Information:
Fel:
ID
22902
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)
- 2017-06-15 2017-06-15 -
Uppladdad den
15 juni 2017
DOI
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Licens
Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Additional
CRFs Cabazitaxel Prostate Cancer NCT01308580 Additional
- StudyEvent: ODM
Similar models
CRFs Cabazitaxel Prostate Cancer NCT01308580 Additional
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Laboratory Tests Hematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
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)
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
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])
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])
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])
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])
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])
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])
C1519815 (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])
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])
CL Item
PSA (PSA)
Tumor Markers: Assessment Date
Item
Date of evaluation
date
C0041365 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
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])
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])
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])
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])
C0201544 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
Item Group
Laboratory Tests Unplanned
C0022885 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C3854240 (UMLS CUI-2)
Unplanned Laboratory Test Date
Item
Date
date
C2826641 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,2])
Unplanned Laboratory Test
Item
Test
text
C0022885 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
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])
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])
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])
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])
C3854240 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
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])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
ECG Date
Item
Date performed:
date
C2826640 (UMLS CUI [1])
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])
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])
C0430370 (UMLS CUI [1,2])
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])
C0430370 (UMLS CUI [1,2])
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])
C0430370 (UMLS CUI [1,2])
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])
C0430370 (UMLS CUI [1,2])
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])
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])
C2348235 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,3])
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)
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])
Radiation Therapy: Location
Item
Location
text
C1515974 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
Radiation Therapy: Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
Radtiation Therapy: Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
Radiation Therapy: Total Dose
Item
Total Dose
float
C2986497 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
CL Item
Grays (Grays)
CL Item
Rads (Rads)
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])
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])
C0920425 (UMLS CUI [1,2])
Anti-Cancer Therapy: End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,2])
Anti-Cancer Therapy: Ongoing
Item
Ongoing
boolean
C0549178 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
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])
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])
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])
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])
C0085415 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Renal Failure Investigation
C0035078 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
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])
C0035078 (UMLS CUI [1,2])
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])
C0035078 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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])
C0010702 (UMLS CUI [1,2])
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])
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])
C4086879 (UMLS CUI [1,2])
Date of Last Information
Item
Date of last available information*:
date
C0011008 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,2])
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])
C2348235 (UMLS CUI [1,2])
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])
C2348235 (UMLS CUI [1,2])