ID

22859

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. 6/13/17 6/13/17 -
Uploaded on

June 13, 2017

DOI

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License

Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Follow-Up 13

English

CRFs Cabazitaxel Prostate Cancer NCT01308580 Follow-Up 13

1 forms  
Visit Information
Description

Visit Information

Alias
UMLS CUI-1
C0545082
Date of Visit:
Description

Date of Visit

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Vital Signs
Description

Vital Signs

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
Performance Status: ECOG
Description

ECOG Performance Status

Data type

integer

Alias
UMLS CUI [1]
C1520224
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)".
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
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)`.
Description

Target Lesion Number

Data type

float

Alias
UMLS CUI [1,1]
C0449791
UMLS CUI [1,2]
C2986546
Lesion Location
Description

Target Lesion Location

Data type

text

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C2986546
Lesion Description (Subsite)
Description

Target Lesion Description

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C2986546
Date of Assessment
Description

Target Lesion Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C2985720
dd-mmm-yyyy
Method of Tumor Measurement
Description

Target Lesion Method of Measurement

Data type

text

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C2986546
Measurement of Target Lesion: Diameter
Description

Target Lesion Diameter

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1301886
mm
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)".
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
Date of Assessment
Description

Non-Target Lesion Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C2986547
dd-mmm-yyyy
Overall Response of Non-Target Lesions:
Description

Overall Response of Non-Target Lesion

Data type

text

Alias
UMLS CUI [1,1]
C3272903
UMLS CUI [1,2]
C2986547
If Response is NE, Please Specify the Reason:
Description

Overall Response of Non-Target Lesion Specification

Data type

text

Alias
UMLS CUI [1,1]
C3272903
UMLS CUI [1,2]
C2986547
UMLS CUI [1,3]
C2348235
If Response is PD, Please Specify the Concerned Non-Target Lesion(s) Below:
Description

Non-Target Lesion Progressive Disease Location

Data type

text

Alias
UMLS CUI [1,1]
C2986547
UMLS CUI [1,2]
C1335499
UMLS CUI [1,3]
C0450429
Tumor Assessment - New Lesion
Description

Tumor Assessment - New Lesion

Alias
UMLS CUI-1
C3889740
UMLS CUI-2
C2986548
Lesion Location
Description

New Lesion Location

Data type

text

Alias
UMLS CUI [1,1]
C2986548
UMLS CUI [1,2]
C0450429
New Lesion Description (Specify Exact Location)
Description

New Lesion Description

Data type

text

Alias
UMLS CUI [1,1]
C2986548
UMLS CUI [1,2]
C0678257
Date of Assessment
Description

New Lesion Assessment Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2986548
UMLS CUI [1,2]
C2985720
dd-mmm-yyyy
Method of Tumor Measurement
Description

New Lesion Method of Measurement

Data type

text

Alias
UMLS CUI [1,1]
C2986548
UMLS CUI [1,2]
C1299991
Bone Check (to follow until radiological progression)
Description

Bone Check (to follow until radiological progression)

Alias
UMLS CUI-1
C0203668
In case of Bone scan done, indicate the total number of Hot spots:
Description

Bone Scan Hot Spot

Data type

float

Alias
UMLS CUI [1,1]
C0203668
UMLS CUI [1,2]
C0203637
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
Present Pain Intensity and Analgesic Questionnaire for Cancer Pain (to follow until the first documented progression).
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
Was the Patient questionnaire completed for this visit?
Description

Cancer Pain Questionnaire: Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C0596240
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0205197
If NO, please specify the primary reason:
Description

Cancer Pain Questionnaire: Primary Reason

Data type

text

Alias
UMLS CUI [1,1]
C0596240
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C1549995
If NO and OTHER, Specify:
Description

Cancer Pain Questionnaire: Primary Reason Specification

Data type

text

Alias
UMLS CUI [1,1]
C0596240
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C1549995
UMLS CUI [1,4]
C2348235
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Date
Description

Note: Repeat on Day 01, 02, 03, 04, 05, 06, 07.

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1161170
UMLS CUI [1,2]
C2985720
dd-mmm-yyyy
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Present Pain Intensity
Description

Note: Repeat on Day 01, 02, 03, 04, 05, 06, 07.

Data type

float

Alias
UMLS CUI [1]
C1320357
If YES, Please complete the PAIN ASSESSMENT below: Date Corresponds to current cycle (7 days prior to dosing Day 1) Analgesic Score
Description

Note: Repeat on Day 01, 02, 03, 04, 05, 06, 07.

Data type

text

Alias
UMLS CUI [1,1]
C3202977
UMLS CUI [1,2]
C0449820
Disease Status
Description

Disease Status

Alias
UMLS CUI-1
C0699749
Disease Status (tick one box only):
Description

Disease Status

Data type

text

Alias
UMLS CUI [1]
C0699749
Disease Status: Progression - please specify the assessment:
Description

Progressive Disease: Assessment

Data type

text

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0220825
FACT P Questionnaire (to follow until the first documented progression).
Description

FACT P Questionnaire (to follow until the first documented progression).

Was the assessment performed at this visit?
Description

FACT P Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3641634
If NO, please specify the primary reason:
Description

FACT P Questionnaire: Primary Reason

Data type

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C3641634
If OTHER, Specify:
Description

FACT P Questionnaire: Primary Reason Specification

Data type

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C3641634
UMLS CUI [1,3]
C2348235
If YES, Please indicate how true each statement has been for the patient during the past 7 days: Date performed
Description

FACT P Questionnaire: Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1549995
dd-mmm-yyyy
FACT P Questionnaire - Physical Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
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
I have a lack of energy.
Description

Lack of Energy

Data type

text

Alias
UMLS CUI [1]
C4048330
I have nausea.
Description

Nausea

Data type

text

Alias
UMLS CUI [1]
C0027497
Because of my physical condition, I have trouble meeting the needs of my family
Description

Trouble meeting needs of family

Data type

text

Alias
UMLS CUI [1]
C4287855
I have Pain.
Description

Pain

Data type

text

Alias
UMLS CUI [1]
C0030193
I am bothered by side effects of treatment.
Description

Bothered by side effects of treatment

Data type

text

Alias
UMLS CUI [1]
C4289375
I feel ill.
Description

Illness

Data type

text

Alias
UMLS CUI [1]
C0221423
I am forced to spend time in bed.
Description

Time spend in bed

Data type

text

Alias
UMLS CUI [1]
C4289366
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.
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
I feel close to my friends.
Description

Feel Close to Friends

Data type

text

Alias
UMLS CUI [1]
C2984048
I get emotional suport from my family.
Description

Emotional Support from family

Data type

text

Alias
UMLS CUI [1]
C2984050
I get support from my friends.
Description

Receive Support from Friends

Data type

text

Alias
UMLS CUI [1]
C2984072
My family has accepted my illness.
Description

Illness acceptancy by family

Data type

text

Alias
UMLS CUI [1,1]
C0278069
UMLS CUI [1,2]
C0015576
I am satisfied with my family communication about my illness.
Description

Satisfied with Family Communication

Data type

text

Alias
UMLS CUI [1]
C2984054
I feel close to my partner (or the person who is my main support).
Description

Feeling close to partner

Data type

text

Alias
UMLS CUI [1]
C2984059
(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.
Description

Satisfied with Sex Life

Data type

text

Alias
UMLS CUI [1]
C2984060
FACT P Questionnaire - Emotional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
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
I feel sad.
Description

Feeling sad

Data type

text

Alias
UMLS CUI [1]
C3536794
I am satisfied with how I am coping with my illness.
Description

Coping

Data type

text

Alias
UMLS CUI [1]
C0009967
I am losing hope in the fight against my illness.
Description

Losing hope against illness

Data type

text

Alias
UMLS CUI [1]
C2984056
I feel nervous.
Description

Feeling nervous

Data type

text

Alias
UMLS CUI [1]
C0849963
I worry about dying.
Description

Worry About Dying

Data type

text

Alias
UMLS CUI [1]
C2984076
I worry that my condition will get worse.
Description

Worry About Worsening Condition

Data type

text

Alias
UMLS CUI [1]
C2984075
FACT P Quesionnaire - Functional Well-Being: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
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
I am able to work (include work at home).
Description

Able to work

Data type

text

Alias
UMLS CUI [1]
C2984044
My Work (include work at home) is fulfilling.
Description

Work is fulfilling

Data type

text

Alias
UMLS CUI [1]
C2984074
I am able to enjoy life.
Description

Able to enjoy life

Data type

text

Alias
UMLS CUI [1]
C2984051
I have accepted my illness.
Description

Acceptance of illness

Data type

text

Alias
UMLS CUI [1]
C0278069
I am sleeping well.
Description

Sleeping behaviour

Data type

text

Alias
UMLS CUI [1]
C0474396
I am enjoying the things I usually do for fun.
Description

Anhedonia

Data type

text

Alias
UMLS CUI [1]
C0178417
I am content with the quality of my life right now.
Description

Quality of life

Data type

text

Alias
UMLS CUI [1]
C0034380
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.
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
I am losing weight.
Description

Losing Weight

Data type

text

Alias
UMLS CUI [1]
C1262477
I have a good appetite.
Description

Appetite

Data type

text

Alias
UMLS CUI [1]
C0003618
I have aches and pains that bother me.
Description

Bothered by pain

Data type

text

Alias
UMLS CUI [1,1]
C3830278
UMLS CUI [1,2]
C0030193
I have certain parts of my body where I experience pain.
Description

Painful Body Parts

Data type

text

Alias
UMLS CUI [1]
C3641636
My pain keeps me from doing things I want to do.
Description

Pain Keeps Me From Doing Things I Want to Do

Data type

text

Alias
UMLS CUI [1]
C3641680
I am satisfied with my present comfort level.
Description

Comfort Level

Data type

text

Alias
UMLS CUI [1]
C0517225
I am able to feel like a man.
Description

Feel like a man

Data type

text

Alias
UMLS CUI [1]
C3641638
I have trouble moving my bowels.
Description

Trouble Moving Bowels

Data type

text

Alias
UMLS CUI [1]
C3641639
I have difficulty urinating.
Description

Difficulty urinating

Data type

text

Alias
UMLS CUI [1]
C0241705
I urinate more frequently than usual.
Description

Frequency of urination

Data type

text

Alias
UMLS CUI [1]
C2584336
My problems with urinating limit my activities.
Description

Activities Limited by Urination Problems

Data type

text

Alias
UMLS CUI [1]
C3641641
I am able to have and maintain an erection.
Description

Erection

Data type

text

Alias
UMLS CUI [1]
C0030847
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Similar models

CRFs Cabazitaxel Prostate Cancer NCT01308580 Follow-Up 13

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Visit Information
C0545082 (UMLS CUI-1)
Date of Visit
Item
Date of Visit:
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Assessment Date
Item
Date performed:
date
C2985720 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (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
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)
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])
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 Assessment Date
Item
Date of Assessment
date
C2986546 (UMLS CUI [1,1])
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])
Target Lesion Diameter
Item
Measurement of Target Lesion: Diameter
float
C2986546 (UMLS CUI [1,1])
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)
Non-Target Lesion Assessment Date
Item
Date of Assessment
date
C2985720 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
Item
Overall Response of Non-Target Lesions:
text
C3272903 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
Overall Response of Non-Target Lesion
Code List
Overall Response of Non-Target Lesions:
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])
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])
Item Group
Tumor Assessment - New Lesion
C3889740 (UMLS CUI-1)
C2986548 (UMLS CUI-2)
New Lesion Location
Item
Lesion Location
text
C2986548 (UMLS CUI [1,1])
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])
New Lesion Assessment Date
Item
Date of Assessment
date
C2986548 (UMLS CUI [1,1])
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])
Item Group
Bone Check (to follow until radiological progression)
C0203668 (UMLS CUI-1)
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])
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
Present Pain Intensity and Analgesic Questionnaire for Cancer Pain (to follow until the first documented progression).
C0596240 (UMLS CUI-1)
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])
Item
If NO, please specify the primary reason:
text
C0596240 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
Cancer Pain Questionnaire: Primary Reason
Code List
If NO, please specify the primary reason:
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])
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])
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])
Item Group
Disease Status
C0699749 (UMLS CUI-1)
Item
Disease Status (tick one box only):
text
C0699749 (UMLS CUI [1])
Disease Status
Code List
Disease Status (tick one box only):
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])
Progressive Disease: Assessment
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])
FACT P Questionnaire: Primary Reason
Code List
If NO, please specify the primary reason:
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])
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])
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)
Item
I have a lack of energy.
text
C4048330 (UMLS CUI [1])
Lack of Energy
Code List
I have a lack of energy.
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 nausea.
text
C0027497 (UMLS CUI [1])
Nausea
Code List
I have nausea.
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])
Trouble meeting needs of family
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)
Item
I have Pain.
text
C0030193 (UMLS CUI [1])
Pain
Code List
I have Pain.
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])
Bothered by side effects of treatment
Code List
I am bothered by side effects of treatment.
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 ill.
text
C0221423 (UMLS CUI [1])
Illness
Code List
I feel ill.
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 forced to spend time in bed.
text
C4289366 (UMLS CUI [1])
Time spend in bed
Code List
I am forced to spend time in bed.
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)
Item
I feel close to my friends.
text
C2984048 (UMLS CUI [1])
Feel Close to Friends
Code List
I feel close to my friends.
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])
Emotional Support from family
Code List
I get emotional suport from 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)
Item
I get support from my friends.
text
C2984072 (UMLS CUI [1])
Receive Support from Friends
Code List
I get support from my friends.
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])
Illness acceptancy by family
Code List
My family has accepted 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 am satisfied with my family communication about my illness.
text
C2984054 (UMLS CUI [1])
Satisfied with Family Communication
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])
Feeling close to partner
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])
Satisfied with Sex Life
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)
Item
I feel sad.
text
C3536794 (UMLS CUI [1])
Feeling sad
Code List
I feel sad.
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 how I am coping with my illness.
text
C0009967 (UMLS CUI [1])
Coping
Code List
I am satisfied with how I am coping with 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 am losing hope in the fight against my illness.
text
C2984056 (UMLS CUI [1])
Losing hope against illness
Code List
I am losing hope in the fight against 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 nervous.
text
C0849963 (UMLS CUI [1])
Feeling nervous
Code List
I feel nervous.
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 about dying.
text
C2984076 (UMLS CUI [1])
Worry About Dying
Code List
I worry about dying.
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])
Worry About Worsening Condition
Code List
I worry that my condition will get worse.
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)
Item
I am able to work (include work at home).
text
C2984044 (UMLS CUI [1])
Able to work
Code List
I am able to work (include work at home).
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 Work (include work at home) is fulfilling.
text
C2984074 (UMLS CUI [1])
Work is fulfilling
Code List
My Work (include work at home) is fulfilling.
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 able to enjoy life.
text
C2984051 (UMLS CUI [1])
Able to enjoy life
Code List
I am able to enjoy 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
I have accepted my illness.
text
C0278069 (UMLS CUI [1])
Acceptance of illness
Code List
I have accepted 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 am sleeping well.
text
C0474396 (UMLS CUI [1])
Sleeping behaviour
Code List
I am sleeping well.
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 enjoying the things I usually do for fun.
text
C0178417 (UMLS CUI [1])
Anhedonia
Code List
I am enjoying the things I usually do for fun.
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])
Quality of life
Code List
I am content with the quality of my life right now.
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)
Item
I am losing weight.
text
C1262477 (UMLS CUI [1])
Losing Weight
Code List
I am losing weight.
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 a good appetite.
text
C0003618 (UMLS CUI [1])
Appetite
Code List
I have a good appetite.
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])
Bothered by pain
Code List
I have aches and pains that bother me.
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])
Painful Body Parts
Code List
I have certain parts of my body where I experience pain.
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])
Pain Keeps Me From Doing Things I Want to Do
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)
Item
I am satisfied with my present comfort level.
text
C0517225 (UMLS CUI [1])
Comfort Level
Code List
I am satisfied with my present comfort level.
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 able to feel like a man.
text
C3641638 (UMLS CUI [1])
Feel like a man
Code List
I am able to feel like a man.
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 trouble moving my bowels.
text
C3641639 (UMLS CUI [1])
Trouble Moving Bowels
Code List
I have trouble moving my bowels.
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 difficulty urinating.
text
C0241705 (UMLS CUI [1])
Difficulty urinating
Code List
I have difficulty urinating.
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 urinate more frequently than usual.
text
C2584336 (UMLS CUI [1])
Frequency of urination
Code List
I urinate more frequently than usual.
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])
Activities Limited by Urination Problems
Code List
My problems with urinating limit my activities.
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 able to have and maintain an erection.
text
C0030847 (UMLS CUI [1])
Erection
Code List
I am able to have and maintain an erection.
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)
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