Information:
Fel:
ID
21988
Beskrivning
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
Länk
https://clinicaltrials.gov/ct2/show/NCT01308580
Nyckelord
Versioner (1)
- 2017-05-12 2017-05-12 -
Uppladdad den
12 maj 2017
DOI
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Licens
Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Baseline
CRFs Cabazitaxel Prostate Cancer NCT01308580 Baseline
- StudyEvent: ODM
Similar models
CRFs Cabazitaxel Prostate Cancer NCT01308580 Baseline
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Date of Informed Consent
Item
Date of Informed Consent
date
C2985782 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Age
Item
Age
float
C0001779 (UMLS CUI [1])
CL Item
Male (Male)
CL Item
Female (Female)
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])
C2348235 (UMLS CUI [1,2])
CL Item
Hispanic (Hispanic)
CL Item
Not hispanic (Not hispanic)
Item Group
Informed Consent - Pharmacokinetic
C0021430 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
C0031328 (UMLS CUI-2)
Informed Consent - Pharmacokinetic
Item
Page Intentionally Blank
boolean
C0021430 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
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])
C0031328 (UMLS CUI [1,2])
Item Group
Informed Consent - Pharmacogenomic
C0021430 (UMLS CUI-1)
C1138555 (UMLS CUI-2)
C1138555 (UMLS CUI-2)
Informed Consent - Pharmacogenomic
Item
Page Intentionally Blank
boolean
C0021430 (UMLS CUI [1,1])
C1138555 (UMLS CUI [1,2])
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])
C1138555 (UMLS CUI [1,2])
Item Group
Informed Consent - Biomarker (cDNA)
C0021430 (UMLS CUI-1)
C0005516 (UMLS CUI-2)
C0005516 (UMLS CUI-2)
Informed Consent - Biomarker (cDNA)
Item
Page Intentionally Blank
boolean
C0021430 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
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])
C0005516 (UMLS CUI [1,2])
Date of Diagnosis
Item
Date of initial (histological) diagnosis
date
C2316983 (UMLS CUI [1])
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])
C2348235 (UMLS CUI [1,2])
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])
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
Extent at study entry (tick one box only):
text
C0449279 (UMLS CUI [1,1])
C0680254 (UMLS CUI [1,2])
C0680254 (UMLS CUI [1,2])
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])
C0242801 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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)
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])
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])
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])
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])
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])
C1515985 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C1628561 (UMLS CUI [1,4])
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])
CL Item
Grays (Grays)
CL Item
Rads (Rads)
CL Item
Palliative (Palliative)
CL Item
Curative (Curative)
Intent of prior Chemotherapy
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C1514457 (UMLS CUI [1,2])
Reason for Disontinuation
Item
Reason for Discontinuation
text
C0457454 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
Regimen Number
Item
Regimen No.
text
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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])
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)
C0744961 (UMLS CUI-3)
Medical/ Surgery History
Item
Medical/ Surgery History
text
C0262926 (UMLS CUI [1])
C0744961 (UMLS CUI [2])
C0744961 (UMLS CUI [2])
Start Date Comorbidity
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
Ongoing Comorbidity
Item
Ongoing
boolean
C0549178 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
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)
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])
C0808070 (UMLS CUI [1,2])
Diabetes Ongoing
Item
If occured, is it ongoing.
boolean
C0549178 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,2])
Diabetes controlled
Item
If yes, disease/ symptoms controlled:
boolean
C0920467 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
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])
C0808070 (UMLS CUI [1,2])
Renal Disease Ongoing
Item
Ongoing
text
C0022658 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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])
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)
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])
C0599918 (UMLS CUI [1,2])
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])
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])
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])
Date of Electrocardiogram
Item
Date performed
date
C1623258 (UMLS CUI [1,1])
C1302584 (UMLS CUI [1,2])
C1302584 (UMLS CUI [1,2])
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)
C0474523 (UMLS CUI-2)
Laboratory Test Hematology Date
Item
Date
date
C2826641 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
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)
C0005477 (UMLS CUI-2)
Laboratory Test Biochemistry Date
Item
Date
date
C2826641 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
C0086715 (UMLS CUI [1,2])
Urinanalysis Date
Item
Date
date
C0042014 (UMLS CUI [1,1])
C2826641 (UMLS CUI [1,2])
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])
Date of Sample
Item
Date of Sample
date
C1317250 (UMLS CUI [1])
Pelvis: Method of Assessment
Item
Location: Pelvis Method of Assessment
text
C0030797 (UMLS CUI [1,1])
C2598110 (UMLS CUI [1,2])
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])
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])
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])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
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])
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])
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])
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])
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])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
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])
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])
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])
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])
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])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
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])
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])
C2598110 (UMLS CUI [1,2])
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])
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])
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])
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])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
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])
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])
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])
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])
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])
C2598110 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,3])
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])
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)
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])
C2986546 (UMLS CUI [1,2])
Target Lesion Location
Item
Lesion Location
text
C0450429 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,2])
Target Lesion Description
Item
Lesion Description (Subsite)
text
C0678257 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
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])
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])
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])
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)
C2986547 (UMLS CUI-2)
Non-target Lesion Location
Item
Lesion Location
text
C0450429 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
C2986547 (UMLS CUI [1,2])
Non-target Lesion Description
Item
Lesion Description (Subsite)
text
C0678257 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
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])
C2986547 (UMLS CUI [1,2])
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])
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])
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])
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])
C0201544 (UMLS CUI [1,2])
PSA measurement
Item
Normal Range - Upper Limit
text
C0201544 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
Item Group
Present Pain Intensitiy and Analgesic Questionnaire for Cancer Pain
C0034394 (UMLS CUI-1)
C0596240 (UMLS CUI-2)
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])
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])
C0596240 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
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])
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])
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])
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])
C0596240 (UMLS CUI [1,2])
C0002771 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
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])
C1549995 (UMLS CUI [1,2])
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])
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)
C0517226 (UMLS CUI-2)
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)
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])
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)
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])
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)
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)
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)
C3476515 (UMLS CUI-2)
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])
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])
C0079382 (UMLS CUI [1,2])
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])
C0015576 (UMLS CUI [1,2])
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])
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])
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])
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)
C2984554 (UMLS CUI-2)
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)
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])
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)
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)
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])
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)
C2984555 (UMLS CUI-2)
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)
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)
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)
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)
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)
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])
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)
C3482667 (UMLS CUI-2)
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)
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])
C0030193 (UMLS CUI [1,2])
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])
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])
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)
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)
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)
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)
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)
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])
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)
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)
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])
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])
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])
C0237753 (UMLS CUI [1,2])
Randomization
Item
will the subject continue into the randomization phase?
boolean
C0034656 (UMLS CUI [1])