ID

22253

Descrição

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

Palavras-chave

Versões (1)
  1. 26/05/2017 26/05/2017 -
Transferido a

26 de maio de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Adverse Event

Inglês

CRFs Cabazitaxel Prostate Cancer NCT01308580 Adverse Event

1 Formulários  
Adverse Event (Section 1/3)
Descrição

Adverse Event (Section 1/3)

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

Complete with initial AE Form Nuber for previously reported AE.

Tipo de dados

text

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

Adverse Event: Diagnosis

Tipo de dados

text

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

Start Date

Tipo de dados

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0808070
dd-mmm-yyyy
Visit Number
Descrição

Adverse Event: Visit Number

Tipo de dados

float

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

Adverse Event: Grade

Tipo de dados

float

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

Adverse Event: Corrective Treatment

Tipo de dados

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?
Descrição

Adverse Event: Reason

Tipo de dados

boolean

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

Action Taken with Cabazitaxel

Tipo de dados

text

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

Adverse Event: Outcome

Tipo de dados

text

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

Adverse Event: Recovery Date

Tipo de dados

date

Unidades de medida
  • 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:
Descrição

Adverse Event: Sequelae

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0243088
UMLS CUI [1,2]
C0877248
Seriousness Criteria
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C0877248
If YES: - Date event became serious:
Descrição

Adverse Event: Date of Seriousness

Tipo de dados

date

Unidades de medida
  • 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):
Descrição

Adverse Event: Seriousness Criteria Specification

Tipo de dados

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.)
Descrição

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
Descrição

Adverse Event - Ongoing without Change: Visit Number

Tipo de dados

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
Descrição

Adverse Event - Ongoing without Change

Tipo de dados

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)
Descrição

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

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

Adverse Event - Ongoing with Change: Visit Number

Tipo de dados

float

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

Adverse Event - Ongoing with Change: Grade

Tipo de dados

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?
Descrição

Adverse Event - Ongoing with Change: Corrective Treatment

Tipo de dados

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?
Descrição

Adverse Event - Ongoing with Change: Reason

Tipo de dados

boolean

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

Adverse Event - Ongoing with Change: Action Taken with Cabazitaxel

Tipo de dados

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
Descrição

Adverse Event - Ongoing with Change: Outcome

Tipo de dados

text

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

Adverse Event - Ongoing with Change: Recovery Date

Tipo de dados

date

Unidades de medida
  • 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:
Descrição

Adverse Event - Ongoing with Change: Sequelae

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0243088
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0443172
UMLS CUI [1,4]
C0877248
Seriousness Criteria
Descrição

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

Tipo de dados

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:
Descrição

Adverse Event - Ongoing with Change: Date of Seriousness

Tipo de dados

date

Unidades de medida
  • 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):
Descrição

Adverse Event - Ongoing with Change: Seriousness Criteria Specification

Tipo de dados

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
Descrição

Safety Complementary Form

Alias
UMLS CUI-1
C2697885
1. Demographic Information: Weight
Descrição

Weight

Tipo de dados

float

Unidades de medida
  • 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.)
Descrição

Adverse Event: Description

Tipo de dados

text

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

First Date of Administration of Study Treatment

Tipo de dados

date

Unidades de medida
  • 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
Descrição

Date of Last Administration: Prednisone

Tipo de dados

date

Unidades de medida
  • 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
Descrição

Last Intended Dose: Prednisone

Tipo de dados

float

Unidades de medida
  • 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
Descrição

Last Actual Dose: Prednisone

Tipo de dados

float

Unidades de medida
  • 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
Descrição

Date of Last Administration: Cabazitaxel

Tipo de dados

date

Unidades de medida
  • 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
Descrição

Last Intended Dose: Cabazitaxel

Tipo de dados

float

Unidades de medida
  • 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
Descrição

Last Actual Dose: Cabazitaxel

Tipo de dados

float

Unidades de medida
  • 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)
Descrição

Date of Admission

Tipo de dados

date

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

Autopsy Report

Tipo de dados

boolean

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

Corrective Treatment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0719519
UMLS CUI [1,2]
C0087111
Voltar ao início da página

Similar models

CRFs Cabazitaxel Prostate Cancer NCT01308580 Adverse Event

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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