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I have accepted my illness.
text
C0278069 (UMLS CUI [1])
undefined item
Code List
I have accepted my illness.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I am sleeping well.
text
C0474396 (UMLS CUI [1])
undefined item
Code List
I am sleeping well.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I am enjoying the things I usually do for fun.
text
C0178417 (UMLS CUI [1])
undefined item
Code List
I am enjoying the things I usually do for fun.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I am content with the quality of my life right now.
text
C0034380 (UMLS CUI [1])
undefined item
Code List
I am content with the quality of my life right now.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item Group
FACT-P Questionnaire - If YES, Please indicate how true each statement has been for the patient during the past 7 days: Additional Concerns.
C3641634 (UMLS CUI-1)
C3482667 (UMLS CUI-2)
Item
I am losing weight.
text
C1262477 (UMLS CUI [1])
undefined item
Code List
I am losing weight.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I have a good appetite.
text
C0003618 (UMLS CUI [1])
undefined item
Code List
I have a good appetite.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I have aches and pains that bother me.
text
C3830278 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
undefined item
Code List
I have aches and pains that bother me.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I have certain parts of my body where I experience pain.
text
C3641636 (UMLS CUI [1])
undefined item
Code List
I have certain parts of my body where I experience pain.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
My pain keeps me from doing things I want to do.
text
C3641680 (UMLS CUI [1])
undefined item
Code List
My pain keeps me from doing things I want to do.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I am satisfied with my present comfort level.
text
C0517225 (UMLS CUI [1])
undefined item
Code List
I am satisfied with my present comfort level.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I am able to feel like a man.
text
C3641638 (UMLS CUI [1])
undefined item
Code List
I am able to feel like a man.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I have trouble moving my bowels.
text
C0011135 (UMLS CUI [1])
undefined item
Code List
I have trouble moving my bowels.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I have difficulty urinating.
text
C0241705 (UMLS CUI [1])
undefined item
Code List
I have difficulty urinating.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I urinate more frequently than usual.
text
C2584336 (UMLS CUI [1])
undefined item
Code List
I urinate more frequently than usual.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
My problems with urinating limit my activities.
text
C3641641 (UMLS CUI [1])
undefined item
Code List
My problems with urinating limit my activities.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item
I am able to have and maintain an erection.
text
C0030847 (UMLS CUI [1])
undefined item
Code List
I am able to have and maintain an erection.
CL Item
Not at all  (Not at all)
CL Item
A little bit  (A little bit)
CL Item
Somewhat  (Somewhat)
CL Item
Quite a bit  (Quite a bit)
CL Item
Very Much  (Very Much)
CL Item
Not answered (Not answered)
Item Group
Eligibility for Randomization
C0013893 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Inclusion or Exclusion Criteria
Item
Does the subject have one or more inclusion/ exclusion criteria not met?
boolean
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Inclusion Criteria Number
Item
If YES, please specify the Inclusion criteria number(s):
text
C1512693 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Exclusion Criteria Number
Item
If YES, please specify the exclusion criteria number(s):
text
C0680251 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomization
Item
will the subject continue into the randomization phase?
boolean
C0034656 (UMLS CUI [1])
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