ID

22525

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

June 6, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Pregnancy

English

CRFs Cabazitaxel Prostate Cancer NCT01308580 Pregnancy

1 forms  
Pregnancy of Partner
Description

Pregnancy of Partner

Alias
UMLS CUI-1
C0919624
Adverse Event (Diagnosis)
Description

Adverse Event Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
Date of Last Menses:
Description

Date of last menstrual period

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0425932
dd-mmm-yyyy
Visit Number
Description

Visit Number

Data type

float

Alias
UMLS CUI [1]
C1549755
Corrective Treatment/ Therapy
Description

Pregnancy: Corrective Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0719519
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0032961
Relationship: Is there reasonable possibiliy that the pregnancy was caused by the study treatment?
Description

Pregnancy: Reason

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0392360
Action Taken with CABAZITAXEL:
Description

Action Taken with Cabazitaxel

Data type

text

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C2830183
Outcome
Description

Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
Outcome If recovered: - Date of recovery:
Description

Date of recovery

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0237820
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
Outcome If recovered: - If sequelae, specify:
Description

Sequelae

Data type

text

Alias
UMLS CUI [1]
C0243088
Seriousness Criteria
Description

If YES: If Serious, please use the Last Page Link in the page navigation tool bar to view and complete the Safety Complementary Form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C0032961
If YES: - Date event became serious:
Description

Pregnancy: Date of Seriousness

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0032961
dd-mmm-yyyy
If YES: - Complete this section (Tick all criteria that apply):
Description

Pregnancy: Seriousness Criteria Specification

Data type

text

Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0032961
Safety Complementary Form
Description

Safety Complementary Form

Alias
UMLS CUI-1
C2697885
1. Demographic Information Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
2. Detailed Description of the Adverse Event (including complementary investigations) (Please start the description from the top row of the box in which a maximum of 800 characters is allowed. Please tab to continue entry after a warning beep for each set of 200 characters, displayed in two rows after a tab.)
Description

Adverse Event: Description

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0877248
3. Investigational Products Date of FIRST administration of study treatment:
Description

First Date of Administration of Study Treatment

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0805838
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0304229
dd-mmm-yyyy
3. Investigational Products Date of LAST administration before SAE: Prednisone/ Prednisolone
Description

Date of Last Administration: Prednisone

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0032952
dd-mmm-yyyy
3. Investigational Products Last Intended Dosage before SAE: Prednisone/ Prednisolone
Description

Last Intended Dose: Prednisone

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C1517741
UMLS CUI [1,2]
C1283828
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0032952
mg
3. Investigational Products Last Actual Dosage before SAE: Prednisone/ Prednisolone
Description

Last Actual Dose: Prednisone

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C1517741
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0032952
mg
3. Investigational Products Date of LAST administration before SAE: Cabazitaxel
Description

Date of Last Administration: Cabazitaxel

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C2830183
dd-mmm-yyyy
3. Investigational Products Last Intended Dosage before SAE: Cabazitaxel
Description

Last Intended Dose: Cabazitaxel

Data type

float

Measurement units
  • mg/m^2
Alias
UMLS CUI [1,1]
C1517741
UMLS CUI [1,2]
C1283828
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C2830183
mg/m^2
3. Investigational Products Last Actual Dosage before SAE: Cabazitaxel
Description

Last Actual Dose: Cabazitaxel

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C1517741
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C2830183
mg
4. In case of hospitalization Date of admission (hospital report to be sent)
Description

Date of Admission

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1302393
dd-mmm-yyyy
5. In case of death Autopsy report (copy to be sent)
Description

Autopsy Report

Data type

boolean

Alias
UMLS CUI [1]
C1548372
6. Corrective Treatment/ Therapy
Description

Corrective Treatment

Data type

text

Alias
UMLS CUI [1,1]
C0719519
UMLS CUI [1,2]
C0087111
Back to the top of the page

Similar models

CRFs Cabazitaxel Prostate Cancer NCT01308580 Pregnancy

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pregnancy of Partner
C0919624 (UMLS CUI-1)
Item
Adverse Event (Diagnosis)
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Adverse Event Diagnosis
Code List
Adverse Event (Diagnosis)
CL Item
Pregnancy of the Partner (Pregnancy of the Partner)
Date of last menstrual period
Item
Date of Last Menses:
date
C0425932 (UMLS CUI [1])
Visit Number
Item
Visit Number
float
C1549755 (UMLS CUI [1])
Pregnancy: Corrective Treatment
Item
Corrective Treatment/ Therapy
boolean
C0719519 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Pregnancy: Reason
Item
Relationship: Is there reasonable possibiliy that the pregnancy was caused by the study treatment?
boolean
C0032961 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Action Taken with Cabazitaxel
Item
Action Taken with CABAZITAXEL:
text
C2826626 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Date of recovery
Item
Outcome If recovered: - Date of recovery:
date
C0237820 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Sequelae
Item
Outcome If recovered: - If sequelae, specify:
text
C0243088 (UMLS CUI [1])
Pregnancy: Seriousness Criteria
Item
Seriousness Criteria
boolean
C0871902 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
Pregnancy: Date of Seriousness
Item
If YES: - Date event became serious:
date
C0871902 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Item
If YES: - Complete this section (Tick all criteria that apply):
text
C0871902 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Pregnancy: Seriousness Criteria Specification
Code List
If YES: - Complete this section (Tick all criteria that apply):
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Life threatening (Life threatening)
CL Item
Other medically important event (Other medically important event)
CL Item
Persistent/significant disablity/incapacity (Persistent/significant disablity/incapacity)
CL Item
Requiring/prolonging hospitalization (Requiring/prolonging hospitalization)
CL Item
Resulting in death (Resulting in death)
Item Group
Safety Complementary Form
C2697885 (UMLS CUI-1)
Weight
Item
1. Demographic Information Weight
float
C0005910 (UMLS CUI [1])
Adverse Event: Description
Item
2. Detailed Description of the Adverse Event (including complementary investigations) (Please start the description from the top row of the box in which a maximum of 800 characters is allowed. Please tab to continue entry after a warning beep for each set of 200 characters, displayed in two rows after a tab.)
text
C0678257 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
First Date of Administration of Study Treatment
Item
3. Investigational Products Date of FIRST administration of study treatment:
date
C0805838 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Date of Last Administration: Prednisone
Item
3. Investigational Products Date of LAST administration before SAE: Prednisone/ Prednisolone
date
C1762893 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
Last Intended Dose: Prednisone
Item
3. Investigational Products Last Intended Dosage before SAE: Prednisone/ Prednisolone
float
C1517741 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0032952 (UMLS CUI [1,4])
Last Actual Dose: Prednisone
Item
3. Investigational Products Last Actual Dosage before SAE: Prednisone/ Prednisolone
float
C1517741 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
Date of Last Administration: Cabazitaxel
Item
3. Investigational Products Date of LAST administration before SAE: Cabazitaxel
date
C1762893 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C2830183 (UMLS CUI [1,3])
Last Intended Dose: Cabazitaxel
Item
3. Investigational Products Last Intended Dosage before SAE: Cabazitaxel
float
C1517741 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C2830183 (UMLS CUI [1,4])
Last Actual Dose: Cabazitaxel
Item
3. Investigational Products Last Actual Dosage before SAE: Cabazitaxel
float
C1517741 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C2830183 (UMLS CUI [1,3])
Date of Admission
Item
4. In case of hospitalization Date of admission (hospital report to be sent)
date
C1302393 (UMLS CUI [1])
Autopsy Report
Item
5. In case of death Autopsy report (copy to be sent)
boolean
C1548372 (UMLS CUI [1])
Corrective Treatment
Item
6. Corrective Treatment/ Therapy
text
C0719519 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial