ID

22368

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. 5/31/17 5/31/17 -
Uploaded on

May 31, 2017

DOI

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License

Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Overdose

English

CRFs Cabazitaxel Prostate Cancer NCT01308580 Overdose

1 forms  
Overdose
Description

Overdose

Alias
UMLS CUI-1
C4018909
Initial AE Form Number:
Description

Adverse Event Number

Data type

float

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Adverse Event (Diagnosis) (Specify, in the Diagnosis either OVERDOSE INTENTIONAL or OVERDOSE ACCIDENTAL)
Description

Adverse Event Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
Date of Occurence
Description

Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0011008
dd-mmm-yyyy
Visit Number
Description

Visit Number

Data type

float

Alias
UMLS CUI [1]
C1549755
Relationship: Is there reasonable possibiliy that the overdose was caused by the study treatment?
Description

Overdose: Reason

Data type

boolean

Alias
UMLS CUI [1,1]
C4018909
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
Overdose Stop Date
Description

Overdose: Stop Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0806020
dd-mmm-yyyy
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]
C4018909
If YES: - Date event became serious:
Description

Overdose: 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]
C4018909
dd-mmm-yyyy
If YES: - Complete this section (Tick all criteria that apply):
Description

Overdose: Seriousness Criteria Specification

Data type

text

Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C4018909
Is the Overdose Symptomatic?
Description

If YES, please complete a seperate AE form for each symptom.

Data type

boolean

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0231220
Did the patient overdose with CABAZITAXEL:
Description

Overdose: Cabazitaxel

Data type

boolean

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C2830183
Did the patient overdose with OTHER MEDICATION(S)?
Description

Overdose: Medication

Data type

boolean

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0013227
If YES, specify below the Name and Dosing and please complete also the corresponding eCRF:
Description

Overdose: Medication Specificiation

Data type

text

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C2348235
Did the patient Overdose with Other Non Medicamentous Substance(s)?
Description

Overdose: Substance

Data type

boolean

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0439861
If YES, sepcify the Name and Dosing:
Description

Overdose: Substance Specification

Data type

text

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0439861
UMLS CUI [1,3]
C2348235
If the Overdose is intentional, specify
Description

Overdose: Intentional

Data type

text

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C1283828
Measures taken (Tick all that apply)
Description

* If Systemic Corrective Therapy, please complete the corresponding eCRF.

Data type

text

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0079809
If OTHER, specify:
Description

Overdose: Measures Specification

Data type

text

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0079809
UMLS CUI [1,3]
C2348235
Safety Complementary Form
Description

Safety Complementary Form

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

Weight

Data type

float

Measurement units
  • kg
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
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Similar models

CRFs Cabazitaxel Prostate Cancer NCT01308580 Overdose

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Overdose
C4018909 (UMLS CUI-1)
Adverse Event Number
Item
Initial AE Form Number:
float
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse Event Diagnosis
Item
Adverse Event (Diagnosis) (Specify, in the Diagnosis either OVERDOSE INTENTIONAL or OVERDOSE ACCIDENTAL)
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Date
Item
Date of Occurence
date
C0011008 (UMLS CUI [1])
Visit Number
Item
Visit Number
float
C1549755 (UMLS CUI [1])
Overdose: Reason
Item
Relationship: Is there reasonable possibiliy that the overdose was caused by the study treatment?
boolean
C4018909 (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])
Overdose: Stop Date
Item
Overdose Stop Date
date
C4018909 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Overdose Seriousness Criteria
Item
Seriousness Criteria
boolean
C0871902 (UMLS CUI [1,1])
C4018909 (UMLS CUI [1,2])
Overdose: Date of Seriousness
Item
If YES: - Date event became serious:
date
C0871902 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C4018909 (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])
C4018909 (UMLS CUI [1,3])
Overdose: 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)
Overdose: Symptomatic
Item
Is the Overdose Symptomatic?
boolean
C4018909 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Overdose: Cabazitaxel
Item
Did the patient overdose with CABAZITAXEL:
boolean
C4018909 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
Overdose: Medication
Item
Did the patient overdose with OTHER MEDICATION(S)?
boolean
C4018909 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Overdose: Medication Specificiation
Item
If YES, specify below the Name and Dosing and please complete also the corresponding eCRF:
text
C4018909 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Overdose: Substance
Item
Did the patient Overdose with Other Non Medicamentous Substance(s)?
boolean
C4018909 (UMLS CUI [1,1])
C0439861 (UMLS CUI [1,2])
Overdose: Substance Specification
Item
If YES, sepcify the Name and Dosing:
text
C4018909 (UMLS CUI [1,1])
C0439861 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
If the Overdose is intentional, specify
text
C4018909 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
Overdose: Intentional
Code List
If the Overdose is intentional, specify
CL Item
With Suicidal Thoughts (With Suicidal Thoughts)
CL Item
Without Suicidal Thoughts (Without Suicidal Thoughts)
Item
Measures taken (Tick all that apply)
text
C4018909 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
Overdose: Measures
Code List
Measures taken (Tick all that apply)
CL Item
Activated Charcoal (Activated Charcoal)
CL Item
Gastric Lavage/ Induced Vomiting (Gastric Lavage/ Induced Vomiting)
CL Item
Intubation/ Ventilation (Intubation/ Ventilation)
CL Item
Systemic Corrective Therapy* (Systemic Corrective Therapy*)
CL Item
Other (Other)
Overdose: Measures Specification
Item
If OTHER, specify:
text
C4018909 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Safety Complementary Form
C2697885 (UMLS CUI-1)
Weight
Item
1. Demographics Information Weight
float
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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