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])
Item
Race
text
C0034510 (UMLS CUI [1])
CL Item
Caucasian/ White (Caucasian/ White)
CL Item
Asian/ Oriental (Asian/ Oriental)
Race Specification
Item
If Other, specify:
text
C0034510 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
CL Item
Hispanic (Hispanic)
CL Item
Not hispanic (Not hispanic)
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])
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])
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])
Date of Diagnosis
Item
Date of initial (histological) diagnosis
date
C2316983 (UMLS CUI [1])
Item
Location:
text
C0872338 (UMLS CUI [1])
CL Item
Prostate (Prostate)
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])
CL Item
Adenocarcinoma (Adenocarcinoma)
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
Extent at study entry (tick one box only):
text
C0449279 (UMLS CUI [1,1])
C0680254 (UMLS CUI [1,2])
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])
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)
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])
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])
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])
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])
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
CL Item
Abnormal (Abnormal)
ECG abnormal
Item
If abnormal, clinically significant?
boolean
C0522055 (UMLS CUI [1])
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])
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])
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])
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])
Code List
If abnormal, specify.
CL Item
Tumor Related (Tumor Related)
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])
Code List
If abnormal, specify.
CL Item
Tumor related (Tumor related)
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])
Code List
If abnormal, specify.
CL Item
Tumor related (Tumor related)
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])
Code List
Location: Bone Method of Assessment
CL Item
Bone Scan (Bone Scan)
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])
Code List
If abnormal, specify.
CL Item
Tumor related (Tumor related)
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])
Code List
If abnormal, specify.
CL Item
Tumor related (Tumor related)
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])
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])
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])
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])
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])
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])
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
Patient did not wish to show up (Patient did not wish to show up)
CL Item
Translation not available (Translation not available)
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])
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])
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
Patient did not wish to show up (Patient did not wish to show up)
CL Item
Translation not available (Translation not available)
FACT-P Questionnaire Date
Item
If YES, specify Date performed.
date
C3641634 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
I have a lack of energy.
text
C4048330 (UMLS CUI [1])
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])
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)
Item
I have Pain.
text
C0030193 (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 am bothered by side effects of treatment.
text
C4289375 (UMLS CUI [1])
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])
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])
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
I feel close to my friends.
text
C2984048 (UMLS CUI [1])
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])
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])
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])
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])
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])
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])
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
I feel sad.
text
C3536794 (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 am satisfied with how I am coping with my illness.
text
C0009967 (UMLS CUI [1])
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])
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])
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])
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])
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
I am able to work (include work at home).
text
C2984044 (UMLS CUI [1])
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])
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])
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])
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])
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])
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])
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
I am losing weight.
text
C1262477 (UMLS CUI [1])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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)
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])