Information:
Fel:
ID
22853
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)
- 2017-06-13 2017-06-13 -
Uppladdad den
13 juni 2017
DOI
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Licens
Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Follow-Up 7
CRFs Cabazitaxel Prostate Cancer NCT01308580 Follow-Up 7
- StudyEvent: ODM
Similar models
CRFs Cabazitaxel Prostate Cancer NCT01308580 Follow-Up 7
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Date of Visit
Item
Date of Visit:
date
C1320303 (UMLS CUI [1])
Assessment Date
Item
Date performed:
date
C2985720 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Item Group
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)".
C3889740 (UMLS CUI-1)
C2986546 (UMLS CUI-2)
C2986546 (UMLS CUI-2)
Target Lesion Number
Item
Lesion Number - The Lesion number should be entered and saved to display `Lesion location` and `Lesion Description (Subsite). The lesion number entered should be similar to the lesion number from `Target Lesion (at Baseline)`.
float
C0449791 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,2])
Target Lesion Location
Item
Lesion Location
text
C0450429 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,2])
Target Lesion Description
Item
Lesion Description (Subsite)
text
C0678257 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,2])
Target Lesion Assessment Date
Item
Date of Assessment
date
C2986546 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Target Lesion Method of Measurement
Item
Method of Tumor Measurement
text
C1299991 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,2])
Target Lesion Diameter
Item
Measurement of Target Lesion: Diameter
float
C2986546 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,2])
Item Group
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)".
C3889740 (UMLS CUI-1)
C2986547 (UMLS CUI-2)
C2986547 (UMLS CUI-2)
Non-Target Lesion Assessment Date
Item
Date of Assessment
date
C2985720 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
C2986547 (UMLS CUI [1,2])
Item
Overall Response of Non-Target Lesions:
text
C3272903 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
C2986547 (UMLS CUI [1,2])
CL Item
CR (CR)
CL Item
NE (NE)
CL Item
Non CR/Non PD (Non CR/Non PD)
CL Item
PD (PD)
Overall Response of Non-Target Lesion Specification
Item
If Response is NE, Please Specify the Reason:
text
C3272903 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C2986547 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Non-Target Lesion Progressive Disease Location
Item
If Response is PD, Please Specify the Concerned Non-Target Lesion(s) Below:
text
C2986547 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
C1335499 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
Item Group
Tumor Assessment - New Lesion
C3889740 (UMLS CUI-1)
C2986548 (UMLS CUI-2)
C2986548 (UMLS CUI-2)
New Lesion Location
Item
Lesion Location
text
C2986548 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
New Lesion Description
Item
New Lesion Description (Specify Exact Location)
text
C2986548 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
New Lesion Assessment Date
Item
Date of Assessment
date
C2986548 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
New Lesion Method of Measurement
Item
Method of Tumor Measurement
text
C2986548 (UMLS CUI [1,1])
C1299991 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,2])
Bone Scan Hot Spot
Item
In case of Bone scan done, indicate the total number of Hot spots:
float
C0203668 (UMLS CUI [1,1])
C0203637 (UMLS CUI [1,2])
C0203637 (UMLS CUI [1,2])
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
Present Pain Intensity and Analgesic Questionnaire for Cancer Pain (to follow until the first documented progression).
C0596240 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C0034394 (UMLS CUI-2)
Cancer Pain Questionnaire: Complete
Item
Was the Patient questionnaire completed for this visit?
boolean
C0596240 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Item
If NO, please specify the primary reason:
text
C0596240 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
C0034394 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
CL Item
Death (Death)
CL Item
Failure to distribute the questionnaire (Failure to distribute the questionnaire)
CL Item
Other (Other)
CL Item
Patient did not wish to show up (Patient did not wish to show up)
CL Item
Patient refusal (Patient refusal)
CL Item
Subject is unable due to toxicity disease (Subject is unable due to toxicity disease)
CL Item
Translation not available (Translation not available)
Cancer Pain Questionnaire: Primary Reason Specification
Item
If NO and OTHER, Specify:
text
C0596240 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0034394 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Pain Assessment: Date
Item
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Date
date
C1161170 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Present Pain Intensity
Item
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Present Pain Intensity
float
C1320357 (UMLS CUI [1])
Analgesic Score
Item
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Analgesic Score
text
C3202977 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
CL Item
No progression (No progression)
CL Item
Not evaluable (Not evaluable)
CL Item
Previously reported progression (Previously reported progression)
CL Item
Progression (please specify the assessment) (Progression (please specify the assessment))
Item
Disease Status: Progression - please specify the assessment:
text
C1335499 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
Code List
Disease Status: Progression - please specify the assessment:
CL Item
Pain (Pain)
CL Item
PSA (PSA)
CL Item
Tumor assessment (Tumor assessment)
Item Group
FACT P Questionnaire (to follow until the first documented progression).
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
C1549995 (UMLS CUI [1,1])
C3641634 (UMLS CUI [1,2])
C3641634 (UMLS CUI [1,2])
CL Item
Death (Death)
CL Item
Failure to distribute the questionnaire (Failure to distribute the questionnaire)
CL Item
Other (Other)
CL Item
Patient did not wish to show up (Patient did not wish to show up)
CL Item
Patient refusal (Patient refusal)
CL Item
Subject is unable due to toxicity disease (Subject is unable due to toxicity disease)
CL Item
Translation not available (Translation not available)
FACT P Questionnaire: Primary Reason Specification
Item
If OTHER, Specify:
text
C1549995 (UMLS CUI [1,1])
C3641634 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C3641634 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
FACT P Questionnaire: Date
Item
If YES, Please indicate how true each statement has been for the patient during the past 7 days: Date performed
date
C0011008 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,2])
Item Group
FACT P Questionnaire - Physical Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
C0517226 (UMLS CUI-1)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
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
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item
I am bothered by side effects of treatment.
text
C4289375 (UMLS CUI [1])
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item Group
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.
C3476515 (UMLS CUI-1)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item
I get emotional suport from my family.
text
C2984050 (UMLS CUI [1])
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item
My family has accepted my illness.
text
C0278069 (UMLS CUI [1,1])
C0015576 (UMLS CUI [1,2])
C0015576 (UMLS CUI [1,2])
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item
I am satisfied with my family communication about my illness.
text
C2984054 (UMLS CUI [1])
Code List
I am satisfied with my family communication about my illness.
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
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
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
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
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item Group
FACT P Questionnaire - Emotional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
C2984554 (UMLS CUI-1)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item
I am losing hope in the fight against my illness.
text
C2984056 (UMLS CUI [1])
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item
I worry that my condition will get worse.
text
C2984075 (UMLS CUI [1])
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item Group
FACT P Quesionnaire - Functional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
C3483376 (UMLS CUI-1)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item
I am content with the quality of my life right now.
text
C0034380 (UMLS CUI [1])
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item Group
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.
C3482667 (UMLS CUI-1)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item
I have aches and pains that bother me.
text
C3830278 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item
I have certain parts of my body where I experience pain.
text
C3641636 (UMLS CUI [1])
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
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
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
Item
My problems with urinating limit my activities.
text
C3641641 (UMLS CUI [1])
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)
CL Item
A little bit (A little bit)
CL Item
Not answered (Not answered)
CL Item
Not at all (Not at all)
CL Item
Quite a bit (Quite a bit)
CL Item
Somewhat (Somewhat)
CL Item
Very Much (Very Much)