ID

22902

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. 6/15/17 6/15/17 -
Uploaded on

June 15, 2017

DOI

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License

Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Additional

English

CRFs Cabazitaxel Prostate Cancer NCT01308580 Additional

1 forms  
Laboratory Tests Hematology
Description

Laboratory Tests Hematology

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

Laboratory Test Date

Data type

date

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

Hemoglobin

Data type

float

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

Platelets

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

Neutrophils

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0948762
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
Laboratory Tests Biochemistry
Description

Laboratory Tests Biochemistry

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

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0031705
mmol/L
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
AST (SGOT - ASAT)
Description

AST

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
AST (SGOT - ASAT): Normal Range - Upper Limit
Description

AST: Upper Limit

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519815
U/L
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: Upper Limit

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519815
U/L
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: Upper Limit

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C1519815
U/L
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: Upper Limit

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
umol/L
Creatinine
Description

Creatinine

Data type

float

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

Creatinine: Upper Limit

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519815
umol/L
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: Upper Limit

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1,1]
C0202113
UMLS CUI [1,2]
C1519815
U/L
Laboratory Tests Urinanalysis
Description

Laboratory Tests Urinanalysis

Alias
UMLS CUI-1
C0042014
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

Macroscopic Hematuria

Data type

float

Measurement units
  • /mm3
Alias
UMLS CUI [1]
C0473237
/mm3
Urea (Urine)
Description

Urine Urea

Data type

float

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

Proteinuria

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0033687
mg/dL
Creatinine (Urine)
Description

Urine Creatinine

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0236441
mg/dL
Tumor Markers - to follow until PSA progression
Description

Tumor Markers - to follow until PSA progression

Alias
UMLS CUI-1
C0041365
Test: PSA
Description

Tumor Markers: PSA Test

Data type

text

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C0201544
Date of evaluation
Description

Tumor Markers: Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C2985720
dd-mmm-yyyy
PSA Test Value
Description

Tumor Markers: PSA Test Value

Data type

float

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

Tumor Markers: PSA Test Unit

Data type

text

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

Tumor Markers: PSA Test Lower Limit

Data type

text

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

Tumor Markers: PSA Test Upper Limit

Data type

text

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C0201544
UMLS CUI [1,3]
C1519815
Laboratory Tests Unplanned
Description

Laboratory Tests Unplanned

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C3854240
Date
Description

Unplanned Laboratory Test Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826641
UMLS CUI [1,2]
C3854240
dd-mmm-yyyy
Test
Description

Unplanned Laboratory Test

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C3854240
Value
Description

Unplanned Laboratory Test Value

Data type

float

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C3854240
UMLS CUI [1,3]
C1522609
Unit
Description

Unplanned Laboratory Test Unit

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C3854240
UMLS CUI [1,3]
C1519795
Unplanned Laboratory Test: Normal Range - Lower Limit
Description

Unplanned Laboratory Test Lower Limit

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C3854240
UMLS CUI [1,3]
C1518030
Unplanned Laboratory Test: Normal Range - Upper Limit
Description

Unplanned Laboratory Test Upper Limit

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C3854240
UMLS CUI [1,3]
C1519815
Vital Signs (Additional)
Description

Vital Signs (Additional)

Alias
UMLS CUI-1
C0518766
Date performed:
Description

Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2985720
dd-mmm-yyyy
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood Pressure: Systolic
Description

Systolic Blood Pressure

Data type

float

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

Body Temperature

Data type

float

Measurement units
  • Celsius
Alias
UMLS CUI [1]
C0005903
Celsius
Performance Status: ECOG
Description

ECOG Performance Status

Data type

integer

Alias
UMLS CUI [1]
C1520224
Electrocardiogram (12 Lead) (Additional)
Description

Electrocardiogram (12 Lead) (Additional)

Alias
UMLS CUI-1
C0013798
Date performed:
Description

ECG Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2826640
dd-mmm-yyyy
Interpretation
Description

ECG finding

Data type

text

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

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C2826279
Dipstick Urinanalysis - Complete this page only if microscopic urinanalysis is not possible.
Description

Dipstick Urinanalysis - Complete this page only if microscopic urinanalysis is not possible.

Alias
UMLS CUI-1
C0430370
Date of sampling
Description

Collection date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1317250
dd-mmm-yyyy
White Blood Cells (qualitative)
Description

Urine Dipstick: White Blood Cells

Data type

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0430370
Red Blood Cells (qualitative)
Description

Urine Dipstick: Red Blood Cells

Data type

text

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C0430370
Proteins (qualitative)
Description

Urine Dipstick: Proteins

Data type

text

Alias
UMLS CUI [1,1]
C0033684
UMLS CUI [1,2]
C0430370
Glucose (qualitiatve)
Description

Urine Dipstick: Glucose

Data type

text

Alias
UMLS CUI [1,1]
C0017725
UMLS CUI [1,2]
C0430370
Other Urine Dipstick Test
Description

Urine Dipstick: Other

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0430370
Result of other Urine Dipstick Test:
Description

Urine Dipstick: Other Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0430370
Medication - Prior and Concomitant (Record all medications that the subject has taken within 21 days prior randomization and any medication taken during study)
Description

Medication - Prior and Concomitant (Record all medications that the subject has taken within 21 days prior randomization and any medication taken during study)

Alias
UMLS CUI-1
C2826257
UMLS CUI-3
C2347852
Drug/Medication (Brand or generic name)
Description

Medication

Data type

text

Alias
UMLS CUI [1]
C0013227
Reason
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

Medication Start Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C3173309
dd-mmm-yyyy
End Date
Description

Medication End Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2826744
dd-mmm-yyyy
OR Ongoing
Description

Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Radiation Therapy: Concomitant - Post Treatment
Description

Radiation Therapy: Concomitant - Post Treatment

Alias
UMLS CUI-1
C1522449
Location
Description

Radiation Therapy: Location

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C1522449
Start Date
Description

Radiation Therapy: Start Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1522449
dd-mmm-yyyy
Stop Date
Description

Radtiation Therapy: Stop Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1522449
dd-mmm-yyyy
Total Dose
Description

Radiation Therapy: Total Dose

Data type

float

Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C1522449
Unit
Description

Radiation Therapy: Unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C1522449
Intent
Description

Radiation Therapy: Intention

Data type

text

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

Anti-Cancer Therapy: Concomitant - Post Systemic Therapies

Alias
UMLS CUI-1
C0920425
Regimen No.
Description

Regimen Number

Data type

float

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

Chemotherapy Regimen

Data type

text

Alias
UMLS CUI [1]
C0392920
Previously Reported
Description

Previously Reported

Data type

boolean

Alias
UMLS CUI [1]
C0205309
Therapy Type
Description

Therapy Type

Data type

text

Alias
UMLS CUI [1]
C0087111
Anti-Cancer Therapy: Start Date
Description

Anti-Cancer Therapy: Start Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0920425
dd-mmm-yyyy
End Date
Description

Anti-Cancer Therapy: End Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0920425
dd-mmm-yyyy
Ongoing
Description

Anti-Cancer Therapy: Ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0920425
Surgery for Prostate Cancer: Concomitant - Post Treatment (Record relevant surgery information)
Description

Surgery for Prostate Cancer: Concomitant - Post Treatment (Record relevant surgery information)

Alias
UMLS CUI-1
C0194790
Surgery
Description

Operation on prostate

Data type

text

Alias
UMLS CUI [1]
C0194790
Surgery Date
Description

Date of operation on prostate

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0194790
UMLS CUI [1,2]
C3258210
dd-mmm-yyyy
Other Procedures - Only for additional procedures related or performed as a result of an adverse event or for additional procedures not planned in the protocol but of interest to support safety analysis in the protocol.)
Description

Other Procedures - Only for additional procedures related or performed as a result of an adverse event or for additional procedures not planned in the protocol but of interest to support safety analysis in the protocol.)

Alias
UMLS CUI-1
C0393107
Procedure Description
Description

Procedure Description

Data type

text

Alias
UMLS CUI [1]
C0807506
Procedure Date
Description

Procedure Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2584899
dd-mmm-yyyy
Outcome
Description

Outcome

Data type

text

Alias
UMLS CUI [1]
C0085415
If abnormal, Clinical significant?
Description

Abnormal Outcome

Data type

boolean

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C0085415
If YES, Specify:
Description

Abnormal Outcome Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C0085415
UMLS CUI [1,3]
C2348235
Renal Failure Investigation
Description

Renal Failure Investigation

Alias
UMLS CUI-1
C0035078
UMLS CUI-2
C0220825
Procedure Description: Nephrological Examination - performed
Description

Nephrological Examination

Data type

boolean

Alias
UMLS CUI [1]
C1696488
Procedure Description: Kidney Biopsy - Performed?
Description

Kidney Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0194073
Procedure Date
Description

Renal Failure: Procedure Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2584899
UMLS CUI [1,2]
C0035078
dd-mmm-yyyy
Outcome
Description

Renal Failure: Outcome

Data type

text

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C0035078
If Abnormal, Specify:
Description

Renal Failure: Outcome Specification

Data type

text

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C0035078
UMLS CUI [1,3]
C2348235
Procedures - Cystoscopy
Description

Procedures - Cystoscopy

Alias
UMLS CUI-1
C0010702
Procedure Description: Cystoscopy - Performed?
Description

Cystoscopy

Data type

boolean

Alias
UMLS CUI [1]
C0010702
Procedure Description: Bladder Biopsy - Performed?
Description

Bladder Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0194379
Procedure Date
Description

Cystoscopy: Procedure Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2584899
UMLS CUI [1,2]
C0010702
dd-mmm-yyyy
Outcome
Description

Cystoscopy: Outcome

Data type

text

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C0010702
If Abnormal, Specify:
Description

Specification

Data type

text

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C0010702
UMLS CUI [1,3]
C2348235
Symptomatic Deterioration (To be filled in only in case of symptomatic deterioration without documented objective progression on tumor assessment, PSA and/or pain as defined in the protocol.)
Description

Symptomatic Deterioration (To be filled in only in case of symptomatic deterioration without documented objective progression on tumor assessment, PSA and/or pain as defined in the protocol.)

Alias
UMLS CUI-1
C4086879
Date
Description

Symptomatic Deterioration: Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C4086879
dd-mmm-yyyy
Subject Status
Description

Subject Status

Alias
UMLS CUI-1
C3891295
Date of last available information*:
Description

*In case of failing to recontact the patient, please use the information from the last actual contact for date of last available information.

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1533716
dd-mmm-yyyy
Method of contact:
Description

Method of Contact

Data type

text

Alias
UMLS CUI [1]
C1997600
If Other, Specify:
Description

Method of Contact Specification

Data type

text

Alias
UMLS CUI [1,1]
C1997600
UMLS CUI [1,2]
C2348235
Subject Status
Description

*In case of failing to recontact the patient, please use the information from the last actual contact for date of last available information. **If the patient died, please complete a DEATH report form

Data type

text

Alias
UMLS CUI [1]
C3891295
Consent withdrawn
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
If ticked, specify reason:
Description

Informed Consent Specification

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2348235
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Similar models

CRFs Cabazitaxel Prostate Cancer NCT01308580 Additional

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Laboratory Tests Hematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Laboratory Test Date
Item
Date
date
C2826641 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Platelets
Item
Platelet Count (Thrombocyte Count)
float
C0005821 (UMLS CUI [1])
White Blood Cell Count
Item
White Blood Cell Count (Leukocyte Count)
float
C0023508 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0948762 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0024264 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Item Group
Laboratory Tests Biochemistry
C0022885 (UMLS CUI-1)
C0005477 (UMLS CUI-2)
Laboratory Test Biochemistry Date
Item
Date
date
C2826641 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Phosphorus
Item
Phosphorus
float
C0031705 (UMLS CUI [1])
Blood Urea Nitrogen
Item
Blood urea nitrogen
float
C0005845 (UMLS CUI [1])
Magnesium
Item
Magnesium
float
C0373675 (UMLS CUI [1])
Total Proteins
Item
Total Proteins
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Blood Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
AST
Item
AST (SGOT - ASAT)
float
C0201899 (UMLS CUI [1])
AST: Upper Limit
Item
AST (SGOT - ASAT): Normal Range - Upper Limit
float
C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT - ALAT)
float
C0201836 (UMLS CUI [1])
ALT: Upper Limit
Item
ALT (SGPT - ALAT): Normal Range - Upper Limit
float
C0201836 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline Phosphatase: Upper Limit
Item
Alkaline Phosphatase: Normal Range - Upper Limit
float
C0201850 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Total Bilirubin: Upper Limit
Item
Total Bilirubin: Normal Range - Upper Limit
float
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Creatinine: Upper Limit
Item
Creatinine: Normal Range - Upper Limit
float
C0201976 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Lactate Dehydrogenase
Item
Lactate Dehydrogenase
float
C0202113 (UMLS CUI [1])
Lactate Dehydrogenase: Upper Limit
Item
Lactate Dehydrogenase: Normal Range - Upper Limit
float
C0202113 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Item Group
Laboratory Tests Urinanalysis
C0042014 (UMLS CUI-1)
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])
Macroscopic Hematuria
Item
Red Blood Cells (Urine)
float
C0473237 (UMLS CUI [1])
Urine Urea
Item
Urea (Urine)
float
C0428278 (UMLS CUI [1])
Proteinuria
Item
Total Proteins (Urine)
float
C0033687 (UMLS CUI [1])
Urine Creatinine
Item
Creatinine (Urine)
float
C0236441 (UMLS CUI [1])
Item Group
Tumor Markers - to follow until PSA progression
C0041365 (UMLS CUI-1)
Item
Test: PSA
text
C0041365 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
Tumor Markers: PSA Test
Code List
Test: PSA
CL Item
PSA (PSA)
Tumor Markers: Assessment Date
Item
Date of evaluation
date
C0041365 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Tumor Markers: PSA Test Value
Item
PSA Test Value
float
C0041365 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C1275372 (UMLS CUI [1,3])
Tumor Markers: PSA Test Unit
Item
PSA Test: Unit
text
C0041365 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Tumor Markers: PSA Test Lower Limit
Item
PSA Test: Normal Range - Lower Limit
text
C0041365 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C1518030 (UMLS CUI [1,3])
Tumor Markers: PSA Test Upper Limit
Item
PSA Test: Normal Range - Upper Limit
text
C0041365 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
Item Group
Laboratory Tests Unplanned
C0022885 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Unplanned Laboratory Test Date
Item
Date
date
C2826641 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Unplanned Laboratory Test
Item
Test
text
C0022885 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Unplanned Laboratory Test Value
Item
Value
float
C0022885 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Unplanned Laboratory Test Unit
Item
Unit
text
C0022885 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Unplanned Laboratory Test Lower Limit
Item
Unplanned Laboratory Test: Normal Range - Lower Limit
text
C0022885 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C1518030 (UMLS CUI [1,3])
Unplanned Laboratory Test Upper Limit
Item
Unplanned Laboratory Test: Normal Range - Upper Limit
text
C0022885 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
Item Group
Vital Signs (Additional)
C0518766 (UMLS CUI-1)
Assessment Date
Item
Date performed:
date
C2985720 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Blood Pressure: Systolic
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood Pressure: Diastolic
float
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart rate
float
C0018810 (UMLS CUI [1])
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Performance Status: ECOG
integer
C1520224 (UMLS CUI [1])
ECOG Performance Status
Code List
Performance Status: ECOG
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Item Group
Electrocardiogram (12 Lead) (Additional)
C0013798 (UMLS CUI-1)
ECG Date
Item
Date performed:
date
C2826640 (UMLS CUI [1])
Item
Interpretation
text
C0438154 (UMLS CUI [1])
ECG finding
Code List
Interpretation
CL Item
Abnormal (Abnormal)
CL Item
Normal (Normal)
ECG finding abnormal
Item
Interpretation - If abnormal, clinically significant?
boolean
C0438154 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
Item Group
Dipstick Urinanalysis - Complete this page only if microscopic urinanalysis is not possible.
C0430370 (UMLS CUI-1)
Collection date
Item
Date of sampling
date
C1317250 (UMLS CUI [1])
Item
White Blood Cells (qualitative)
text
C0023508 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urine Dipstick: White Blood Cells
Code List
White Blood Cells (qualitative)
CL Item
Absent (Absent)
CL Item
+ (+)
CL Item
++ (++)
CL Item
+++ (+++)
CL Item
Not evalubale (Not evalubale)
CL Item
Not done (Not done)
Item
Red Blood Cells (qualitative)
text
C0014772 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
undefined item
Code List
Red Blood Cells (qualitative)
CL Item
Absent (Absent)
CL Item
+ (+)
CL Item
++ (++)
CL Item
+++ (+++)
CL Item
Not evalubale (Not evalubale)
CL Item
Not done (Not done)
Item
Proteins (qualitative)
text
C0033684 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
undefined item
Code List
Proteins (qualitative)
CL Item
Absent (Absent)
CL Item
+ (+)
CL Item
++ (++)
CL Item
+++ (+++)
CL Item
Not evalubale (Not evalubale)
CL Item
Not done (Not done)
Item
Glucose (qualitiatve)
text
C0017725 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
undefined item
Code List
Glucose (qualitiatve)
CL Item
Absent (Absent)
CL Item
+ (+)
CL Item
++ (++)
CL Item
+++ (+++)
CL Item
Not evalubale (Not evalubale)
CL Item
Not done (Not done)
Urine Dipstick: Other
Item
Other Urine Dipstick Test
text
C0205394 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Item
Result of other Urine Dipstick Test:
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,3])
undefined item
Code List
Result of other Urine Dipstick Test:
CL Item
Absent (Absent)
CL Item
+ (+)
CL Item
++ (++)
CL Item
+++ (+++)
CL Item
Not evalubale (Not evalubale)
CL Item
Not done (Not done)
Item Group
Medication - Prior and Concomitant (Record all medications that the subject has taken within 21 days prior randomization and any medication taken during study)
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
Medication
Item
Drug/Medication (Brand or generic name)
text
C0013227 (UMLS CUI [1])
Indication
Item
Reason
text
C3146298 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Medication Start Date
Item
Start Date
date
C3173309 (UMLS CUI [1])
Medication End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Medication Ongoing
Item
OR Ongoing
boolean
C2826666 (UMLS CUI [1])
Item Group
Radiation Therapy: Concomitant - Post Treatment
C1522449 (UMLS CUI-1)
Radiation Therapy: Location
Item
Location
text
C1515974 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Radiation Therapy: Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Radtiation Therapy: Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Radiation Therapy: Total Dose
Item
Total Dose
float
C2986497 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Radiation Therapy: 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])
Radiation Therapy: Intention
Code List
Intent
CL Item
Palliative (Palliative)
CL Item
Curative (Curative)
Item Group
Anti-Cancer Therapy: Concomitant - Post Systemic Therapies
C0920425 (UMLS CUI-1)
Regimen Number
Item
Regimen No.
float
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Chemotherapy Regimen
Item
Drug Per Regimen
text
C0392920 (UMLS CUI [1])
Previously Reported
Item
Previously Reported
boolean
C0205309 (UMLS CUI [1])
Therapy Type
Item
Therapy Type
text
C0087111 (UMLS CUI [1])
Anti-Cancer Therapy: Start Date
Item
date
C0808070 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Anti-Cancer Therapy: End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Anti-Cancer Therapy: Ongoing
Item
Ongoing
boolean
C0549178 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Item Group
Surgery for Prostate Cancer: Concomitant - Post Treatment (Record relevant surgery information)
C0194790 (UMLS CUI-1)
Operation on prostate
Item
Surgery
text
C0194790 (UMLS CUI [1])
Date of operation on prostate
Item
Surgery Date
date
C0194790 (UMLS CUI [1,1])
C3258210 (UMLS CUI [1,2])
Item Group
Other Procedures - Only for additional procedures related or performed as a result of an adverse event or for additional procedures not planned in the protocol but of interest to support safety analysis in the protocol.)
C0393107 (UMLS CUI-1)
Procedure Description
Item
Procedure Description
text
C0807506 (UMLS CUI [1])
Procedure Date
Item
Procedure Date
date
C2584899 (UMLS CUI [1])
Item
Outcome
text
C0085415 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Not applicable (Not applicable)
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abnormal Outcome
Item
If abnormal, Clinical significant?
boolean
C0205161 (UMLS CUI [1,1])
C0085415 (UMLS CUI [1,2])
Abnormal Outcome Specification
Item
If YES, Specify:
text
C0205161 (UMLS CUI [1,1])
C0085415 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Renal Failure Investigation
C0035078 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Nephrological Examination
Item
Procedure Description: Nephrological Examination - performed
boolean
C1696488 (UMLS CUI [1])
Kidney Biopsy
Item
Procedure Description: Kidney Biopsy - Performed?
boolean
C0194073 (UMLS CUI [1])
Renal Failure: Procedure Date
Item
Procedure Date
date
C2584899 (UMLS CUI [1,1])
C0035078 (UMLS CUI [1,2])
Item
Outcome
text
C0085565 (UMLS CUI [1,1])
C0035078 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Renal Failure: Outcome Specification
Item
If Abnormal, Specify:
text
C0085565 (UMLS CUI [1,1])
C0035078 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Procedures - Cystoscopy
C0010702 (UMLS CUI-1)
Cystoscopy
Item
Procedure Description: Cystoscopy - Performed?
boolean
C0010702 (UMLS CUI [1])
Bladder Biopsy
Item
Procedure Description: Bladder Biopsy - Performed?
boolean
C0194379 (UMLS CUI [1])
Cystoscopy: Procedure Date
Item
Procedure Date
date
C2584899 (UMLS CUI [1,1])
C0010702 (UMLS CUI [1,2])
Item
Outcome
text
C0085565 (UMLS CUI [1,1])
C0010702 (UMLS CUI [1,2])
Cystoscopy: Outcome
Code List
Outcome
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Specification
Item
If Abnormal, Specify:
text
C0085565 (UMLS CUI [1,1])
C0010702 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Symptomatic Deterioration (To be filled in only in case of symptomatic deterioration without documented objective progression on tumor assessment, PSA and/or pain as defined in the protocol.)
C4086879 (UMLS CUI-1)
Symptomatic Deterioration: Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C4086879 (UMLS CUI [1,2])
Item Group
Subject Status
C3891295 (UMLS CUI-1)
Date of Last Information
Item
Date of last available information*:
date
C0011008 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
Item
Method of contact:
text
C1997600 (UMLS CUI [1])
Method of Contact
Code List
Method of contact:
CL Item
Scheduled Visit (Scheduled Visit)
CL Item
Phone (Phone)
CL Item
Other (Other)
Method of Contact Specification
Item
If Other, Specify:
text
C1997600 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Subject Status
text
C3891295 (UMLS CUI [1])
Subject Status
Code List
Subject Status
CL Item
Alive  (Alive )
CL Item
Lost to follow-up* (Lost to follow-up*)
CL Item
Dead** (Dead**)
Informed Consent
Item
Consent withdrawn
boolean
C0021430 (UMLS CUI [1])
Informed Consent Specification
Item
If ticked, specify reason:
text
C0021430 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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