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Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide (PRIMCAB)

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ClinicalTrials.gov Identifier: NCT02379390
Recruitment Status : Terminated (Unsatisfactory patient accrual)
First Posted : March 4, 2015
Results First Posted : June 21, 2019
Last Update Posted : June 21, 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 Metastatic
Interventions Drug: Cabazitaxel XRP6258
Drug: Ezalutamide
Drug: Abiraterone acetate
Drug: Prednisone
Enrollment 8
Recruitment Details Study conducted at 6 active centers in United States and Canada. A total of 8 participants were enrolled between 17 June 2015 to 13 Mar 2016. Total 15 participants were screened, out of which 7 were screen failures and 8 were randomized and treated in the study. Study was terminated early due to very low recruitment rate in both countries involved.
Pre-assignment Details Participants were randomized to receive either chemotherapy (cabazitaxel) or antiandrogen receptor targeted therapy (abiraterone or enzalutamide were assigned based on previous Androgen receptor [AR] targeted treatment in which participants previously treated with abiraterone were treated with enzalutamide and vice versa due to resistance).
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description Participants received Cabazitaxel 25 milligrams per meter square (mg/m^2), intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 milligrams (mg) orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment. Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Period Title: Overall Study
Started 4 4
Completed [1] 2 2
Not Completed 2 2
Reason Not Completed
Adverse Event             1             1
Investigator’s decision             1             0
Study Termination             0             1
[1]
Participant with Disease Progression were counted as completed.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide Total
Hide Arm/Group Description Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment. Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment. Total of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
All randomized participants who were exposed to at least one dose of study treatment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  25.0%
0
   0.0%
1
  12.5%
>=65 years
3
  75.0%
4
 100.0%
7
  87.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
4
 100.0%
8
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
 100.0%
4
 100.0%
8
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  25.0%
0
   0.0%
1
  12.5%
White
3
  75.0%
4
 100.0%
7
  87.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Radiographic Progression-Free Survival (rPFS)
Hide Description rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.
Time Frame Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Prostate Specific Antigen (PSA) Response
Hide Description PSA response was defined as decline of serum PSA from baseline by >= 50 percent (%).
Time Frame Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS: time interval between date of randomization to first documentation of tumor progression as per RECIST 1.1.
Time Frame Baseline upto progression or death due to any cause (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival was defined as the time interval from the date of randomization to the date of death due to any cause.
Time Frame Baseline until death or study cut-off date, whichever was earlier (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to PSA Progression
Hide Description Time to PSA progression was defined as the time interval between the date of randomization and the date of first documented PSA progression as per PCWG2 criteria.
Time Frame Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants Achieving Tumor Response
Hide Description Tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1.
Time Frame Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour along with prednisone 10 mg orally on Day 1 of every treatment cycle (each cycle was of 3 weeks) until disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Duration of Tumor Response
Hide Description Duration of tumor response was defined as the time between the first evaluation at which the tumor response criteria were met and the first documentation of tumor progression.
Time Frame Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Pain Response Using Brief Pain Inventory-Short Form (BPI-SF) for Pain Intensity Score
Hide Description Pain response was analyzed using the brief pain inventory-short form (BPI-SF).
Time Frame Baseline until the end of study (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Time to Pain Progression
Hide Description Time to pain progression was defined as the time interval between the date of randomization and the date of the first documented pain progression.
Time Frame Baseline until disease progression, start of another anticancer therapy or study cut off, whichever came first (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Percentage of Participants With Symptomatic Skeletal Event (SSE)
Hide Description SSE was the occurrence of a new symptomatic pathological fracture, or the use of external beam radiation to relieve bone pain, or the occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.
Time Frame Baseline until the end of study (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Time to Occurrence of Any Symptomatic Skeletal Events (SSE)
Hide Description Time to SSE was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SSE, whichever is earlier.
Time Frame Baseline up to occurrence of the first event defining a SSE (maximum duration: 1059 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis could not be performed due to early study termination.
Arm/Group Title Cabazitaxel Abiraterone Acetate or Enzalutamide
Hide Arm/Group Description:
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline until the end of study (maximum duration: 1059 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cabazitaxel Enzalutamide or Abiraterone Abiraterone Enzalutamide
Hide Arm/Group Description Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment. Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment. Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment. Participants received enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant’s refusal of further study treatment.
All-Cause Mortality
Cabazitaxel Enzalutamide or Abiraterone Abiraterone Enzalutamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/4 (0.00%)      0/1 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cabazitaxel Enzalutamide or Abiraterone Abiraterone Enzalutamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      2/4 (50.00%)      0/1 (0.00%)      2/3 (66.67%)    
Blood and lymphatic system disorders         
Pancytopenia  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Injury, poisoning and procedural complications         
Fall  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0
Humerus Fracture  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders         
Seizure  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
Renal and urinary disorders         
Haematuria  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
1
Term from vocabulary, MedDra 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cabazitaxel Enzalutamide or Abiraterone Abiraterone Enzalutamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      2/4 (50.00%)      1/1 (100.00%)      1/3 (33.33%)    
Blood and lymphatic system disorders         
Increased Tendency To Bruise  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders         
Abdominal Pain  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Diarrhoea  1  2/4 (50.00%)  2 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Haematochezia  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Lip Pain  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Nausea  1  1/4 (25.00%)  1 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
Vomiting  1  1/4 (25.00%)  1 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
General disorders         
Asthenia  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Fatigue  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Oedema Peripheral  1  2/4 (50.00%)  2 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations         
Influenza  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
Injury, poisoning and procedural complications         
Fall  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
Foot Fracture  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Ligament Sprain  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
Procedural Pain  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Skin Abrasion  1  1/4 (25.00%)  1 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
Metabolism and nutrition disorders         
Decreased Appetite  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
Hypophosphataemia  1  0/4 (0.00%)  0 1/4 (25.00%)  1 1/1 (100.00%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
Back Pain  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Muscular Weakness  1  2/4 (50.00%)  2 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal Pain  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1
Nervous system disorders         
Dizziness  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Neuropathy Peripheral  1  2/4 (50.00%)  2 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Peripheral Sensory Neuropathy  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Somnolence  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Psychiatric disorders         
Insomnia  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Mood Swings  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Renal and urinary disorders         
Haematuria  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders         
Alopecia  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders         
Hot Flush  1  0/4 (0.00%)  0 1/4 (25.00%)  1 1/1 (100.00%)  1 0/3 (0.00%)  0
1
Term from vocabulary, MedDra 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1
EMail: Us@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02379390     History of Changes
Other Study ID Numbers: LPS14022
U1111-1160-6008 ( Other Identifier: UTN )
First Submitted: February 27, 2015
First Posted: March 4, 2015
Results First Submitted: May 10, 2019
Results First Posted: June 21, 2019
Last Update Posted: June 21, 2019