ID

22253

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. 26.05.17 26.05.17 -
Hochgeladen am

26. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Adverse Event

Englisch

CRFs Cabazitaxel Prostate Cancer NCT01308580 Adverse Event

1 Formulare  
Adverse Event (Section 1/3)
Beschreibung

Adverse Event (Section 1/3)

Alias
UMLS CUI-1
C0877248
Initial AE Form Number:
Beschreibung

Complete with initial AE Form Nuber for previously reported AE.

Datentyp

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0877248
Adverse Event (Diagnosis)
Beschreibung

Adverse Event: Diagnosis

Datentyp

text

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

Start Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0808070
dd-mmm-yyyy
Visit Number
Beschreibung

Adverse Event: Visit Number

Datentyp

float

Alias
UMLS CUI [1,1]
C1549755
UMLS CUI [1,2]
C0877248
Grade
Beschreibung

Adverse Event: Grade

Datentyp

float

Alias
UMLS CUI [1]
C2985911
Corrective Treatment/Therapy?
Beschreibung

Adverse Event: Corrective Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0719519
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0877248
Relationship: Is there a reasonable possibility that the AE was caused by the study treatment?
Beschreibung

Adverse Event: Reason

Datentyp

boolean

Alias
UMLS CUI [1]
C3828190
Action Taken with CABAZITAXEL:
Beschreibung

Action Taken with Cabazitaxel

Datentyp

text

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

Adverse Event: Outcome

Datentyp

text

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

Adverse Event: Recovery Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2004454
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0877248
dd-mmm-yyyy
If recovered: - If sequelae, specify:
Beschreibung

Adverse Event: Sequelae

Datentyp

text

Alias
UMLS CUI [1,1]
C0243088
UMLS CUI [1,2]
C0877248
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]
C0877248
If YES: - Date event became serious:
Beschreibung

Adverse Event: Date of Seriousness

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0877248
dd-mmm-yyyy
If YES: - Complete this section (Tick all criteria that apply):
Beschreibung

Adverse Event: Seriousness Criteria Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0877248
Adverse Event - Ongoing without Change (Section 2/3) (Section to be completed if NO CHANGE from previous cycle. If there are changes, scroll down and complete the ONGOING WITH CHANGE section 3/3.)
Beschreibung

Adverse Event - Ongoing without Change (Section 2/3) (Section to be completed if NO CHANGE from previous cycle. If there are changes, scroll down and complete the ONGOING WITH CHANGE section 3/3.)

Alias
UMLS CUI-1
C0549178
UMLS CUI-2
C0205360
UMLS CUI-3
C0877248
Visit Number
Beschreibung

Adverse Event - Ongoing without Change: Visit Number

Datentyp

float

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C1549755
UMLS CUI [1,4]
C0877248
Ongoing without Change
Beschreibung

Adverse Event - Ongoing without Change

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0877248
Adverse Event - Ongoing with Change (Section 3/3)
Beschreibung

Adverse Event - Ongoing with Change (Section 3/3)

Alias
UMLS CUI-1
C0549178
UMLS CUI-2
C0443172
UMLS CUI-3
C0877248
Visit Number
Beschreibung

Adverse Event - Ongoing with Change: Visit Number

Datentyp

float

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C1549755
UMLS CUI [1,4]
C0877248
Grade
Beschreibung

Adverse Event - Ongoing with Change: Grade

Datentyp

float

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C2985911
UMLS CUI [1,4]
C0877248
Corrective Treatment/ Therapy?
Beschreibung

Adverse Event - Ongoing with Change: Corrective Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0719519
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0443172
UMLS CUI [1,5]
C0877248
Relationship: Is there a reasonable possibility that the AE was caused by the study treatment?
Beschreibung

Adverse Event - Ongoing with Change: Reason

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3828190
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0443172
Action Taken with CABAZITAXEL:
Beschreibung

Adverse Event - Ongoing with Change: Action Taken with Cabazitaxel

Datentyp

text

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C2830183
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0443172
UMLS CUI [1,5]
C0877248
Outcome
Beschreibung

Adverse Event - Ongoing with Change: Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0443172
If recovered: - Date of recovery
Beschreibung

Adverse Event - Ongoing with Change: Recovery Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2004454
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0443172
UMLS CUI [1,5]
C0877248
dd-mmm-yyyy
If recovered: - If sequelae, specify:
Beschreibung

Adverse Event - Ongoing with Change: Sequelae

Datentyp

text

Alias
UMLS CUI [1,1]
C0243088
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0443172
UMLS CUI [1,4]
C0877248
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]
C0549178
UMLS CUI [1,3]
C0443172
UMLS CUI [1,4]
C0877248
If YES: - Date event became serious:
Beschreibung

Adverse Event - Ongoing with Change: Date of Seriousness

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0443172
UMLS CUI [1,5]
C0877248
dd-mmm-yyyy
If YES: - Complete this section (Tick all criteria that apply):
Beschreibung

Adverse Event - Ongoing with Change: Seriousness Criteria Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0443172
UMLS CUI [1,5]
C0877248
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 Adverse Event

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Adverse Event (Section 1/3)
C0877248 (UMLS CUI-1)
Adverse Event: Form Number
Item
Initial AE Form Number:
text
C1300638 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Adverse Event: Diagnosis
Item
Adverse Event (Diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Start Date
Item
Date of start:
date
C0808070 (UMLS CUI [1])
Adverse Event: Visit Number
Item
Visit Number
float
C1549755 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Adverse Event: Grade
Item
Grade
float
C2985911 (UMLS CUI [1])
Adverse Event: Corrective Treatment
Item
Corrective Treatment/Therapy?
boolean
C0719519 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Adverse Event: Reason
Item
Relationship: Is there a reasonable possibility that the AE was caused by the study treatment?
boolean
C3828190 (UMLS CUI [1])
Action Taken with Cabazitaxel
Item
Action Taken with CABAZITAXEL:
text
C2826626 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
Adverse Event: Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Adverse Event: Recovery Date
Item
If recovered: - Date of recovery:
date
C2004454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Adverse Event: Sequelae
Item
If recovered: - If sequelae, specify:
text
C0243088 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Adverse Event: Seriousness Criteria
Item
Seriousness Criteria
boolean
C0871902 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Adverse Event: Date of Seriousness
Item
If YES: - Date event became serious:
date
C0871902 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0877248 (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])
C0877248 (UMLS CUI [1,3])
Adverse Event: Seriousness Criteria Specification
Code List
If YES: - Complete this section (Tick all criteria that apply):
CL Item
Resulting in death (Resulting in death)
CL Item
Requiring/prolonging hospitalization (Requiring/prolonging hospitalization)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Life threatening (Life threatening)
CL Item
Persistent/significant disablity/incapacity (Persistent/significant disablity/incapacity)
CL Item
Other medically important event (Other medically important event)
Item Group
Adverse Event - Ongoing without Change (Section 2/3) (Section to be completed if NO CHANGE from previous cycle. If there are changes, scroll down and complete the ONGOING WITH CHANGE section 3/3.)
C0549178 (UMLS CUI-1)
C0205360 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Adverse Event - Ongoing without Change: Visit Number
Item
Visit Number
float
C0549178 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1549755 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
Adverse Event - Ongoing without Change
Item
Ongoing without Change
boolean
C0549178 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Item Group
Adverse Event - Ongoing with Change (Section 3/3)
C0549178 (UMLS CUI-1)
C0443172 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Adverse Event - Ongoing with Change: Visit Number
Item
Visit Number
float
C0549178 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C1549755 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
Adverse Event - Ongoing with Change: Grade
Item
Grade
float
C0549178 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C2985911 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
Adverse Event - Ongoing with Change: Corrective Treatment
Item
Corrective Treatment/ Therapy?
boolean
C0719519 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,5])
Adverse Event - Ongoing with Change: Reason
Item
Relationship: Is there a reasonable possibility that the AE was caused by the study treatment?
boolean
C3828190 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
Adverse Event - Ongoing with Change: Action Taken with Cabazitaxel
Item
Action Taken with CABAZITAXEL:
text
C2826626 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,5])
Adverse Event - Ongoing with Change: Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
Adverse Event - Ongoing with Change: Recovery Date
Item
If recovered: - Date of recovery
date
C2004454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,5])
Adverse Event - Ongoing with Change: Sequelae
Item
If recovered: - If sequelae, specify:
text
C0243088 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
Adverse Event - Ongoing with Change: Seriousness Criteria
Item
Seriousness Criteria
boolean
C0871902 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
Adverse Event - Ongoing with Change: Date of Seriousness
Item
If YES: - Date event became serious:
date
C0871902 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,5])
Item
If YES: - Complete this section (Tick all criteria that apply):
text
C0871902 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,5])
Adverse Event - Ongoing with Change: Seriousness Criteria Specification
Code List
If YES: - Complete this section (Tick all criteria that apply):
CL Item
Resulting in death (Resulting in death)
CL Item
Requiring/prolonging hospitalization (Requiring/prolonging hospitalization)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Life threatening (Life threatening)
CL Item
Persistent/significant disablity/incapacity (Persistent/significant disablity/incapacity)
CL Item
Other medically important event (Other medically important event)
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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