Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer (FIRSTANA)

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ClinicalTrials.gov Identifier: NCT01308567

Recruitment Status : Completed

First Posted : March 4, 2011

Results First Posted : March 3, 2017

Last Update Posted : June 5, 2019

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Sponsor:

Information provided by (Responsible Party):

Sanofi

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Prostate Cancer
Interventions	Drug: Cabazitaxel (XRP6258) Drug: Docetaxel (XRP6976) Drug: Prednisone
Enrollment	1168

Participant Flow

Recruitment Details	The study was conducted at 159 centers in 25 countries. A total of 1510 participants were screened between 17 May 2011 and 09 September 2015 of whom 1168 participants were randomized and 342 were considered as screen failures.
Pre-assignment Details	A total of 1168 participants randomized in this study. Of these, 21 participants randomized but not treated. These participants were included in intent-to-treat (ITT) population, not in safety population. "Study cut-off date" for outcome measures was up to "primary completion date" (PCD) only. After PCD, only adverse event (AE) data was updated.


Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description	Docetaxel (TXT) 75 mg/m^2 intraveno...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description	Docetaxel (TXT) 75 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Period Title: Overall Study
Started	391 ^[1]	389 ^[1]	388 ^[1]
Treated	388 ^[2]	382 ^[3]	377 ^[4]
Completed	389 ^[5]	385 ^[5]	384 ^[5]
Not Completed	2	4	4
Reason Not Completed
Lost to Follow-up	2	4	4
[1] Randomized [2] For 1 participant, actual treatment received was Cabazitaxel 25 mg/m^2. [3] For 15 participants, actual treatment received was Cabazitaxel 25 mg/m^2. [4] For 2 participants, actual treatment received was Cabazitaxel 20 mg/m^2. [5] Completed participants included those who withdrew treatment consent but were followed for survival.

Baseline Characteristics

Arm/Group Title		Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2	Total
Arm/Group Description		Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...	Total of all reporting groups
Arm/Group Description		Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Total of all reporting groups
Overall Number of Baseline Participants		391	389	388	1168
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	391 participants	389 participants	388 participants	1168 participants
<65 years		123 31.5%	128 32.9%	125 32.2%	376 32.2%
65-74 years		181 46.3%	187 48.1%	182 46.9%	550 47.1%
≥75 years		87 22.3%	74 19.0%	81 20.9%	242 20.7%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	391 participants	389 participants	388 participants	1168 participants
	Female	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Male	391 100.0%	389 100.0%	388 100.0%	1168 100.0%

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	OS was defined as the time interval from the date of randomization to ...
Description	OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.
Time Frame	Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants.


Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed	391	389	388
Median (95% Confidence Interval) Unit of Measure: months
	24.3 (22.18 to 27.60)	24.5 (21.75 to 27.20)	25.2 (22.90 to 26.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 25 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by Eastern Cooperative Oncology Group performance status (ECOG PS) score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7574
	Comments	P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.975
	Confidence Interval	(2-Sided) 95% 0.819 to 1.16
	Estimation Comments	Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 20 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9967
	Comments	P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.009
	Confidence Interval	(2-Sided) 95% 0.85 to 1.197
	Estimation Comments	Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2

2.Secondary Outcome


Title	Progression Free Survival (PFS)
Description	PFS: time interval between date of randomization to date of first occu...
Description	PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.
Time Frame	Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants.


Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed	391	389	388
Median (95% Confidence Interval) Unit of Measure: months
	5.3 (4.86 to 5.78)	4.4 (3.91 to 5.09)	5.1 (4.60 to 5.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 25 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.989
	Confidence Interval	(2-Sided) 95% 0.849 to 1.152
	Estimation Comments	Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 20 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.063
	Confidence Interval	(2-Sided) 95% 0.913 to 1.236
	Estimation Comments	Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2

3.Secondary Outcome


Title	Time to Tumor Progression Free Survival
Description	Time to tumor progression free survival was defined as the time interv...
Description	Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.
Time Frame	Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants.


Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed	391	389	388
Median (95% Confidence Interval) Unit of Measure: months
	12.1 (11.30 to 13.77)	13.4 (11.37 to 14.75)	13.1 (11.66 to 14.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 25 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.958
	Confidence Interval	(2-Sided) 95% 0.785 to 1.17
	Estimation Comments	Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 20 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.916
	Confidence Interval	(2-Sided) 95% 0.75 to 1.118
	Estimation Comments	Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2

4.Secondary Outcome


Title	Percentage of Participants With Overall Objective Tumor Response
Description	Overall objective tumor response was defined as having a partial respo...
Description	Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame	Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population. Number of participants analyzed=participants with measurable disease at baseline and at least one valid post-baseline value analyzed for specified outcome measure.


Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed	175	188	173
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	30.9 (24.0 to 37.7)	32.4 (25.8 to 39.1)	41.6 (34.3 to 49.0)

5.Secondary Outcome


Title	Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)
Description	Time to PSA-PFS: time interval between date of randomization & fir...
Description	Time to PSA-PFS: time interval between date of randomization & first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA <10 ng/mL):(a)in participants with baseline PSA>0 ng/mL&<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.
Time Frame	Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population which included all randomized participants.


Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed	391	389	388
Median (95% Confidence Interval) Unit of Measure: months
	8.3 (7.66 to 9.20)	8.2 (7.43 to 8.90)	9.2 (8.44 to 9.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 25 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.948
	Confidence Interval	(2-Sided) 95% 0.8 to 1.123
	Estimation Comments	Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 20 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.047
	Confidence Interval	(2-Sided) 95% 0.886 to 1.238
	Estimation Comments	Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2

6.Secondary Outcome


Title	Percentage of Participants With PSA Response
Description	PSA response was defined as ≥50% decrease from baseline in serum...
Description	PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.
Time Frame	Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population. Number of participants analyzed=participants with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value for specified outcome measure.


Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed	354	346	342
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	68.4 (63.5 to 73.2)	60.7 (55.5 to 65.8)	68.7 (63.8 to 73.6)

7.Secondary Outcome


Title	Time to Pain Progression Free Survival (Pain PFS)
Description	Time to pain PFS was defined as the time interval between date of rand...
Description	Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.
Time Frame	Baseline until disease progression, death or study cut-off date (maximum duration: 51 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population which included all randomized participants.


Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed	391	389	388
Median (95% Confidence Interval) Unit of Measure: months
	10.1 (8.28 to 11.76)	8.0 (6.90 to 9.66)	7.3 (6.44 to 9.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 25 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.189
	Confidence Interval	(2-Sided) 95% 0.986 to 1.434
	Estimation Comments	Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 20 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.189
	Confidence Interval	(2-Sided) 95% 0.985 to 1.435
	Estimation Comments	Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2

8.Secondary Outcome


Title	Percentage of Participants With Pain Response
Description	Pain response was defined as either a ≥2-point decrease from bas...
Description	Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points.
Time Frame	Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population. Number of participants analyzed=participants with pain score with median PPI >= 2 and/or mean analgesic score >= 10 points at baseline and at least one valid post-baseline value for specified outcome measure.


Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed	81	99	104
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	40.7 (30.0 to 51.4)	42.4 (32.7 to 52.2)	39.4 (30.0 to 48.8)

9.Secondary Outcome


Title	Skeletal Related Events (SRE) Free Survival
Description	SRE free survival was defined as the time interval between the date of...
Description	SRE free survival was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SRE or death due to any cause, whichever was earlier. SRE were assessed by clinical evaluation. Occurrence of SRE was defined as: pathological fracture(s) and/or spinal cord compression; need for bone irradiation, including radioisotopes or bone surgery; and change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the setting of increased pain) to treat bone pain. Analysis was performed by Kaplan-Meier method.
Time Frame	Baseline until occurrence of first SRE or death (maximum duration: 51 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population which included all randomized participants.


Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:	Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed	391	389	388
Median (95% Confidence Interval) Unit of Measure: months
	19.0 (15.24 to 22.44)	19.2 (15.21 to 24.61)	17.1 (14.59 to 20.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 25 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.121
	Confidence Interval	(2-Sided) 95% 0.886 to 1.417
	Estimation Comments	Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel 75 mg/m^2, Cabazitaxel 20 mg/m^2
	Comments	Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.014
	Confidence Interval	(2-Sided) 95% 0.798 to 1.288
	Estimation Comments	Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2

10.Secondary Outcome


Title	Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)
Description	FACT-P was a 39-item participant rated questionnaire that measures the...
Description	FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms.
Time Frame	Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)

Outcome Measure Data

Analysis Population Description

Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, 'number analyzed' = participants with available data for each specified category.


Arm/Group Title		Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:		Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:		Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed		375	370	361
Least Squares Mean (95% Confidence Interval) Unit of Measure: units on a scale
Change at Cycle 1	Number Analyzed	333 participants	323 participants	321 participants
Change at Cycle 1		4.17 (1.3 to 7.05)	7.66 (4.79 to 10.53)	6.93 (3.97 to 9.88)
Change at Cycle 2	Number Analyzed	339 participants	339 participants	323 participants
Change at Cycle 2		5.33 (2.46 to 8.2)	7.15 (4.28 to 10.01)	5.28 (2.32 to 8.24)
Change at Cycle 3	Number Analyzed	330 participants	332 participants	316 participants
Change at Cycle 3		4.94 (2.06 to 7.82)	6.79 (3.93 to 9.66)	4.61 (1.64 to 7.58)
Change at Cycle 4	Number Analyzed	316 participants	323 participants	302 participants
Change at Cycle 4		4.07 (1.17 to 6.96)	5.22 (2.35 to 8.09)	4.01 (1.03 to 6.99)
Change at Cycle 5	Number Analyzed	293 participants	290 participants	283 participants
Change at Cycle 5		4.36 (1.44 to 7.27)	5.16 (2.26 to 8.06)	4.09 (1.09 to 7.08)
Change at Cycle 6	Number Analyzed	272 participants	267 participants	262 participants
Change at Cycle 6		3.46 (0.53 to 6.39)	3.8 (0.88 to 6.73)	3.37 (0.35 to 6.39)
Change at Cycle 7	Number Analyzed	244 participants	246 participants	241 participants
Change at Cycle 7		3.16 (0.2 to 6.12)	3.66 (0.71 to 6.61)	3.42 (0.38 to 6.45)
Change at Cycle 8	Number Analyzed	228 participants	222 participants	225 participants
Change at Cycle 8		2.61 (-0.37 to 5.59)	2.71 (-0.27 to 5.68)	1.67 (-1.39 to 4.73)
Change at Cycle 9	Number Analyzed	174 participants	196 participants	190 participants
Change at Cycle 9		2.2 (-0.87 to 5.27)	2.67 (-0.35 to 5.68)	1.89 (-1.22 to 5.01)
Change at Cycle 10	Number Analyzed	149 participants	164 participants	166 participants
Change at Cycle 10		2.08 (-1.05 to 5.21)	2.09 (-0.99 to 5.18)	1.84 (-1.32 to 5)
Change at Cycle 11	Number Analyzed	101 participants	115 participants	111 participants
Change at Cycle 11		0.15 (-3.18 to 3.47)	3.35 (0.1 to 6.6)	2.68 (-0.67 to 6.02)
Change at Cycle 12	Number Analyzed	83 participants	98 participants	98 participants
Change at Cycle 12		0.52 (-2.94 to 3.97)	3.95 (0.61 to 7.29)	0.63 (-2.78 to 4.05)
Change at Cycle 13	Number Analyzed	58 participants	85 participants	80 participants
Change at Cycle 13		1.79 (-1.94 to 5.53)	2.48 (-0.95 to 5.91)	0.55 (-3 to 4.09)
Change at Cycle 14	Number Analyzed	55 participants	78 participants	71 participants
Change at Cycle 14		-1.78 (-5.56 to 2)	2.2 (-1.29 to 5.69)	-0.42 (-4.06 to 3.21)
Change at Cycle 15	Number Analyzed	44 participants	71 participants	63 participants
Change at Cycle 15		-3.49 (-7.5 to 0.51)	1.74 (-1.82 to 5.3)	1.22 (-2.51 to 4.95)
Change at Cycle 16	Number Analyzed	42 participants	58 participants	58 participants
Change at Cycle 16		-3.83 (-7.89 to 0.23)	1.62 (-2.11 to 5.35)	0.5 (-3.3 to 4.3)
Change at Follow-up 1	Number Analyzed	176 participants	185 participants	175 participants
Change at Follow-up 1		-1.08 (-4.15 to 1.99)	-1.45 (-4.48 to 1.59)	-1.82 (-4.97 to 1.32)
Change at Follow-up 2	Number Analyzed	145 participants	129 participants	133 participants
Change at Follow-up 2		-0.02 (-3.16 to 3.13)	-1.98 (-5.17 to 1.21)	-1.78 (-5.04 to 1.47)
Change at Follow-up 3	Number Analyzed	110 participants	103 participants	101 participants
Change at Follow-up 3		-0.55 (-3.83 to 2.74)	-2.16 (-5.47 to 1.14)	-2.68 (-6.08 to 0.72)
Change at Follow-up 4	Number Analyzed	87 participants	73 participants	81 participants
Change at Follow-up 4		-1.19 (-4.61 to 2.23)	-3.64 (-7.18 to -0.1)	-1.7 (-5.25 to 1.84)
Change at Follow-up 5	Number Analyzed	72 participants	63 participants	76 participants
Change at Follow-up 5		-2.05 (-5.61 to 1.51)	-6.73 (-10.39 to -3.06)	-0.6 (-4.18 to 2.99)
Change at Follow-up 6	Number Analyzed	58 participants	46 participants	57 participants
Change at Follow-up 6		-1.17 (-4.92 to 2.58)	-5.36 (-9.32 to -1.4)	-4.05 (-7.87 to -0.23)

11.Secondary Outcome


Title	Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL
Description	FACT-P was a 39-item participant rated questionnaire that measures the...
Description	FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.
Time Frame	Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description:		Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description:		Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Overall Number of Participants Analyzed		376	371	361
Least Squares Mean (95% Confidence Interval) Unit of Measure: units on a scale
Change at Cycle 1	Number Analyzed	331 participants	324 participants	318 participants
Change at Cycle 1		3.31 (1.05 to 5.58)	6.09 (3.83 to 8.35)	5.76 (3.43 to 8.09)
Change at Cycle 2	Number Analyzed	334 participants	337 participants	318 participants
Change at Cycle 2		4.37 (2.1 to 6.64)	5.96 (3.7 to 8.21)	4.26 (1.92 to 6.59)
Change at Cycle 3	Number Analyzed	325 participants	332 participants	314 participants
Change at Cycle 3		4.31 (2.04 to 6.58)	5.28 (3.02 to 7.53)	3.65 (1.31 to 5.99)
Change at Cycle 4	Number Analyzed	313 participants	321 participants	301 participants
Change at Cycle 4		3.39 (1.11 to 5.67)	4.1 (1.83 to 6.36)	3.2 (0.85 to 5.55)
Change at Cycle 5	Number Analyzed	289 participants	285 participants	282 participants
Change at Cycle 5		3.41 (1.11 to 5.7)	4.05 (1.76 to 6.34)	3.1 (0.74 to 5.46)
Change at Cycle 6	Number Analyzed	270 participants	264 participants	260 participants
Change at Cycle 6		2.76 (0.45 to 5.07)	3.15 (0.85 to 5.46)	2.88 (0.5 to 5.26)
Change at Cycle 7	Number Analyzed	239 participants	241 participants	240 participants
Change at Cycle 7		2.29 (-0.05 to 4.62)	3.14 (0.81 to 5.47)	2.94 (0.54 to 5.34)
Change at Cycle 8	Number Analyzed	223 participants	220 participants	222 participants
Change at Cycle 8		1.67 (-0.69 to 4.02)	2.26 (-0.09 to 4.61)	1.49 (-0.92 to 3.91)
Change at Cycle 9	Number Analyzed	174 participants	192 participants	189 participants
Change at Cycle 9		1.75 (-0.67 to 4.18)	2.15 (-0.24 to 4.53)	1.73 (-0.73 to 4.19)
Change at Cycle 10	Number Analyzed	148 participants	163 participants	163 participants
Change at Cycle 10		1.52 (-0.96 to 4)	1.56 (-0.88 to 3.99)	1.62 (-0.89 to 4.12)
Change at Cycle 11	Number Analyzed	99 participants	115 participants	110 participants
Change at Cycle 11		0.35 (-2.29 to 3)	2.72 (0.15 to 5.3)	2.19 (-0.46 to 4.84)
Change at Cycle 12	Number Analyzed	82 participants	97 participants	98 participants
Change at Cycle 12		1.04 (-1.7 to 3.79)	3.08 (0.43 to 5.73)	0.75 (-1.95 to 3.46)
Change at Cycle 13	Number Analyzed	57 participants	85 participants	81 participants
Change at Cycle 13		2.13 (-0.85 to 5.11)	1.78 (-0.94 to 4.5)	0.82 (-1.98 to 3.62)
Change at Cycle 14	Number Analyzed	54 participants	78 participants	71 participants
Change at Cycle 14		-0.13 (-3.15 to 2.89)	1.59 (-1.18 to 4.36)	-0.07 (-2.95 to 2.81)
Change at Cycle 15	Number Analyzed	44 participants	71 participants	63 participants
Change at Cycle 15		-2.1 (-5.29 to 1.09)	1.29 (-1.53 to 4.11)	1.49 (-1.47 to 4.45)
Change at Cycle 16	Number Analyzed	42 participants	58 participants	57 participants
Change at Cycle 16		-2.26 (-5.49 to 0.97)	1.23 (-1.73 to 4.19)	1.44 (-1.59 to 4.47)
Change at Follow-up 1	Number Analyzed	173 participants	183 participants	171 participants
Change at Follow-up 1		-0.96 (-3.38 to 1.47)	-1.26 (-3.66 to 1.14)	-1.62 (-4.11 to 0.86)
Change at Follow-up 2	Number Analyzed	143 participants	127 participants	132 participants
Change at Follow-up 2		-0.07 (-2.56 to 2.42)	-1.12 (-3.65 to 1.41)	-1.05 (-3.62 to 1.53)
Change at Follow-up 3	Number Analyzed	109 participants	101 participants	99 participants
Change at Follow-up 3		-0.32 (-2.92 to 2.28)	-1.67 (-4.29 to 0.96)	-1.98 (-4.68 to 0.72)
Change at Follow-up 4	Number Analyzed	87 participants	71 participants	81 participants
Change at Follow-up 4		-0.91 (-3.62 to 1.8)	-2.54 (-5.36 to 0.29)	-1.03 (-3.84 to 1.78)
Change at Follow-up 5	Number Analyzed	70 participants	62 participants	76 participants
Change at Follow-up 5		-2.15 (-4.99 to 0.69)	-5.36 (-8.27 to -2.44)	-0.82 (-3.67 to 2.02)
Change at Follow-up 6	Number Analyzed	58 participants	45 participants	55 participants
Change at Follow-up 6		-1.77 (-4.75 to 1.2)	-5.32 (-8.49 to -2.16)	-2.76 (-5.82 to 0.3)

Adverse Events

Time Frame	All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 83 months) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description	Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population, which was randomized participants who received study drug and analyzed according to the treatment actually received.

Arm/Group Title	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
Arm/Group Description	Docetaxel (TXT) 75 mg/m^2 IV infusi...	Cabazitaxel 20 mg/m^2 IV infusion o...	Cabazitaxel 25 mg/m^2 IV infusion o...
Arm/Group Description	Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
All-Cause Mortality
	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	126/387 (32.56%)	127/369 (34.42%)	188/391 (48.08%)
Blood and lymphatic system disorders
Anaemia ^† 1	2/387 (0.52%)	8/369 (2.17%)	5/391 (1.28%)
Disseminated intravascular coagulation ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Febrile neutropenia ^† 1	27/387 (6.98%)	7/369 (1.90%)	40/391 (10.23%)
Leukocytosis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Leukopenia ^† 1	2/387 (0.52%)	1/369 (0.27%)	1/391 (0.26%)
Neutropenia ^† 1	4/387 (1.03%)	4/369 (1.08%)	10/391 (2.56%)
Pancytopenia ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Thrombocytopenia ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Cardiac disorders
Acute coronary syndrome ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Acute myocardial infarction ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Angina pectoris ^† 1	1/387 (0.26%)	1/369 (0.27%)	0/391 (0.00%)
Angina unstable ^† 1	1/387 (0.26%)	1/369 (0.27%)	0/391 (0.00%)
Atrial fibrillation ^† 1	1/387 (0.26%)	2/369 (0.54%)	4/391 (1.02%)
Atrial flutter ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Bundle branch block left ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Cardiac arrest ^† 1	2/387 (0.52%)	0/369 (0.00%)	0/391 (0.00%)
Cardiac failure ^† 1	1/387 (0.26%)	2/369 (0.54%)	1/391 (0.26%)
Coronary artery disease ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Myocardial infarction ^† 1	3/387 (0.78%)	0/369 (0.00%)	2/391 (0.51%)
Eye disorders
Cataract ^† 1	0/387 (0.00%)	1/369 (0.27%)	1/391 (0.26%)
Cataract subcapsular ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Macular fibrosis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	1/387 (0.26%)	3/369 (0.81%)	1/391 (0.26%)
Anal incontinence ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Barrett's oesophagus ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Colitis ^† 1	0/387 (0.00%)	1/369 (0.27%)	4/391 (1.02%)
Colitis ischaemic ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Colitis ulcerative ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Constipation ^† 1	1/387 (0.26%)	2/369 (0.54%)	1/391 (0.26%)
Diarrhoea ^† 1	4/387 (1.03%)	2/369 (0.54%)	10/391 (2.56%)
Diverticular perforation ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Duodenal ulcer ^† 1	2/387 (0.52%)	1/369 (0.27%)	1/391 (0.26%)
Duodenal ulcer haemorrhage ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Dysphagia ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Enterovesical fistula ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Gastric haemorrhage ^† 1	0/387 (0.00%)	2/369 (0.54%)	0/391 (0.00%)
Gastric perforation ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Gastric ulcer ^† 1	1/387 (0.26%)	2/369 (0.54%)	0/391 (0.00%)
Gastric ulcer haemorrhage ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Gastritis ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Gastrointestinal haemorrhage ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Gastrointestinal pain ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Gastrointestinal ulcer haemorrhage ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Gastrointestinal vascular malformation haemorrhagic ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Haematemesis ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Haemorrhagic erosive gastritis ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Haemorrhoids ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Ileus ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Intestinal obstruction ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Large intestinal obstruction ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Large intestine perforation ^† 1	1/387 (0.26%)	1/369 (0.27%)	0/391 (0.00%)
Large intestine polyp ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Mechanical ileus ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Melaena ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Nausea ^† 1	3/387 (0.78%)	1/369 (0.27%)	2/391 (0.51%)
Necrotising colitis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Oesophageal ulcer haemorrhage ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Pancreatitis acute ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Rectal haemorrhage ^† 1	0/387 (0.00%)	2/369 (0.54%)	1/391 (0.26%)
Small intestinal obstruction ^† 1	0/387 (0.00%)	2/369 (0.54%)	0/391 (0.00%)
Upper gastrointestinal haemorrhage ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Vomiting ^† 1	3/387 (0.78%)	2/369 (0.54%)	3/391 (0.77%)
General disorders
Asthenia ^† 1	1/387 (0.26%)	1/369 (0.27%)	1/391 (0.26%)
Chest pain ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Death ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Disease progression ^† 1	1/387 (0.26%)	4/369 (1.08%)	2/391 (0.51%)
Fatigue ^† 1	2/387 (0.52%)	2/369 (0.54%)	0/391 (0.00%)
General physical health deterioration ^† 1	1/387 (0.26%)	1/369 (0.27%)	1/391 (0.26%)
Infusion site extravasation ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Multiple organ dysfunction syndrome ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Oedema ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Oedema peripheral ^† 1	2/387 (0.52%)	1/369 (0.27%)	0/391 (0.00%)
Pain ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Pyrexia ^† 1	2/387 (0.52%)	1/369 (0.27%)	4/391 (1.02%)
Sudden cardiac death ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Sudden death ^† 1	0/387 (0.00%)	2/369 (0.54%)	2/391 (0.51%)
Hepatobiliary disorders
Cholecystitis ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Cholecystitis acute ^† 1	1/387 (0.26%)	1/369 (0.27%)	0/391 (0.00%)
Hepatic function abnormal ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Immune system disorders
Anaphylactic reaction ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Cytokine release syndrome ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Drug hypersensitivity ^† 1	2/387 (0.52%)	0/369 (0.00%)	1/391 (0.26%)
Infections and infestations
Abscess intestinal ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Abscess jaw ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Abscess oral ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Anal abscess ^† 1	0/387 (0.00%)	1/369 (0.27%)	1/391 (0.26%)
Appendicitis ^† 1	1/387 (0.26%)	1/369 (0.27%)	0/391 (0.00%)
Appendicitis perforated ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Bacteraemia ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Cellulitis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Cholecystitis infective ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Clostridium difficile colitis ^† 1	0/387 (0.00%)	0/369 (0.00%)	2/391 (0.51%)
Clostridium difficile infection ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Cystitis ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Device related infection ^† 1	0/387 (0.00%)	2/369 (0.54%)	1/391 (0.26%)
Endocarditis ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Erysipelas ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Gastroenteritis ^† 1	0/387 (0.00%)	2/369 (0.54%)	3/391 (0.77%)
Gastrointestinal infection ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Infection ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Lower respiratory tract infection ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Lung abscess ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Lung infection ^† 1	5/387 (1.29%)	1/369 (0.27%)	3/391 (0.77%)
Mastoiditis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Neutropenic infection ^† 1	12/387 (3.10%)	3/369 (0.81%)	21/391 (5.37%)
Neutropenic sepsis ^† 1	3/387 (0.78%)	1/369 (0.27%)	4/391 (1.02%)
Peritonitis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Pneumonia ^† 1	8/387 (2.07%)	3/369 (0.81%)	12/391 (3.07%)
Post procedural cellulitis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Rectal abscess ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Respiratory tract infection ^† 1	1/387 (0.26%)	1/369 (0.27%)	0/391 (0.00%)
Sepsis ^† 1	1/387 (0.26%)	3/369 (0.81%)	3/391 (0.77%)
Septic shock ^† 1	1/387 (0.26%)	0/369 (0.00%)	3/391 (0.77%)
Skin infection ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Staphylococcal osteomyelitis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Staphylococcal sepsis ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Tracheobronchitis ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Tuberculosis ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Upper respiratory tract infection ^† 1	0/387 (0.00%)	1/369 (0.27%)	1/391 (0.26%)
Urinary tract infection ^† 1	2/387 (0.52%)	9/369 (2.44%)	8/391 (2.05%)
Urosepsis ^† 1	0/387 (0.00%)	1/369 (0.27%)	2/391 (0.51%)
Wound infection ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Injury, poisoning and procedural complications
Accidental overdose ^† 1	0/387 (0.00%)	0/369 (0.00%)	2/391 (0.51%)
Craniocerebral injury ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Cystitis radiation ^† 1	0/387 (0.00%)	0/369 (0.00%)	2/391 (0.51%)
Femur fracture ^† 1	1/387 (0.26%)	1/369 (0.27%)	1/391 (0.26%)
Hand fracture ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Hip fracture ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Recall phenomenon ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Spinal compression fracture ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Subarachnoid haemorrhage ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Toxicity to various agents ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Upper limb fracture ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Wrong drug administered ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Investigations
Alanine aminotransferase increased ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Blood creatinine increased ^† 1	1/387 (0.26%)	1/369 (0.27%)	3/391 (0.77%)
Creatinine renal clearance decreased ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Hepatic enzyme increased ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
International normalised ratio increased ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Neutrophil count decreased ^† 1	1/387 (0.26%)	1/369 (0.27%)	3/391 (0.77%)
White blood cell count decreased ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Metabolism and nutrition disorders
Dehydration ^† 1	0/387 (0.00%)	3/369 (0.81%)	5/391 (1.28%)
Failure to thrive ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Hyperglycaemia ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Hypocalcaemia ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Hypoglycaemia ^† 1	2/387 (0.52%)	0/369 (0.00%)	1/391 (0.26%)
Hypokalaemia ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Hyponatraemia ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Metabolic acidosis ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Back pain ^† 1	2/387 (0.52%)	3/369 (0.81%)	2/391 (0.51%)
Bone pain ^† 1	2/387 (0.52%)	3/369 (0.81%)	1/391 (0.26%)
Flank pain ^† 1	0/387 (0.00%)	1/369 (0.27%)	4/391 (1.02%)
Haemarthrosis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Intervertebral disc degeneration ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Intervertebral disc protrusion ^† 1	2/387 (0.52%)	0/369 (0.00%)	0/391 (0.00%)
Joint effusion ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Musculoskeletal pain ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Neck pain ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Pathological fracture ^† 1	1/387 (0.26%)	3/369 (0.81%)	3/391 (0.77%)
Spinal osteoarthritis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Cancer pain ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Colon cancer ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Colorectal cancer metastatic ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Malignant neoplasm of ampulla of Vater ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Metastases to central nervous system ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Metastases to meninges ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Non-small cell lung cancer ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Prostate cancer metastatic ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Renal cancer ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Sebaceous carcinoma ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Squamous cell carcinoma of skin ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Transitional cell carcinoma ^† 1	0/387 (0.00%)	1/369 (0.27%)	1/391 (0.26%)
Tumour pain ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Urinary tract neoplasm ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Nervous system disorders
Brain oedema ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Cerebellar haemorrhage ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Cerebral haematoma ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Cerebral infarction ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Cerebral ischaemia ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Cerebrovascular accident ^† 1	1/387 (0.26%)	0/369 (0.00%)	2/391 (0.51%)
Coma ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Haemorrhagic stroke ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Ischaemic stroke ^† 1	0/387 (0.00%)	3/369 (0.81%)	0/391 (0.00%)
Leukoencephalopathy ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Movement disorder ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Paraparesis ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Peripheral motor neuropathy ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Presyncope ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Spinal cord compression ^† 1	1/387 (0.26%)	4/369 (1.08%)	0/391 (0.00%)
Syncope ^† 1	1/387 (0.26%)	2/369 (0.54%)	3/391 (0.77%)
Transient ischaemic attack ^† 1	0/387 (0.00%)	3/369 (0.81%)	1/391 (0.26%)
Product Issues
Device issue ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Psychiatric disorders
Confusional state ^† 1	0/387 (0.00%)	1/369 (0.27%)	2/391 (0.51%)
Renal and urinary disorders
Acute kidney injury ^† 1	3/387 (0.78%)	3/369 (0.81%)	1/391 (0.26%)
Bladder obstruction ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Bladder perforation ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Calculus bladder ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Calculus urinary ^† 1	0/387 (0.00%)	1/369 (0.27%)	1/391 (0.26%)
Cystitis glandularis ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Cystitis haemorrhagic ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Cystitis noninfective ^† 1	0/387 (0.00%)	1/369 (0.27%)	1/391 (0.26%)
Haematuria ^† 1	2/387 (0.52%)	10/369 (2.71%)	13/391 (3.32%)
Hydronephrosis ^† 1	1/387 (0.26%)	5/369 (1.36%)	3/391 (0.77%)
Nephrolithiasis ^† 1	0/387 (0.00%)	1/369 (0.27%)	2/391 (0.51%)
Renal colic ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Renal failure ^† 1	0/387 (0.00%)	2/369 (0.54%)	3/391 (0.77%)
Renal impairment ^† 1	0/387 (0.00%)	1/369 (0.27%)	1/391 (0.26%)
Ureteric obstruction ^† 1	1/387 (0.26%)	1/369 (0.27%)	0/391 (0.00%)
Ureteric stenosis ^† 1	0/387 (0.00%)	1/369 (0.27%)	1/391 (0.26%)
Urethral stenosis ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Urethritis noninfective ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Urinary bladder haemorrhage ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Urinary bladder rupture ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Urinary retention ^† 1	0/387 (0.00%)	3/369 (0.81%)	2/391 (0.51%)
Urinary tract obstruction ^† 1	1/387 (0.26%)	6/369 (1.63%)	3/391 (0.77%)
Urinary tract pain ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Reproductive system and breast disorders
Pelvic pain ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Respiratory, thoracic and mediastinal disorders
Aspiration ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Bronchospasm ^† 1	1/387 (0.26%)	0/369 (0.00%)	1/391 (0.26%)
Choking ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Chronic obstructive pulmonary disease ^† 1	2/387 (0.52%)	0/369 (0.00%)	0/391 (0.00%)
Cough ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Dyspnoea ^† 1	1/387 (0.26%)	1/369 (0.27%)	0/391 (0.00%)
Epistaxis ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Hydrothorax ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Interstitial lung disease ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Pleural effusion ^† 1	1/387 (0.26%)	0/369 (0.00%)	2/391 (0.51%)
Pleurisy ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Pneumonia aspiration ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Pneumothorax ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Pulmonary congestion ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Pulmonary embolism ^† 1	3/387 (0.78%)	8/369 (2.17%)	9/391 (2.30%)
Pulmonary oedema ^† 1	2/387 (0.52%)	1/369 (0.27%)	0/391 (0.00%)
Respiratory failure ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Skin and subcutaneous tissue disorders
Diabetic foot ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Vascular disorders
Aortic aneurysm ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Aortic dissection ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Deep vein thrombosis ^† 1	5/387 (1.29%)	2/369 (0.54%)	1/391 (0.26%)
Embolism ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Hypertension ^† 1	1/387 (0.26%)	0/369 (0.00%)	1/391 (0.26%)
Hypertensive crisis ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Hypotension ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Hypovolaemic shock ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Pelvic venous thrombosis ^† 1	0/387 (0.00%)	0/369 (0.00%)	1/391 (0.26%)
Peripheral arterial occlusive disease ^† 1	0/387 (0.00%)	1/369 (0.27%)	0/391 (0.00%)
Peripheral ischaemia ^† 1	1/387 (0.26%)	0/369 (0.00%)	0/391 (0.00%)
Shock ^† 1	1/387 (0.26%)	0/369 (0.00%)	1/391 (0.26%)
Thrombophlebitis ^† 1	0/387 (0.00%)	1/369 (0.27%)	1/391 (0.26%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDra 21.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Docetaxel 75 mg/m^2	Cabazitaxel 20 mg/m^2	Cabazitaxel 25 mg/m^2
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	353/387 (91.21%)	323/369 (87.53%)	354/391 (90.54%)
Blood and lymphatic system disorders
Neutropenia ^† 1	8/387 (2.07%)	11/369 (2.98%)	25/391 (6.39%)
Eye disorders
Lacrimation increased ^† 1	37/387 (9.56%)	8/369 (2.17%)	3/391 (0.77%)
Gastrointestinal disorders
Abdominal pain ^† 1	14/387 (3.62%)	34/369 (9.21%)	33/391 (8.44%)
Constipation ^† 1	69/387 (17.83%)	90/369 (24.39%)	78/391 (19.95%)
Diarrhoea ^† 1	140/387 (36.18%)	120/369 (32.52%)	190/391 (48.59%)
Dyspepsia ^† 1	13/387 (3.36%)	20/369 (5.42%)	15/391 (3.84%)
Nausea ^† 1	86/387 (22.22%)	92/369 (24.93%)	125/391 (31.97%)
Stomatitis ^† 1	53/387 (13.70%)	18/369 (4.88%)	26/391 (6.65%)
Vomiting ^† 1	44/387 (11.37%)	44/369 (11.92%)	75/391 (19.18%)
General disorders
Asthenia ^† 1	94/387 (24.29%)	84/369 (22.76%)	90/391 (23.02%)
Fatigue ^† 1	110/387 (28.42%)	105/369 (28.46%)	126/391 (32.23%)
Oedema peripheral ^† 1	78/387 (20.16%)	36/369 (9.76%)	30/391 (7.67%)
Pyrexia ^† 1	36/387 (9.30%)	22/369 (5.96%)	28/391 (7.16%)
Infections and infestations
Nasopharyngitis ^† 1	25/387 (6.46%)	19/369 (5.15%)	15/391 (3.84%)
Urinary tract infection ^† 1	7/387 (1.81%)	35/369 (9.49%)	33/391 (8.44%)
Injury, poisoning and procedural complications
Incorrect dose administered ^† 1	0/387 (0.00%)	6/369 (1.63%)	30/391 (7.67%)
Investigations
Blood creatinine increased ^† 1	14/387 (3.62%)	27/369 (7.32%)	16/391 (4.09%)
Weight decreased ^† 1	19/387 (4.91%)	17/369 (4.61%)	40/391 (10.23%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	66/387 (17.05%)	50/369 (13.55%)	74/391 (18.93%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	31/387 (8.01%)	34/369 (9.21%)	43/391 (11.00%)
Back pain ^† 1	52/387 (13.44%)	64/369 (17.34%)	55/391 (14.07%)
Bone pain ^† 1	24/387 (6.20%)	31/369 (8.40%)	29/391 (7.42%)
Muscle spasms ^† 1	15/387 (3.88%)	28/369 (7.59%)	13/391 (3.32%)
Myalgia ^† 1	28/387 (7.24%)	22/369 (5.96%)	22/391 (5.63%)
Pain in extremity ^† 1	38/387 (9.82%)	26/369 (7.05%)	19/391 (4.86%)
Nervous system disorders
Dizziness ^† 1	25/387 (6.46%)	27/369 (7.32%)	34/391 (8.70%)
Dysgeusia ^† 1	70/387 (18.09%)	41/369 (11.11%)	59/391 (15.09%)
Headache ^† 1	31/387 (8.01%)	21/369 (5.69%)	27/391 (6.91%)
Paraesthesia ^† 1	24/387 (6.20%)	25/369 (6.78%)	14/391 (3.58%)
Peripheral sensory neuropathy ^† 1	97/387 (25.06%)	43/369 (11.65%)	48/391 (12.28%)
Psychiatric disorders
Insomnia ^† 1	28/387 (7.24%)	24/369 (6.50%)	20/391 (5.12%)
Renal and urinary disorders
Dysuria ^† 1	9/387 (2.33%)	23/369 (6.23%)	21/391 (5.37%)
Haematuria ^† 1	13/387 (3.36%)	69/369 (18.70%)	91/391 (23.27%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	38/387 (9.82%)	26/369 (7.05%)	33/391 (8.44%)
Dyspnoea ^† 1	36/387 (9.30%)	36/369 (9.76%)	32/391 (8.18%)
Epistaxis ^† 1	22/387 (5.68%)	10/369 (2.71%)	17/391 (4.35%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	151/387 (39.02%)	33/369 (8.94%)	51/391 (13.04%)
Nail disorder ^† 1	35/387 (9.04%)	1/369 (0.27%)	3/391 (0.77%)
Rash ^† 1	23/387 (5.94%)	3/369 (0.81%)	5/391 (1.28%)
Vascular disorders
Hypertension ^† 1	16/387 (4.13%)	20/369 (5.42%)	12/391 (3.07%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDra 21.0

Limitations and Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Trial Transparency Team
Organization:	Sanofi
EMail:	Contact-US@sanofi.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.

Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Mace S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.

Oudard S, Fizazi K, Sengelov L, Daugaard G, Saad F, Hansen S, Hjalm-Eriksson M, Jassem J, Thiery-Vuillemin A, Caffo O, Castellano D, Mainwaring PN, Bernard J, Shen L, Chadjaa M, Sartor O. Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA. J Clin Oncol. 2017 Oct 1;35(28):3189-3197. doi: 10.1200/JCO.2016.72.1068. Epub 2017 Jul 28.

de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available.

Layout table for additonal information

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01308567
Other Study ID Numbers:	EFC11784 2010-022064-12 ( EudraCT Number ) U1111-1117-8356 ( Other Identifier: UTN )
First Submitted:	March 3, 2011
First Posted:	March 4, 2011
Results First Submitted:	September 8, 2016
Results First Posted:	March 3, 2017
Last Update Posted:	June 5, 2019

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