Cabazitaxel Versus the Switch to Alternative AR Targeted... | NCT02379390

ID	Type	Description	Link
U1111-1160-6008	Other Identifier	UTN

Status Module

Description Module

Label	Type	Description	Intervention Names
Cabazitaxel	Experimental	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour along with prednisone 10 mg orally on Day 1 of every treatment cycle (each cycle was of 3 weeks) until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.	Drug: Cabazitaxel XRP6258 Drug: Prednisone
Abiraterone acetate or Enzalutamide	Active Comparator	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally, until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.	Drug: Ezalutamide Drug: Abiraterone acetate Drug: Prednisone

Name	Type	Description	Arm Group Labels	Other Names
Cabazitaxel XRP6258	Drug		Cabazitaxel	Jevtana
Ezalutamide

Measure	Description	Time Frame
Radiographic Progression-Free Survival (rPFS)	rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.	Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)

Measure	Description	Time Frame
Number of Participants With Prostate Specific Antigen (PSA) Response	PSA response was defined as decline of serum PSA from baseline by >= 50 percent (%).	Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)
Progression-free Survival (PFS)

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Diagnosis of histologically or cytologically confirmed prostate adenocarcinoma.
Metastatic disease.
Progressive disease (PD) while receiving AR targeted therapy with abiraterone acetate or enzalutamide within 12 months of treatment initiation (≤12 months) by at least one of the following:
Progression in measurable disease Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Appearance of 2 or more new bone lesions according to Prostate Cancer Working Group 2 (PCWG2).
Rising PSA defined (PCWG2) as at least two consecutive rises in PSA to be documented over a reference value (measure 1) taken at least one week apart.
A PSA value of at least 2 nanogram/milliliter (ng/mL) is required at study entry.
Effective castration (serum testosterone levels ≤0.5 ng/mL).
Prior AR targeted therapy (abiraterone acetate or enzalutamide) must be stopped at least 2 weeks before study treatment.
Signed written informed consent.

Exclusion criteria:

Prior chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago. No further anti-cancer therapy after the previous AR targeted therapy and before inclusion. Prior docetaxel in hormone sensitive setting is allowed if completed >1 year before randomization. Prior immunotherapy is allowed.
Less than 28 days elapsed from prior treatment with immunotherapy, radiotherapy, or surgery to the time of randomization.
Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0) at the time of randomization.
Eastern Cooperative Oncology Group (ECOG) performance status >1.
History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which treatment has been completed ≥5 years ago and from which the patient has been disease-free for ≥5 years.
Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
Acquired immunodeficiency syndrome (AIDS)-related illnesses or known Human immunodeficiency virus (HIV) disease requiring antiretroviral treatment.
Any severe acute or chronic medical condition including uncontrolled diabetes mellitus, severe renal impairment, history of cardiovascular disease (uncontrolled hypertension, arterial thrombotic events in the past 6 months, congestive heart failure, severe or unstable angina pectoris, recent myocardial infraction within last 6 months or uncontrolled cardiac arrhythmia), which could impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.
Participants with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and up to 6 months after the last administered dose. The definition of "effective method of contraception" will be based on the Investigator's judgment.
Known allergies, hypersensitivity or intolerance to prednisone or excipients of abiraterone acetate or enzalutamide. History of hypersensitivity to docetaxel or polysorbate 80.
Known history of mineralocorticoid excess or deficiency (not applicable to participants who have already been treated with abiraterone acetate in first line before inclusion).
History of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain arteriovenous malformation or the use of concomitant medications that may lower the seizure threshold (not applicable to participants who have already been treated with enzalutamide in first line before inclusion).
Unable to swallow a whole tablet or capsule.
Inadequate organ and bone marrow function as evidenced by:
Hemoglobin <10.0 g/dL.
Absolute neutrophil count <1.5 x 10^9/L.
Platelet count <100 x 10^9/L.
Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) >1.5 x Upper limit of normal (ULN).
Total bilirubin >1.0 x ULN.
Potassium <3.5 mmol/L.
Serum albumin <3.0 g/dL.
Child-Pugh Class B and C.
Contraindications to the use of corticosteroid treatment.
Symptomatic peripheral neuropathy grade ≥2 NCI CTCAE v4.0.
Concomitant vaccination with yellow fever vaccine.

The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 840030		Muscle Shoals	Alabama	35661	United States
Investigational Site Number 840024

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cabazitaxel	Participants received Cabazitaxel 25 milligrams per meter square (mg/m^2), intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 milligrams (mg) orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 22, 2016	May 10, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Radiographic Progression-Free Survival (rPFS)

rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.

Planned analysis could not be performed due to early study termination.

Posted

Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Units	Counts
Participants	OG0000 OG0010

Secondary

Number of Participants With Prostate Specific Antigen (PSA) Response

PSA response was defined as decline of serum PSA from baseline by >= 50 percent (%).

Planned analysis could not be performed due to early study termination.

Posted

Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Units	Counts

Secondary

Progression-free Survival (PFS)

PFS: time interval between date of randomization to first documentation of tumor progression as per RECIST 1.1.

Planned analysis could not be performed due to early study termination.

Posted

Baseline upto progression or death due to any cause (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Units	Counts

Secondary

Overall Survival

Overall Survival was defined as the time interval from the date of randomization to the date of death due to any cause.

Planned analysis could not be performed due to early study termination.

Posted

Baseline until death or study cut-off date, whichever was earlier (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Units	Counts

Secondary

Time to PSA Progression

Time to PSA progression was defined as the time interval between the date of randomization and the date of first documented PSA progression as per PCWG2 criteria.

Planned analysis could not be performed due to early study termination.

Posted

Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Units	Counts

Secondary

Number of Participants Achieving Tumor Response

Tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1.

Planned analysis could not be performed due to early study termination.

Posted

Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour along with prednisone 10 mg orally on Day 1 of every treatment cycle (each cycle was of 3 weeks) until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Units	Counts

Secondary

Duration of Tumor Response

Duration of tumor response was defined as the time between the first evaluation at which the tumor response criteria were met and the first documentation of tumor progression.

Planned analysis could not be performed due to early study termination.

Posted

Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Units

Secondary

Pain Response Using Brief Pain Inventory-Short Form (BPI-SF) for Pain Intensity Score

Pain response was analyzed using the brief pain inventory-short form (BPI-SF).

Planned analysis could not be performed due to early study termination.

Posted

Baseline until the end of study (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Units	Counts

Secondary

Time to Pain Progression

Time to pain progression was defined as the time interval between the date of randomization and the date of the first documented pain progression.

Planned analysis could not be performed due to early study termination.

Posted

Baseline until disease progression, start of another anticancer therapy or study cut off, whichever came first (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Secondary

Percentage of Participants With Symptomatic Skeletal Event (SSE)

SSE was the occurrence of a new symptomatic pathological fracture, or the use of external beam radiation to relieve bone pain, or the occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.

Planned analysis could not be performed due to early study termination.

Posted

Baseline until the end of study (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Secondary

Time to Occurrence of Any Symptomatic Skeletal Events (SSE)

Time to SSE was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SSE, whichever is earlier.

Planned analysis could not be performed due to early study termination.

Posted

Baseline up to occurrence of the first event defining a SSE (maximum duration: 1059 days)

ID	Title	Description
OG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
OG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.	4	1	4	3	4
EG001	Enzalutamide or Abiraterone	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.	4	2	4	2	4
EG002	Abiraterone	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.	1	0	1	1	1
EG003	Enzalutamide	Participants received enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.	3	2	3	1	3

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Increased Tendency To Bruise	Blood and lymphatic system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG0030 events0 affected3 at risk
Abdominal Pain	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Lip Pain	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Nausea	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Vomiting	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Asthenia	General disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Fatigue	General disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Oedema Peripheral	General disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Influenza	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Foot Fracture	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Ligament Sprain	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Procedural Pain	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Skin Abrasion	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0021 events1 affected1 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Dizziness	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Neuropathy Peripheral	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Peripheral Sensory Neuropathy	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Somnolence	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Insomnia	Psychiatric disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Mood Swings	Psychiatric disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Haematuria	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG003
Hot Flush	Vascular disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0021 events1 affected1 at risk EG003

ID	Term
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes

ID	Title	Description
BG000	Cabazitaxel	Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
BG001	Abiraterone Acetate or Enzalutamide	Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
BG002	Total	Total of all reporting groups

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancytopenia	Blood and lymphatic system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected4 at risk EG0020 events0 affected1 at risk EG0030 events0 affected3 at risk
Fall	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Humerus Fracture	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Seizure	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003
Haematuria	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected4 at risk EG0020 events0 affected1 at risk EG003

ID	Term
C552428	cabazitaxel
C540278	enzalutamide
D000069501	Abiraterone Acetate
D011241	Prednisone