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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 11 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 11

- 24/05/2017 - 1 Formulaire, 22 Groupes Item, 135 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 10 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 10

- 24/05/2017 - 1 Formulaire, 22 Groupes Item, 135 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 9 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 9

- 24/05/2017 - 1 Formulaire, 22 Groupes Item, 135 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 8 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 8

- 24/05/2017 - 1 Formulaire, 22 Groupes Item, 135 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 7 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 7

- 24/05/2017 - 1 Formulaire, 22 Groupes Item, 135 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 6 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 6

- 24/05/2017 - 1 Formulaire, 22 Groupes Item, 139 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 5 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 5

- 24/05/2017 - 1 Formulaire, 22 Groupes Item, 135 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 4 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 4

- 24/05/2017 - 1 Formulaire, 23 Groupes Item, 136 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Circulating free plasma DNA - Blood Sampling, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 2 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 2

- 18/05/2017 - 1 Formulaire, 24 Groupes Item, 139 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, ECG, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Circulating free plasma DNA - Blood Sampling, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 3 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 3

- 18/05/2017 - 1 Formulaire, 22 Groupes Item, 135 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 1 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 1

- 18/05/2017 - 1 Formulaire, 24 Groupes Item, 142 Eléments de données, 1 Langue
Groupes Item: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Cabazitaxel Pharmacokinetic - Blood Sampling, Cabazitaxel Pharmacogenomic - Blood Sampling, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
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

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