ID

22079

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. 5/18/17 5/18/17 -
Uploaded on

May 18, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 1

English

CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 1

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 - Day 01 - Not applicable if already done within 8 days prior to infusion.
Description

Vital Signs - Day 01 - Not applicable if already done within 8 days prior to infusion.

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

Body Weight

Data type

float

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

Systolic Blood Pressure

Data type

float

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

ECOG Performance Status

Data type

integer

Alias
UMLS CUI [1]
C1520224
Laboratory Tests Hematology - Day 01 - Not applicable if already done within 8 days prior to infusion. - Repeat on Day 08 and Day 15.
Description

Laboratory Tests Hematology - Day 01 - Not applicable if already done within 8 days prior to infusion. - Repeat on Day 08 and Day 15.

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

Note: Repeat on Day 01, 08, 15.

Data type

text

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

Hemoglobin

Data type

text

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 - Day 01 - Not applicable if already done within 8 days prior to infusion. Repeat on Day 08 (Sodium, Potassium, Calcium, Phosphorus, Blood Urea Nitrogen, Magnesium, Creatinine)
Description

Laboratory Tests Biochemistry - Day 01 - Not applicable if already done within 8 days prior to infusion. Repeat on Day 08 (Sodium, Potassium, Calcium, Phosphorus, Blood Urea Nitrogen, Magnesium, Creatinine)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005477
Date
Description

Note: Repeat on Day 01, 15.

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826641
UMLS CUI [1,2]
C0005477
dd-mmm-yyyy
Sodium
Description

Note: Repeat on Day 01, 15.

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Potassium
Description

Note: Repeat on Day 01, 15.

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202194
mmol/L
Calcium
Description

Note: Repeat on Day 01, 15.

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201925
mmol/L
Phosphorus
Description

Note: Repeat on Day 01, 15.

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0031705
mmol/L
Blood urea nitrogen
Description

Note: Repeat on Day 01, 15.

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0005845
mmol/L
Magnesium
Description

Note: Repeat on Day 01, 15.

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

Note: Repeat on Day 01, 15.

Data type

float

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

Note: Repeat on Day 01, 15.

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
Medication - Pre Medication: Record all medications that the subject has taken prior to the Day 01 study treatment as premedication.
Description

Medication - Pre Medication: Record all medications that the subject has taken prior to the Day 01 study treatment as premedication.

Alias
UMLS CUI-1
C0033045
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
Dosage (Total daily dose)
Description

Total daily dose

Data type

float

Alias
UMLS CUI [1]
C2348070
Dose Unit
Description

Dose Unit

Data type

text

Alias
UMLS CUI [1]
C2826646
Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

Premedication: Start Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0033045
dd-mmm-yyyy
End Date
Description

Premedication: End Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0033045
dd-mmm-yyyy
Investigational Product Administration - Prednisone/ Prednisolone
Description

Investigational Product Administration - Prednisone/ Prednisolone

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1533734
UMLS CUI-3
C0032952
Intended Daily Dose
Description

Prednisone: Intended Daily Dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C1283828
UMLS CUI [1,3]
C2348070
mg
Actual Total Dose
Description

Prednisone: Actual Total Dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C3174092
mg
Number of day with no intake
Description

Prednisone: Number of day with no intake

Data type

float

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0332453
Investigational Product Administration - Cabazitaxel
Description

Investigational Product Administration - Cabazitaxel

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1533734
UMLS CUI-3
C2830183
Scheduled Period
Description

Cabazitaxel: Scheduled Period

Data type

text

Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C0205539
Batch Number
Description

Cabazitaxel: Batch Number

Data type

text

Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C3641829
Start Date
Description

Cabazitaxel: Start Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C0808070
dd-mmm-yyyy
Start Time
Description

Cabazitaxel: Start Time

Data type

time

Measurement units
  • 24-hours clock
Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C1301880
24-hours clock
End time
Description

Cabazitaxel: End Time

Data type

time

Measurement units
  • 24-hours clock
Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C1522314
24-hours clock
Intended Dose
Description

Cabazitaxel: Intended Dose

Data type

float

Measurement units
  • mg/m^2
Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C1283828
UMLS CUI [1,3]
C2348070
mg/m^2
Administration Route
Description

Cabazitaxel: Administration Route

Data type

text

Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C0013153
Actual Dose
Description

Cabazitaxel: Actual Dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C3174092
mg
If dose interrupted and readministered, please report the information below: Cabazitaxel
Description

If dose interrupted and readministered, please report the information below: Cabazitaxel

Alias
UMLS CUI-1
C1512900
UMLS CUI-2
C2830183
Scheduled Period
Description

Interruption Cabazitaxel: Scheduled Period

Data type

text

Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C2830183
UMLS CUI [1,3]
C0205539
Batch Number
Description

Interruption Cabazitaxel: Batch Number

Data type

text

Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C2830183
UMLS CUI [1,3]
C3641829
Start Date
Description

Interruption Cabazitaxel: Start Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C2830183
UMLS CUI [1,3]
C0808070
dd-mmm-yyyy
Start Time
Description

Interruption Cabazitaxel: Start Time

Data type

time

Measurement units
  • 24-hours clock
Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C2830183
UMLS CUI [1,3]
C1301880
24-hours clock
End Time
Description

Interruption Cabazitaxel: End Time

Data type

time

Measurement units
  • 24-hours clock
Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C2830183
UMLS CUI [1,3]
C1522314
24-hours clock
Administration Route
Description

Interruption Cabazitaxel: Administration Route

Data type

text

Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C2830183
UMLS CUI [1,3]
C0013153
Actual Dose
Description

Interruption Cabazitaxel: Actual Dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C2830183
UMLS CUI [1,3]
C3174092
mg
Cabazitaxel Pharmacokinetic - Blood Sampling
Description

Cabazitaxel Pharmacokinetic - Blood Sampling

Alias
UMLS CUI-1
C2830183
UMLS CUI-2
C0031328
UMLS CUI-3
C0005834
Date of Sample
Description

Sample ID: P00 - Theoretical Time: 5 min before the end of infusion (D01-T0H55) Sample ID: P01 - Theoretical Time: 15 min after the end of infusion (D01-T1H15) Sample ID: P02 - Theoretical Time: 1 - 4 hours after the end of infusion (D01-T2H00) Sample ID: P03 - Theoretical Time: 6 - 24 hours after the end of infusion (D01-T7H00) Sample ID: P04 - Theoretical Time: 48 - 168 hours after the end of infusion (D01-T49H00)

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1317250
dd-mmm-yyyy
Time
Description

Sample ID: P00 - Theoretical Time: 5 min before the end of infusion (D01-T0H55) Sample ID: P01 - Theoretical Time: 15 min after the end of infusion (D01-T1H15) Sample ID: P02 - Theoretical Time: 1 - 4 hours after the end of infusion (D01-T2H00) Sample ID: P03 - Theoretical Time: 6 - 24 hours after the end of infusion (D01-T7H00) Sample ID: P04 - Theoretical Time: 48 - 168 hours after the end of infusion (D01-T49H00)

Data type

time

Measurement units
  • 24-hours clock
Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0040223
24-hours clock
Cabazitaxel Pharmacogenomic - Blood Sampling
Description

Cabazitaxel Pharmacogenomic - Blood Sampling

Alias
UMLS CUI-1
C2830183
UMLS CUI-2
C1138555
UMLS CUI-3
C0005834
Date of Sample
Description

Sample ID: B00 - Theoretical Time: Prior Infusion

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C1138555
UMLS CUI [1,3]
C1317250
dd-mmm-yyyy
Macroscopic Hematuria
Description

Macroscopic Hematuria

Alias
UMLS CUI-1
C0473237
Does the patient experience Macroscopic Hematuria during this cycle?
Description

Macroscopic Hematuria

Data type

boolean

Alias
UMLS CUI [1]
C0473237
If YES, specify the cause:
Description

* Please report the cause as AE ** Please report "Macroscopic Hematuria" as AE

Data type

text

Alias
UMLS CUI [1,1]
C0473237
UMLS CUI [1,2]
C0015127
If YES and OTHER, specify:
Description

Macroscopic Hematuria: Cause Specification

Data type

text

Alias
UMLS CUI [1,1]
C0473237
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C2348235
Did you perform specific exams to document the cause?
Description

Note: If YES, please report the exam in the "OTHER PROCEDURES" page.

Data type

boolean

Alias
UMLS CUI [1,1]
C0473237
UMLS CUI [1,2]
C0582103
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). 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). 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 - to be performed prior to the next study drug infusion.
Description

Tumor Markers - to follow until PSA progression - to be performed prior to the next study drug infusion.

Alias
UMLS CUI-1
C0041365
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
Test: PSA
Description

Tumor Markers: PSA Test

Data type

text

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C0201544
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).

Alias
UMLS CUI-1
C3641634
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 support from my friends.
Description

Emotional Support from friends

Data type

text

Alias
UMLS CUI [1,1]
C0600015
UMLS CUI [1,2]
C0079382
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
FACT P Questionnaire - Additional Concerns: If YES, Please indicate how true each statement has been for the patient during the past 7 days.
Description

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 Cycle 1

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 - Day 01 - Not applicable if already done within 8 days prior to infusion.
C0518766 (UMLS CUI-1)
Assessment Date
Item
Date performed:
date
C2985720 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
float
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
float
C0018810 (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
Laboratory Tests Hematology - Day 01 - Not applicable if already done within 8 days prior to infusion. - Repeat on Day 08 and Day 15.
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Laboratory Test Date
Item
Date
text
C2826641 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
text
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 - Day 01 - Not applicable if already done within 8 days prior to infusion. Repeat on Day 08 (Sodium, Potassium, Calcium, Phosphorus, Blood Urea Nitrogen, Magnesium, Creatinine)
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
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
Medication - Pre Medication: Record all medications that the subject has taken prior to the Day 01 study treatment as premedication.
C0033045 (UMLS CUI-1)
Medication
Item
Drug/Medication (Brand or generic name)
text
C0013227 (UMLS CUI [1])
Item
Reason
text
C3146298 (UMLS CUI [1])
Indication
Code List
Reason
CL Item
Prophylaxis (Prophylaxis)
Total daily dose
Item
Dosage (Total daily dose)
float
C2348070 (UMLS CUI [1])
Dose Unit
Item
Dose Unit
text
C2826646 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Premedication: Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0033045 (UMLS CUI [1,2])
Premedication: End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0033045 (UMLS CUI [1,2])
Item Group
Investigational Product Administration - Prednisone/ Prednisolone
C0304229 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
C0032952 (UMLS CUI-3)
Prednisone: Intended Daily Dose
Item
Intended Daily Dose
float
C0032952 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
Prednisone: Actual Total Dose
Item
Actual Total Dose
float
C0032952 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Prednisone: Number of day with no intake
Item
Number of day with no intake
float
C0032952 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0332453 (UMLS CUI [1,4])
Item Group
Investigational Product Administration - Cabazitaxel
C0304229 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
C2830183 (UMLS CUI-3)
Item
Scheduled Period
text
C2830183 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Cabazitaxel: Scheduled Period
Code List
Scheduled Period
CL Item
Day 01 (Day 01)
Cabazitaxel: Batch Number
Item
Batch Number
text
C2830183 (UMLS CUI [1,1])
C3641829 (UMLS CUI [1,2])
Cabazitaxel: Start Date
Item
Start Date
date
C2830183 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Cabazitaxel: Start Time
Item
Start Time
time
C2830183 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Cabazitaxel: End Time
Item
End time
time
C2830183 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Cabazitaxel: Intended Dose
Item
Intended Dose
float
C2830183 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
Item
Administration Route
text
C2830183 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Cabazitaxel: Administration Route
Code List
Administration Route
CL Item
IV (IV)
Cabazitaxel: Actual Dose
Item
Actual Dose
float
C2830183 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item Group
If dose interrupted and readministered, please report the information below: Cabazitaxel
C1512900 (UMLS CUI-1)
C2830183 (UMLS CUI-2)
Interruption Cabazitaxel: Scheduled Period
Item
Scheduled Period
text
C1512900 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Interruption Cabazitaxel: Batch Number
Item
Batch Number
text
C1512900 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
C3641829 (UMLS CUI [1,3])
Interruption Cabazitaxel: Start Date
Item
Start Date
date
C1512900 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Interruption Cabazitaxel: Start Time
Item
Start Time
time
C1512900 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Interruption Cabazitaxel: End Time
Item
End Time
time
C1512900 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Administration Route
text
C1512900 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Interruption Cabazitaxel: Administration Route
Code List
Administration Route
CL Item
IV (IV)
Interruption Cabazitaxel: Actual Dose
Item
Actual Dose
float
C1512900 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Item Group
Cabazitaxel Pharmacokinetic - Blood Sampling
C2830183 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
Cabazitaxel Pharmacokinetic - Date of Sample
Item
Date of Sample
date
C2830183 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,3])
Cabazitaxel Pharmacokinetic: Time
Item
Time
time
C2830183 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Cabazitaxel Pharmacogenomic - Blood Sampling
C2830183 (UMLS CUI-1)
C1138555 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
Cabazitaxel Pharmacogenomic: Date of Sample
Item
Date of Sample
date
C2830183 (UMLS CUI [1,1])
C1138555 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,3])
Item Group
Macroscopic Hematuria
C0473237 (UMLS CUI-1)
Macroscopic Hematuria
Item
Does the patient experience Macroscopic Hematuria during this cycle?
boolean
C0473237 (UMLS CUI [1])
Item
If YES, specify the cause:
text
C0473237 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Macroscopic Hematuria: Cause
Code List
If YES, specify the cause:
CL Item
Local infection* (Local infection*)
CL Item
Bladder mucositis (non infectious)* (Bladder mucositis (non infectious)*)
CL Item
Local progression/ obstruction** (Local progression/ obstruction**)
CL Item
Anticoagulation/ Aspirin therapy** (Anticoagulation/ Aspirin therapy**)
CL Item
Thrombocytopenia** (Thrombocytopenia**)
CL Item
No cause identified** (No cause identified**)
CL Item
Stones* (Stones*)
CL Item
Non steroid anti-inflammatory drug** (Non steroid anti-inflammatory drug**)
CL Item
Other (Other)
Macroscopic Hematuria: Cause Specification
Item
If YES and OTHER, specify:
text
C0473237 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Macroscopic Hematuria: Examination
Item
Did you perform specific exams to document the cause?
boolean
C0473237 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
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). 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
Non CR/Non PD (Non CR/Non PD)
CL Item
PD (PD)
CL Item
NE (NE)
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 - to be performed prior to the next study drug infusion.
C0041365 (UMLS CUI-1)
Tumor Markers: Assessment Date
Item
Date of evaluation
date
C0041365 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
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: 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
Subject is unable due to toxicity disease (Subject is unable due to toxicity disease)
CL Item
Failure to distribute the questionnaire (Failure to distribute the questionnaire)
CL Item
Patient refusal (Patient refusal)
CL Item
Death (Death)
CL Item
Patient did not wish to show up (Patient did not wish to show up)
CL Item
Translation not available (Translation not available)
CL Item
Other (Other)
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
Not evaluable (Not evaluable)
CL Item
Previously reported progression (Previously reported progression)
CL Item
No progression (No 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
Tumor assessment (Tumor assessment)
CL Item
PSA (PSA)
CL Item
Pain (Pain)
Item Group
FACT P Questionnaire (to follow until the first documented progression).
C3641634 (UMLS CUI-1)
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
Subject is unable due to toxicity disease (Subject is unable due to toxicity disease)
CL Item
Failure to distribute the questionnaire (Failure to distribute the questionnaire)
CL Item
Patient refusal (Patient refusal)
CL Item
Death (Death)
CL Item
Patient did not wish to show up (Patient did not wish to show up)
CL Item
Translation not available (Translation not available)
CL Item
Other (Other)
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 support from my friends.
text
C0600015 (UMLS CUI [1,1])
C0079382 (UMLS CUI [1,2])
Emotional Support from friends
Code List
I get emotional 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
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
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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