ID

22525

Beschreibung

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

Stichworte

Versionen (1)
  1. 06.06.17 06.06.17 -
Hochgeladen am

6. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Pregnancy

Englisch

CRFs Cabazitaxel Prostate Cancer NCT01308580 Pregnancy

1 Formulare  
Pregnancy of Partner
Beschreibung

Pregnancy of Partner

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

Adverse Event Diagnosis

Datentyp

text

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

Date of last menstrual period

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0425932
dd-mmm-yyyy
Visit Number
Beschreibung

Visit Number

Datentyp

float

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

Pregnancy: Corrective Treatment

Datentyp

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?
Beschreibung

Pregnancy: Reason

Datentyp

boolean

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

Action Taken with Cabazitaxel

Datentyp

text

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

Outcome

Datentyp

text

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

Date of recovery

Datentyp

date

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

Sequelae

Datentyp

text

Alias
UMLS CUI [1]
C0243088
Seriousness Criteria
Beschreibung

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

Datentyp

boolean

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

Pregnancy: Date of Seriousness

Datentyp

date

Maßeinheiten
  • 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):
Beschreibung

Pregnancy: Seriousness Criteria Specification

Datentyp

text

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

Safety Complementary Form

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

Weight

Datentyp

float

Maßeinheiten
  • 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.)
Beschreibung

Adverse Event: Description

Datentyp

text

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

First Date of Administration of Study Treatment

Datentyp

date

Maßeinheiten
  • 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
Beschreibung

Date of Last Administration: Prednisone

Datentyp

date

Maßeinheiten
  • 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
Beschreibung

Last Intended Dose: Prednisone

Datentyp

float

Maßeinheiten
  • 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
Beschreibung

Last Actual Dose: Prednisone

Datentyp

float

Maßeinheiten
  • 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
Beschreibung

Date of Last Administration: Cabazitaxel

Datentyp

date

Maßeinheiten
  • 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
Beschreibung

Last Intended Dose: Cabazitaxel

Datentyp

float

Maßeinheiten
  • 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
Beschreibung

Last Actual Dose: Cabazitaxel

Datentyp

float

Maßeinheiten
  • 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)
Beschreibung

Date of Admission

Datentyp

date

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

Autopsy Report

Datentyp

boolean

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

Corrective Treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0719519
UMLS CUI [1,2]
C0087111
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Ähnliche Modelle

CRFs Cabazitaxel Prostate Cancer NCT01308580 Pregnancy

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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