Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01308567
Recruitment Status : Completed
First Posted : March 4, 2011
Results First Posted : March 3, 2017
Last Update Posted : June 5, 2019
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
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
Hide 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.
Arm/Group Title Docetaxel 75 mg/m^2 Cabazitaxel 20 mg/m^2 Cabazitaxel 25 mg/m^2 Total
Hide 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
Hide 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%
1.Primary Outcome
Title Overall Survival (OS)
Hide 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 )
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Show Statistical Analysis 2 Hide 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Show Statistical Analysis 2 Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Show Statistical Analysis 2 Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Show Statistical Analysis 2 Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Show Statistical Analysis 2 Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Show Statistical Analysis 2 Hide 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
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
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
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
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
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
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
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
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
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
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
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
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
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
-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
-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
-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
-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
-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
-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
-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
-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
-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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
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
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
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
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
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
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
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
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
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
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
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
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
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
-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
-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
-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
-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
-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
-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
-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
-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
-1.77
(-4.75 to 1.2)
-5.32
(-8.49 to -2.16)
-2.76
(-5.82 to 0.3)
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
Hide 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   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01308567     History of Changes
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