ID
22855
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
Lien
https://clinicaltrials.gov/ct2/show/NCT01308580
Mots-clés
Versions (1)
- 13/06/2017 13/06/2017 -
Téléchargé le
13 juin 2017
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Follow-Up 9
CRFs Cabazitaxel Prostate Cancer NCT01308580 Follow-Up 9
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Assessment Date
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C2985720
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
ECOG Performance Status
Type de données
integer
Alias
- UMLS CUI [1]
- C1520224
Description
Tumor Assessment - Recist 1.1 (to follow until radiological progression) - Target Lesion (Previously identified). Note: If new lesion appears, please report it on the specific page "Tumor assessment (new lesion)".
Alias
- UMLS CUI-1
- C3889740
- UMLS CUI-2
- C2986546
Description
Target Lesion Number
Type de données
float
Alias
- UMLS CUI [1,1]
- C0449791
- UMLS CUI [1,2]
- C2986546
Description
Target Lesion Location
Type de données
text
Alias
- UMLS CUI [1,1]
- C0450429
- UMLS CUI [1,2]
- C2986546
Description
Target Lesion Description
Type de données
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C2986546
Description
Target Lesion Assessment Date
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2986546
- UMLS CUI [1,2]
- C2985720
Description
Target Lesion Method of Measurement
Type de données
text
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C2986546
Description
Target Lesion Diameter
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C2986546
- UMLS CUI [1,2]
- C1301886
Description
Tumor Assessment - Recist 1.1 (to follow until radiological progression) - Non-Target Lesion (Previously identified). Overall Response of Non-Target Lesions. Note: If new lesion appears, please report it on the specific page "Tumor assessment (new lesion)".
Alias
- UMLS CUI-1
- C3889740
- UMLS CUI-2
- C2986547
Description
Non-Target Lesion Assessment Date
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C2986547
Description
Overall Response of Non-Target Lesion
Type de données
text
Alias
- UMLS CUI [1,1]
- C3272903
- UMLS CUI [1,2]
- C2986547
Description
Overall Response of Non-Target Lesion Specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C3272903
- UMLS CUI [1,2]
- C2986547
- UMLS CUI [1,3]
- C2348235
Description
Non-Target Lesion Progressive Disease Location
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986547
- UMLS CUI [1,2]
- C1335499
- UMLS CUI [1,3]
- C0450429
Description
Tumor Assessment - New Lesion
Alias
- UMLS CUI-1
- C3889740
- UMLS CUI-2
- C2986548
Description
New Lesion Location
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986548
- UMLS CUI [1,2]
- C0450429
Description
New Lesion Description
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986548
- UMLS CUI [1,2]
- C0678257
Description
New Lesion Assessment Date
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2986548
- UMLS CUI [1,2]
- C2985720
Description
New Lesion Method of Measurement
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986548
- UMLS CUI [1,2]
- C1299991
Description
Bone Check (to follow until radiological progression)
Alias
- UMLS CUI-1
- C0203668
Description
Tumor Markers - to follow until PSA progression.
Alias
- UMLS CUI-1
- C0041365
Description
Tumor Markers: PSA Test
Type de données
text
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C0201544
Description
Tumor Markers: Assessment Date
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C2985720
Description
Tumor Markers: PSA Test Value
Type de données
float
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C0201544
- UMLS CUI [1,3]
- C1275372
Description
Tumor Markers: PSA Test Unit
Type de données
text
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C0201544
- UMLS CUI [1,3]
- C1519795
Description
Tumor Markers: PSA Test Lower Limit
Type de données
text
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C0201544
- UMLS CUI [1,3]
- C1518030
Description
Tumor Markers: PSA Test Upper Limit
Type de données
text
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C0201544
- UMLS CUI [1,3]
- C1519815
Description
Present Pain Intensity and Analgesic Questionnaire for Cancer Pain (to follow until the first documented progression).
Alias
- UMLS CUI-1
- C0596240
- UMLS CUI-2
- C0034394
Description
Cancer Pain Questionnaire: Complete
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0596240
- UMLS CUI [1,2]
- C0034394
- UMLS CUI [1,3]
- C0205197
Description
Cancer Pain Questionnaire: Primary Reason
Type de données
text
Alias
- UMLS CUI [1,1]
- C0596240
- UMLS CUI [1,2]
- C0034394
- UMLS CUI [1,3]
- C1549995
Description
Cancer Pain Questionnaire: Primary Reason Specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C0596240
- UMLS CUI [1,2]
- C0034394
- UMLS CUI [1,3]
- C1549995
- UMLS CUI [1,4]
- C2348235
Description
Note: Repeat on Day 01, 02, 03, 04, 05, 06, 07.
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C1161170
- UMLS CUI [1,2]
- C2985720
Description
Note: Repeat on Day 01, 02, 03, 04, 05, 06, 07.
Type de données
float
Alias
- UMLS CUI [1]
- C1320357
Description
Note: Repeat on Day 01, 02, 03, 04, 05, 06, 07.
Type de données
text
Alias
- UMLS CUI [1,1]
- C3202977
- UMLS CUI [1,2]
- C0449820
Description
Disease Status
Alias
- UMLS CUI-1
- C0699749
Description
FACT P Questionnaire (to follow until the first documented progression).
Description
FACT P Questionnaire
Type de données
boolean
Alias
- UMLS CUI [1]
- C3641634
Description
FACT P Questionnaire: Primary Reason
Type de données
text
Alias
- UMLS CUI [1,1]
- C1549995
- UMLS CUI [1,2]
- C3641634
Description
FACT P Questionnaire: Primary Reason Specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C1549995
- UMLS CUI [1,2]
- C3641634
- UMLS CUI [1,3]
- C2348235
Description
FACT P Questionnaire: Date
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1549995
Description
FACT P Questionnaire - Physical Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
Alias
- UMLS CUI-1
- C0517226
Description
Lack of Energy
Type de données
text
Alias
- UMLS CUI [1]
- C4048330
Description
Nausea
Type de données
text
Alias
- UMLS CUI [1]
- C0027497
Description
Trouble meeting needs of family
Type de données
text
Alias
- UMLS CUI [1]
- C4287855
Description
Pain
Type de données
text
Alias
- UMLS CUI [1]
- C0030193
Description
Bothered by side effects of treatment
Type de données
text
Alias
- UMLS CUI [1]
- C4289375
Description
Illness
Type de données
text
Alias
- UMLS CUI [1]
- C0221423
Description
Time spend in bed
Type de données
text
Alias
- UMLS CUI [1]
- C4289366
Description
FACT P Questionnaire - Social/ Family Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
Alias
- UMLS CUI-1
- C3476515
Description
Feel Close to Friends
Type de données
text
Alias
- UMLS CUI [1]
- C2984048
Description
Emotional Support from family
Type de données
text
Alias
- UMLS CUI [1]
- C2984050
Description
Receive Support from Friends
Type de données
text
Alias
- UMLS CUI [1]
- C2984072
Description
Illness acceptancy by family
Type de données
text
Alias
- UMLS CUI [1,1]
- C0278069
- UMLS CUI [1,2]
- C0015576
Description
Satisfied with Family Communication
Type de données
text
Alias
- UMLS CUI [1]
- C2984054
Description
Feeling close to partner
Type de données
text
Alias
- UMLS CUI [1]
- C2984059
Description
Satisfied with Sex Life
Type de données
text
Alias
- UMLS CUI [1]
- C2984060
Description
FACT P Questionnaire - Emotional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
Alias
- UMLS CUI-1
- C2984554
Description
Feeling sad
Type de données
text
Alias
- UMLS CUI [1]
- C3536794
Description
Coping
Type de données
text
Alias
- UMLS CUI [1]
- C0009967
Description
Losing hope against illness
Type de données
text
Alias
- UMLS CUI [1]
- C2984056
Description
Feeling nervous
Type de données
text
Alias
- UMLS CUI [1]
- C0849963
Description
Worry About Dying
Type de données
text
Alias
- UMLS CUI [1]
- C2984076
Description
Worry About Worsening Condition
Type de données
text
Alias
- UMLS CUI [1]
- C2984075
Description
FACT P Quesionnaire - Functional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
Alias
- UMLS CUI-1
- C3483376
Description
Able to work
Type de données
text
Alias
- UMLS CUI [1]
- C2984044
Description
Work is fulfilling
Type de données
text
Alias
- UMLS CUI [1]
- C2984074
Description
Able to enjoy life
Type de données
text
Alias
- UMLS CUI [1]
- C2984051
Description
Acceptance of illness
Type de données
text
Alias
- UMLS CUI [1]
- C0278069
Description
Sleeping behaviour
Type de données
text
Alias
- UMLS CUI [1]
- C0474396
Description
Anhedonia
Type de données
text
Alias
- UMLS CUI [1]
- C0178417
Description
Quality of life
Type de données
text
Alias
- UMLS CUI [1]
- C0034380
Description
Questionnaire - Additional Concerns FACT P Questionnaire - Additional Concerns: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
Alias
- UMLS CUI-1
- C3482667
Description
Losing Weight
Type de données
text
Alias
- UMLS CUI [1]
- C1262477
Description
Appetite
Type de données
text
Alias
- UMLS CUI [1]
- C0003618
Description
Bothered by pain
Type de données
text
Alias
- UMLS CUI [1,1]
- C3830278
- UMLS CUI [1,2]
- C0030193
Description
Painful Body Parts
Type de données
text
Alias
- UMLS CUI [1]
- C3641636
Description
Pain Keeps Me From Doing Things I Want to Do
Type de données
text
Alias
- UMLS CUI [1]
- C3641680
Description
Comfort Level
Type de données
text
Alias
- UMLS CUI [1]
- C0517225
Description
Feel like a man
Type de données
text
Alias
- UMLS CUI [1]
- C3641638
Description
Trouble Moving Bowels
Type de données
text
Alias
- UMLS CUI [1]
- C3641639
Description
Difficulty urinating
Type de données
text
Alias
- UMLS CUI [1]
- C0241705
Description
Frequency of urination
Type de données
text
Alias
- UMLS CUI [1]
- C2584336
Description
Activities Limited by Urination Problems
Type de données
text
Alias
- UMLS CUI [1]
- C3641641
Description
Erection
Type de données
text
Alias
- UMLS CUI [1]
- C0030847
Similar models
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- StudyEvent: ODM
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C2985720 (UMLS CUI [1,2])
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C2348235 (UMLS CUI [1,3])
C1335499 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
C2986548 (UMLS CUI-2)
C0450429 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,2])
C0203637 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
C0201544 (UMLS CUI [1,2])
C1275372 (UMLS CUI [1,3])
C0201544 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0201544 (UMLS CUI [1,2])
C1518030 (UMLS CUI [1,3])
C0201544 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
C0034394 (UMLS CUI-2)
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0034394 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
C0034394 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C2985720 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
C3641634 (UMLS CUI [1,2])
C3641634 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,2])
C0015576 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])