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Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.

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: NCT01193257
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Orteronel
Drug: Prednisone
Drug: Orteronel Placebo
Enrollment 1099
Recruitment Details Participants took part in the study at 260 investigative sites in North America, Europe, Argentina, Australia, Brazil, Chile, China, Colombia, Israel, Japan, Mexico, New Zealand, Singapore, South Africa, South Korea, and Taiwan from 15 November 2010 to 29 February 2016.
Pre-assignment Details Male participants with a historical diagnosis of metastatic-castration resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy were enrolled in 1 of 2 treatment groups: Orteronel 400 mg + Prednisone 5 mg or Placebo + Prednisone 5 mg.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Period Title: Overall Study
Started 365 734
Treated 363 732
Completed 0 0
Not Completed 365 734
Reason Not Completed
Death             202             391
Study termination by sponsor             0             3
Withdrawal by Subject             26             86
Lost to Follow-up             2             3
Unblinded due to futility             135             251
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone Total
Hide Arm/Group Description Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 365 734 1099
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all subjects who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 365 participants 734 participants 1099 participants
69.4  (7.95) 69.2  (7.82) 69.3  (7.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 365 participants 734 participants 1099 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
365
 100.0%
734
 100.0%
1099
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 365 participants 734 participants 1099 participants
Hispanic or Latino
45
  12.3%
107
  14.6%
152
  13.8%
Not Hispanic or Latino
302
  82.7%
588
  80.1%
890
  81.0%
Unknown or Not Reported
18
   4.9%
39
   5.3%
57
   5.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 365 participants 734 participants 1099 participants
American Indian or Alaska Native 1 4 5
Asian 48 77 125
Black or African American 9 18 27
White 305 620 925
Unknown or Not Reported 1 3 4
Other 1 12 13
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 365 participants 734 participants 1099 participants
Canada 11 21 32
United States 26 54 80
Austria 5 14 19
Belarus 6 4 10
Belgium 1 12 13
Bulgaria 1 3 4
Estonia 3 2 5
Finland 4 7 11
France 35 44 79
Germany 11 35 46
Greece 22 38 60
Hungary 2 7 9
Ireland 3 6 9
Italy 7 14 21
Portugal 8 8 16
Romania 0 12 12
Croatia 0 3 3
Czech Republic 1 1 2
Lithuania 9 22 31
Netherlands 6 12 18
Poland 5 17 22
Russia 2 2 4
Serbia 1 3 4
Slovakia 5 10 15
Spain 16 25 41
Sweden 10 16 26
Switzerland 1 2 3
United Kingdom 32 75 107
Argentina 1 8 9
Australia 28 66 94
Brazil 37 82 119
Chile 5 7 12
China 5 6 11
Colombia 0 4 4
Israel 5 9 14
Japan 17 33 50
Mexico 1 4 5
New Zealand 6 6 12
Singapore 1 1 2
South Africa 4 14 18
Taiwan, Province Of China 7 7 14
Korea, Republic Of 15 18 33
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 365 participants 734 participants 1099 participants
171.33  (7.675) 172.52  (7.156) 172.12  (7.350)
[1]
Measure Description: Height data was available for 1096 participants as follows: n= 364, 732.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 365 participants 734 participants 1099 participants
79.85  (15.183) 82.77  (15.200) 81.80  (15.249)
[1]
Measure Description: Weight data was available for 1098 participants as follows: n= 365, 733.
Body mass index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 365 participants 734 participants 1099 participants
27.14  (4.491) 27.73  (4.370) 27.54  (4.418)
[1]
Measure Description: BMI data was available for 1095 participants as follows: n= 364, 731.
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.
Time Frame Baseline until death (approximately up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Median (95% Confidence Interval)
Unit of Measure: months
15.3
(13.48 to 16.86)
17.1
(15.45 to 18.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Prednisone, Orteronel + Prednisone
Comments Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening ([less than or equal to] <=4, greater than [>] 4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12085
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.875
Confidence Interval (2-Sided) 95%
0.739 to 1.036
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Radiographic Progression-free Survival (rPFS)
Hide Description rPFS was defined as the time from randomization until radiographic disease progression or death due to any cause, whichever occurred first. Radiographic disease progression was defined as the occurrence of 1 or more of the following: The appearance of 2 or more new lesions on radionuclide bone scan as defined by prostate cancer working group (PCWG)2; Should 2 or more new bone lesions be evident at the first assessment (8-week assessment) on treatment, 2 or more additional new lesions must have been evident on a confirmatory assessment at least 6 weeks later; One or more new soft tissue/visceral organ lesions identified by computed tomography (CT)/magnetic resonance imaging (MRI); Progression as defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria.
Time Frame Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Median (95% Confidence Interval)
Unit of Measure: months
5.7
(5.46 to 6.97)
8.3
(7.76 to 8.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Prednisone, Orteronel + Prednisone
Comments Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (<=4, >4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00038
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.760
Confidence Interval (2-Sided) 95%
0.653 to 0.885
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12
Hide Description The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Measure Type: Number
Unit of Measure: percentage of participants
9.9 24.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Prednisone, Orteronel + Prednisone
Comments P-values test for odds ratio equal to 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Pain Response at Week 12
Hide Description Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A greater than or equal to (>=) 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use; or a 25 percent (%) or more reduction in analgesic use from baseline without an increase in worst pain score from baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Measure Type: Number
Unit of Measure: percentage of participants
9.0 12.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Prednisone, Orteronel + Prednisone
Comments P-values test for odds ratio equal to 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12778
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Hide Description [Not Specified]
Time Frame Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 363 732
Measure Type: Number
Unit of Measure: participants
345 719
6.Secondary Outcome
Title Number of Participants With Abnormal Physical Examination Findings
Hide Description [Not Specified]
Time Frame Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 363 732
Measure Type: Number
Unit of Measure: participants
0 1
7.Secondary Outcome
Title Number of Participants With TEAEs Related to Vital Signs
Hide Description [Not Specified]
Time Frame Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 363 732
Measure Type: Number
Unit of Measure: participants
Hypertension 21 83
Hypotension 8 31
Pyrexia 18 51
8.Secondary Outcome
Title Number of Participants With TEAEs Related to Weight
Hide Description [Not Specified]
Time Frame Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 363 732
Measure Type: Number
Unit of Measure: participants
Weight decreased 32 107
Weight increased 7 6
9.Secondary Outcome
Title Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
Hide Description ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period.
Time Frame Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 353 705
Measure Type: Number
Unit of Measure: participants
Baseline: 0; Overall: 0 56 112
Baseline: 0; Overall: 1 70 121
Baseline: 0; Overall: 2 13 47
Baseline: 0; Overall: 3 5 18
Baseline: 0; Overall: 4 1 3
Baseline: 1; Overall: 0 3 10
Baseline: 1; Overall: 1 103 179
Baseline: 1; Overall: 2 53 113
Baseline: 1; Overall: 3 22 39
Baseline: 1; Overall: 4 7 11
Baseline: 2; Overall: 1 0 6
Baseline: 2; Overall: 2 10 25
Baseline: 2; Overall: 3 10 18
Baseline: 2; Overall: 4 0 3
10.Secondary Outcome
Title Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings
Hide Description [Not Specified]
Time Frame Cycle 59 Day 58
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 363 732
Measure Type: Number
Unit of Measure: participants
1 3
11.Secondary Outcome
Title Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel
Hide Description [Not Specified]
Time Frame Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 363 732
Measure Type: Number
Unit of Measure: participants
Digestive enzymes 9 140
Renal function analyses 13 41
Liver function analyses 14 38
Tissue enzyme analyses NEC 16 30
Coagulation and bleeding analyses 1 17
Mineral and electrolyte analyses 5 9
White blood cell analyses 4 8
Carbohydrate tolerance analyses-including diabetes 0 8
Urinary tract function analyses NEC 1 5
Platelet analyses 3 4
Cholesterol analyses 1 4
Red blood cell analyses 2 3
Protein analyses not elsewhere classified (NEC) 0 3
Vascular tests NEC (including blood pressure) 3 2
Adrenal cortex tests 0 2
Metabolism tests NEC 0 2
Skeletal and cardiac muscle analyses 0 2
Triglyceride analyses 0 1
Urinalysis NEC 0 1
Vitamin analyses 0 1
12.Secondary Outcome
Title Percentage of Participants Achieving PSA50 Response at Any Time During the Study
Hide Description The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline.
Time Frame Cycle: 4, 7, 10, 13, 16, 19, 22, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Measure Type: Number
Unit of Measure: participants
Cycle 4 (n= 283; 559) 12.72 32.74
Cycle 7 (n= 163; 403) 18.40 38.21
Cycle 10 (n= 102; 267) 22.55 36.70
Cycle 13 (n= 55; 171) 23.64 40.94
Cycle 16 (n= 34; 107) 23.53 44.86
Cycle 19 (n= 24; 68) 20.83 42.65
Cycle 22 (n= 14; 36) 28.57 52.78
Cycle 25 (n= 8; 16) 25.00 62.50
13.Secondary Outcome
Title Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12
Hide Description The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population where baseline and post-baseline assessments were available. ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 283 559
Measure Type: Number
Unit of Measure: percentage of participants
2.83 9.66
14.Secondary Outcome
Title Percentage of Participants Achieving PSA90 Response at Any Time During the Study
Hide Description The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.
Time Frame Cycle: 7, 10, 13, 16, 19, 22, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population where baseline and post-baseline assessments were available. ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Measure Type: Number
Unit of Measure: percentage of participants
Cycle 7 (n=163; 403) 4.91 14.89
Cycle 10 (n=102; 267) 6.86 14.23
Cycle 13 (n=55; 171) 7.27 15.20
Cycle 16 (n=34; 107) 5.88 19.63
Cycle 19 (n=24; 68) 4.17 23.53
Cycle 22 (n=14; 36) 0.00 27.78
Cycle 25 (n=8; 16) 0.00 43.75
15.Secondary Outcome
Title Best PSA Response at Any Time During the Study
Hide Description The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline. PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.
Time Frame Cycle: 4, 7, 10, 13, 16, 19, 22, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Best PSA response was not evaluated due to change in planned analysis.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Time to PSA Progression
Hide Description Time to PSA progression was defined as time from randomization to a PSA increase of 25% and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, above the baseline PSA.
Time Frame Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Median (95% Confidence Interval)
Unit of Measure: months
2.9
(2.83 to 2.90)
5.5
(4.40 to 5.56)
17.Secondary Outcome
Title Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)
Hide Description A favorable CTC count was defined as less than (<) 5 counts per (/) 7.5 mililiter (mL) in whole blood. An unfavorable CTC count was defined as >=5 counts/7.5 mL in whole blood.
Time Frame Baseline and EOT (Cycle 59 Day 58)
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Hide Analysis Population Description
ITT population where baseline and post-baseline assessments were available. ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 157 267
Measure Type: Number
Unit of Measure: participants
Baseline: Favorable; EOT: Favorable 27 63
Baseline: Favorable; EOT: Unfavorable 30 40
Baseline: Unfavorable; EOT: Favorable 8 23
Baseline: Unfavorable; EOT: Unfavorable 92 141
18.Secondary Outcome
Title Percentage of Participants With Objective Response
Hide Description Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. The overall objective response was defined as a complete response (CR) or partial response (PR). A complete response (CR) was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes.
Time Frame Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
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Hide Analysis Population Description
Response per RECIST-evaluable population was defined as a subset of participants who had measurable disease by RECIST 1.1 at baseline.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 146 280
Measure Type: Number
Unit of Measure: percentage of participants
2.7 17.1
19.Secondary Outcome
Title Time to Pain Progression
Hide Description Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >= 4 with a >= 2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >= 4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <= 3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use.
Time Frame Baseline until EOT visit or until end of short term follow-up, whichever occurred later (approximately up to 4.5 years)
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Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Median (95% Confidence Interval)
Unit of Measure: months
22.0 [1] 
(20.48 to NA)
24.2
(18.24 to 24.20)
[1]
The upper limit was not estimable.
20.Secondary Outcome
Title Time to Pain Response
Hide Description Time to pain response was defined as the time from randomization until first pain response. Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A >= 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. The analysis was performed by Kaplan-Meier method.
Time Frame Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median: No data is reported since median time to pain response was not estimable (that is, not reached) in either treatment group due to low number of events. Confidence interval: Confidence interval was not estimable due to low number of events
21.Secondary Outcome
Title Number of Participants With Best Pain Response
Hide Description Best pain response was evaluated in participants who had a pain response across the entire study were summarized by treatment group. The pain response was defined as a >=2-point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline.
Time Frame Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Measure Type: Number
Unit of Measure: participants
72 166
22.Secondary Outcome
Title Percentage of Participants With Health-related Quality of Life (HRQOL) Response at Week 12
Hide Description The global health status or quality of life (QOL) was measured as the HRQOL response rate at 12 weeks using the 2-item global health status index of the european organization for research and treatment of cancer-quality of life questionnaire-C30 (EORTC QLQ-C30) instrument. HRQOL response was defined as a 17-point increase from the baseline assessment on the QOL index, after the score had been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional, and social), 1 global health status, 3 symptom scales (fatigue, pain, nausea/vomiting) and 6 single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score representing better level of functioning or greater degree of symptoms.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description:
Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
Overall Number of Participants Analyzed 365 734
Measure Type: Number
Unit of Measure: percentage of participants
9.9 8.7
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days (Cycle 59 Day 58) after the last dose of study drug.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Placebo + Prednisone Orteronel + Prednisone
Hide Arm/Group Description Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
All-Cause Mortality
Placebo + Prednisone Orteronel + Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo + Prednisone Orteronel + Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   148/363 (40.77%)   384/732 (52.46%) 
Blood and lymphatic system disorders     
Anaemia  1  9/363 (2.48%)  21/732 (2.87%) 
Thrombocytopenia  1  1/363 (0.28%)  3/732 (0.41%) 
Thrombotic thrombocytopenic purpura  1  0/363 (0.00%)  1/732 (0.14%) 
Disseminated intravascular coagulation  1  1/363 (0.28%)  2/732 (0.27%) 
Anaemia of chronic disease  1  0/363 (0.00%)  1/732 (0.14%) 
Anaemia of malignant disease  1  0/363 (0.00%)  1/732 (0.14%) 
Febrile neutropenia  1  0/363 (0.00%)  1/732 (0.14%) 
Neutropenia  1  0/363 (0.00%)  1/732 (0.14%) 
Lymphadenopathy  1  1/363 (0.28%)  1/732 (0.14%) 
Haemolytic anaemia  1  0/363 (0.00%)  1/732 (0.14%) 
Haemolytic uraemic syndrome  1  0/363 (0.00%)  1/732 (0.14%) 
Cardiac disorders     
Acute myocardial infarction  1  0/363 (0.00%)  5/732 (0.68%) 
Myocardial infarction  1  2/363 (0.55%)  4/732 (0.55%) 
Angina unstable  1  0/363 (0.00%)  2/732 (0.27%) 
Myocardial ischaemia  1  0/363 (0.00%)  2/732 (0.27%) 
Acute coronary syndrome  1  0/363 (0.00%)  1/732 (0.14%) 
Atrial fibrillation  1  2/363 (0.55%)  9/732 (1.23%) 
Atrial flutter  1  0/363 (0.00%)  1/732 (0.14%) 
Supraventricular tachycardia  1  0/363 (0.00%)  1/732 (0.14%) 
Cardiac failure  1  0/363 (0.00%)  5/732 (0.68%) 
Cardiopulmonary failure  1  1/363 (0.28%)  1/732 (0.14%) 
Cardiac failure acute  1  0/363 (0.00%)  1/732 (0.14%) 
Cardiac failure chronic  1  0/363 (0.00%)  1/732 (0.14%) 
Cardiac failure congestive  1  0/363 (0.00%)  1/732 (0.14%) 
Cardio-respiratory arrest  1  0/363 (0.00%)  4/732 (0.55%) 
Cardiac arrest  1  1/363 (0.28%)  3/732 (0.41%) 
Ventricular tachycardia  1  0/363 (0.00%)  1/732 (0.14%) 
Bradycardia  1  0/363 (0.00%)  1/732 (0.14%) 
Tachycardia  1  0/363 (0.00%)  1/732 (0.14%) 
Arrhythmia  1  1/363 (0.28%)  0/732 (0.00%) 
Atrioventricular block complete  1  0/363 (0.00%)  2/732 (0.27%) 
Left ventricular dysfunction  1  1/363 (0.28%)  1/732 (0.14%) 
Aortic valve stenosis  1  0/363 (0.00%)  1/732 (0.14%) 
Mitral valve incompetence  1  0/363 (0.00%)  1/732 (0.14%) 
Cor pulmonale  1  0/363 (0.00%)  1/732 (0.14%) 
Ear and labyrinth disorders     
Vertigo  1  0/363 (0.00%)  3/732 (0.41%) 
Tinnitus  1  0/363 (0.00%)  1/732 (0.14%) 
Vertigo positional  1  0/363 (0.00%)  1/732 (0.14%) 
Endocrine disorders     
Adrenal insufficiency  1  1/363 (0.28%)  3/732 (0.41%) 
Mineralocorticoid deficiency  1  0/363 (0.00%)  1/732 (0.14%) 
Inappropriate antidiuretic hormone secretion  1  0/363 (0.00%)  1/732 (0.14%) 
Hyperthyroidism  1  0/363 (0.00%)  1/732 (0.14%) 
Eye disorders     
Diplopia  1  1/363 (0.28%)  0/732 (0.00%) 
Gastrointestinal disorders     
Vomiting  1  6/363 (1.65%)  18/732 (2.46%) 
Nausea  1  0/363 (0.00%)  13/732 (1.78%) 
Abdominal pain  1  3/363 (0.83%)  10/732 (1.37%) 
Abdominal pain upper  1  0/363 (0.00%)  1/732 (0.14%) 
Abdominal pain lower  1  2/363 (0.55%)  0/732 (0.00%) 
Constipation  1  3/363 (0.83%)  6/732 (0.82%) 
Gastrooesophageal reflux disease  1  0/363 (0.00%)  1/732 (0.14%) 
Pancreatitis  1  0/363 (0.00%)  3/732 (0.41%) 
Pancreatitis acute  1  0/363 (0.00%)  2/732 (0.27%) 
Diarrhoea  1  0/363 (0.00%)  5/732 (0.68%) 
Rectal haemorrhage  1  1/363 (0.28%)  3/732 (0.41%) 
Small intestinal haemorrhage  1  0/363 (0.00%)  1/732 (0.14%) 
Ileus  1  1/363 (0.28%)  1/732 (0.14%) 
Intestinal obstruction  1  1/363 (0.28%)  1/732 (0.14%) 
Subileus  1  0/363 (0.00%)  1/732 (0.14%) 
Colitis  1  0/363 (0.00%)  2/732 (0.27%) 
Colitis ulcerative  1  0/363 (0.00%)  1/732 (0.14%) 
Gastritis  1  0/363 (0.00%)  2/732 (0.27%) 
Gastroduodenitis  1  0/363 (0.00%)  1/732 (0.14%) 
Inguinal hernia  1  0/363 (0.00%)  3/732 (0.41%) 
Haematochezia  1  0/363 (0.00%)  1/732 (0.14%) 
Lower gastrointestinal haemorrhage  1  0/363 (0.00%)  1/732 (0.14%) 
Gastrointestinal haemorrhage  1  2/363 (0.55%)  0/732 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/363 (0.28%)  0/732 (0.00%) 
Oesophageal haemorrhage  1  0/363 (0.00%)  1/732 (0.14%) 
Gastric haemorrhage  1  1/363 (0.28%)  0/732 (0.00%) 
Small intestinal obstruction  1  0/363 (0.00%)  1/732 (0.14%) 
Abdominal distension  1  0/363 (0.00%)  1/732 (0.14%) 
Enterocolitis  1  0/363 (0.00%)  1/732 (0.14%) 
Ileus paralytic  1  0/363 (0.00%)  1/732 (0.14%) 
Retroperitoneal haemorrhage  1  0/363 (0.00%)  1/732 (0.14%) 
Stomatitis  1  0/363 (0.00%)  1/732 (0.14%) 
Gastric ulcer haemorrhage  1  1/363 (0.28%)  0/732 (0.00%) 
Gastritis erosive  1  1/363 (0.28%)  0/732 (0.00%) 
Diverticulitis intestinal haemorrhagic  1  1/363 (0.28%)  0/732 (0.00%) 
Intestinal ischaemia  1  1/363 (0.28%)  0/732 (0.00%) 
Large intestinal obstruction  1  1/363 (0.28%)  0/732 (0.00%) 
General disorders     
General physical health deterioration  1  4/363 (1.10%)  19/732 (2.60%) 
Multi-organ failure  1  0/363 (0.00%)  3/732 (0.41%) 
Disease progression  1  0/363 (0.00%)  2/732 (0.27%) 
Performance status decreased  1  0/363 (0.00%)  1/732 (0.14%) 
Fatigue  1  4/363 (1.10%)  10/732 (1.37%) 
Asthenia  1  3/363 (0.83%)  10/732 (1.37%) 
Malaise  1  1/363 (0.28%)  4/732 (0.55%) 
Pyrexia  1  2/363 (0.55%)  8/732 (1.09%) 
Pain  1  2/363 (0.55%)  3/732 (0.41%) 
Chest pain  1  1/363 (0.28%)  2/732 (0.27%) 
Non-cardiac chest pain  1  0/363 (0.00%)  2/732 (0.27%) 
Spinal pain  1  0/363 (0.00%)  0/732 (0.00%) 
Oedema peripheral  1  0/363 (0.00%)  3/732 (0.41%) 
Generalised oedema  1  0/363 (0.00%)  1/732 (0.14%) 
Death  1  0/363 (0.00%)  1/732 (0.14%) 
Sudden death  1  1/363 (0.28%)  0/732 (0.00%) 
Thrombosis in device  1  1/363 (0.28%)  1/732 (0.14%) 
Device occlusion  1  0/363 (0.00%)  1/732 (0.14%) 
Systemic inflammatory response syndrome  1  0/363 (0.00%)  1/732 (0.14%) 
Drug intolerance  1  0/363 (0.00%)  1/732 (0.14%) 
Gait disturbance  1  1/363 (0.28%)  0/732 (0.00%) 
Cyst  1  1/363 (0.28%)  0/732 (0.00%) 
Hepatobiliary disorders     
Cholestasis  1  0/363 (0.00%)  1/732 (0.14%) 
Jaundice  1  0/363 (0.00%)  1/732 (0.14%) 
Hepatic function abnormal  1  1/363 (0.28%)  1/732 (0.14%) 
Hepatic failure  1  0/363 (0.00%)  1/732 (0.14%) 
Cholelithiasis  1  1/363 (0.28%)  0/732 (0.00%) 
Bile duct stenosis  1  1/363 (0.28%)  0/732 (0.00%) 
Infections and infestations     
Sepsis  1  3/363 (0.83%)  14/732 (1.91%) 
Urosepsis  1  2/363 (0.55%)  12/732 (1.64%) 
Septic shock  1  4/363 (1.10%)  7/732 (0.96%) 
Bacteraemia  1  0/363 (0.00%)  3/732 (0.41%) 
Pneumonia  1  9/363 (2.48%)  19/732 (2.60%) 
Lower respiratory tract infection  1  2/363 (0.55%)  3/732 (0.41%) 
Lung infection  1  1/363 (0.28%)  3/732 (0.41%) 
Bronchopneumonia  1  0/363 (0.00%)  3/732 (0.41%) 
Lobar pneumonia  1  0/363 (0.00%)  3/732 (0.41%) 
Urinary tract infection  1  4/363 (1.10%)  20/732 (2.73%) 
Pyelonephritis  1  0/363 (0.00%)  4/732 (0.55%) 
Pyelonephritis acute  1  0/363 (0.00%)  1/732 (0.14%) 
Pyelonephritis chronic  1  1/363 (0.28%)  0/732 (0.00%) 
Appendicitis  1  1/363 (0.28%)  3/732 (0.41%) 
Gastroenteritis  1  1/363 (0.28%)  2/732 (0.27%) 
Anal abscess  1  0/363 (0.00%)  2/732 (0.27%) 
Abdominal infection  1  0/363 (0.00%)  1/732 (0.14%) 
Diverticulitis  1  0/363 (0.00%)  1/732 (0.14%) 
Peritonitis  1  0/363 (0.00%)  1/732 (0.14%) 
Rectal abscess  1  0/363 (0.00%)  1/732 (0.14%) 
Cellulitis  1  1/363 (0.28%)  5/732 (0.68%) 
Pneumonia bacterial  1  1/363 (0.28%)  1/732 (0.14%) 
Bacterial infection  1  0/363 (0.00%)  1/732 (0.14%) 
Endocarditis bacterial  1  1/363 (0.28%)  0/732 (0.00%) 
Device related infection  1  1/363 (0.28%)  1/732 (0.14%) 
Respiratory tract infection  1  1/363 (0.28%)  1/732 (0.14%) 
Infection  1  0/363 (0.00%)  1/732 (0.14%) 
Pelvic abscess  1  0/363 (0.00%)  1/732 (0.14%) 
Wound infection  1  1/363 (0.28%)  0/732 (0.00%) 
Herpes zoster  1  0/363 (0.00%)  3/732 (0.41%) 
Staphylococcal bacteraemia  1  1/363 (0.28%)  2/732 (0.27%) 
Staphylococcal sepsis  1  1/363 (0.28%)  0/732 (0.00%) 
Abscess oral  1  0/363 (0.00%)  1/732 (0.14%) 
Tooth abscess  1  0/363 (0.00%)  1/732 (0.14%) 
Escherichia bacteraemia  1  0/363 (0.00%)  1/732 (0.14%) 
Escherichia urinary tract infection  1  0/363 (0.00%)  1/732 (0.14%) 
Soft tissue infection  1  0/363 (0.00%)  1/732 (0.14%) 
Subcutaneous abscess  1  0/363 (0.00%)  1/732 (0.14%) 
Erysipelas  1  0/363 (0.00%)  1/732 (0.14%) 
Pneumonia pneumococcal  1  0/363 (0.00%)  1/732 (0.14%) 
Upper respiratory tract infection  1  1/363 (0.28%)  1/732 (0.14%) 
Clostridium difficile colitis  1  0/363 (0.00%)  1/732 (0.14%) 
Fungal oesophagitis  1  0/363 (0.00%)  1/732 (0.14%) 
Proteus infection  1  0/363 (0.00%)  1/732 (0.14%) 
Salmonella sepsis  1  0/363 (0.00%)  1/732 (0.14%) 
Spinal cord infection  1  1/363 (0.28%)  0/732 (0.00%) 
Nosocomial infection  1  1/363 (0.28%)  0/732 (0.00%) 
Listeriosis  1  1/363 (0.28%)  0/732 (0.00%) 
Pulmonary tuberculosis  1  1/363 (0.28%)  0/732 (0.00%) 
Injury, poisoning and procedural complications     
Hip fracture  1  0/363 (0.00%)  3/732 (0.41%) 
Humerus fracture  1  0/363 (0.00%)  3/732 (0.41%) 
Ankle fracture  1  0/363 (0.00%)  1/732 (0.14%) 
Upper limb fracture  1  0/363 (0.00%)  1/732 (0.14%) 
Femoral neck fracture  1  1/363 (0.28%)  0/732 (0.00%) 
Lower limb fracture  1  1/363 (0.28%)  0/732 (0.00%) 
Fall  1  1/363 (0.28%)  3/732 (0.41%) 
Road traffic accident  1  1/363 (0.28%)  0/732 (0.00%) 
Spinal compression fracture  1  1/363 (0.28%)  1/732 (0.14%) 
Cervical vertebral fracture  1  0/363 (0.00%)  1/732 (0.14%) 
Rib fracture  1  1/363 (0.28%)  1/732 (0.14%) 
Subdural haematoma  1  0/363 (0.00%)  1/732 (0.14%) 
Joint dislocation  1  0/363 (0.00%)  1/732 (0.14%) 
Ligament sprain  1  0/363 (0.00%)  1/732 (0.14%) 
Overdose  1  0/363 (0.00%)  1/732 (0.14%) 
Radiation proctitis  1  0/363 (0.00%)  1/732 (0.14%) 
Transfusion-related circulatory overload  1  0/363 (0.00%)  1/732 (0.14%) 
Kidney rupture  1  1/363 (0.28%)  0/732 (0.00%) 
Ankle fracture  1  0/363 (0.00%)  0/732 (0.00%) 
Femoral neck fracture  1  0/363 (0.00%)  0/732 (0.00%) 
Hip fracture  1  0/363 (0.00%)  0/732 (0.00%) 
Lower limb fracture  1  0/363 (0.00%)  0/732 (0.00%) 
Overdose  1  0/363 (0.00%)  0/732 (0.00%) 
Humerus fracture  1  0/363 (0.00%)  0/732 (0.00%) 
Upper limb fracture  1  0/363 (0.00%)  0/732 (0.00%) 
Orthostatic hypotension  1  0/363 (0.00%)  1/732 (0.14%) 
Deep vein thrombosis  1  3/363 (0.83%)  3/732 (0.41%) 
Investigations     
Lipase increased  1  1/363 (0.28%)  12/732 (1.64%) 
Amylase increased  1  1/363 (0.28%)  5/732 (0.68%) 
Pancreatic enzymes increased  1  0/363 (0.00%)  4/732 (0.55%) 
Liver function test abnormal  1  0/363 (0.00%)  3/732 (0.41%) 
Alanine aminotransferase increased  1  0/363 (0.00%)  2/732 (0.27%) 
Aspartate aminotransferase increased  1  0/363 (0.00%)  1/732 (0.14%) 
Gamma-glutamyltransferase increased  1  0/363 (0.00%)  1/732 (0.14%) 
Blood creatinine increased  1  1/363 (0.28%)  2/732 (0.27%) 
International normalised ratio increased  1  0/363 (0.00%)  2/732 (0.27%) 
Blood cortisol decreased  1  0/363 (0.00%)  1/732 (0.14%) 
Blood glucose increased  1  0/363 (0.00%)  1/732 (0.14%) 
Weight decreased  1  0/363 (0.00%)  1/732 (0.14%) 
Platelet count decreased  1  0/363 (0.00%)  1/732 (0.14%) 
Haemoglobin decreased  1  0/363 (0.00%)  1/732 (0.14%) 
Blood alkaline phosphatase increased  1  0/363 (0.00%)  1/732 (0.14%) 
Metabolism and nutrition disorders     
Dehydration  1  1/363 (0.28%)  15/732 (2.05%) 
Hyperkalaemia  1  0/363 (0.00%)  10/732 (1.37%) 
Hypokalaemia  1  0/363 (0.00%)  2/732 (0.27%) 
Hyperglycaemia  1  0/363 (0.00%)  10/732 (1.37%) 
Decreased appetite  1  4/363 (1.10%)  4/732 (0.55%) 
Hypercalcaemia  1  1/363 (0.28%)  2/732 (0.27%) 
Hypocalcaemia  1  0/363 (0.00%)  1/732 (0.14%) 
Diabetes mellitus  1  0/363 (0.00%)  3/732 (0.41%) 
Hyponatraemia  1  1/363 (0.28%)  2/732 (0.27%) 
Diabetic ketoacidosis  1  0/363 (0.00%)  2/732 (0.27%) 
Cachexia  1  0/363 (0.00%)  2/732 (0.27%) 
Hypoglycaemia  1  1/363 (0.28%)  1/732 (0.14%) 
Electrolyte imbalance  1  0/363 (0.00%)  1/732 (0.14%) 
Lactic acidosis  1  0/363 (0.00%)  1/732 (0.14%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/363 (1.10%)  10/732 (1.37%) 
Musculoskeletal pain  1  1/363 (0.28%)  3/732 (0.41%) 
Pain in extremity  1  2/363 (0.55%)  1/732 (0.14%) 
Musculoskeletal chest pain  1  1/363 (0.28%)  0/732 (0.00%) 
Bone pain  1  14/363 (3.86%)  8/732 (1.09%) 
Spinal pain  1  1/363 (0.28%)  1/732 (0.14%) 
Pubic pain  1  0/363 (0.00%)  1/732 (0.14%) 
Pathological fracture  1  1/363 (0.28%)  7/732 (0.96%) 
Osteoporotic fracture  1  0/363 (0.00%)  2/732 (0.27%) 
Arthralgia  1  0/363 (0.00%)  4/732 (0.55%) 
Muscular weakness  1  3/363 (0.83%)  3/732 (0.41%) 
Osteonecrosis of jaw  1  1/363 (0.28%)  3/732 (0.41%) 
Chondrocalcinosis pyrophosphate  1  0/363 (0.00%)  2/732 (0.27%) 
Spinal column stenosis  1  0/363 (0.00%)  2/732 (0.27%) 
Myositis  1  0/363 (0.00%)  1/732 (0.14%) 
Mobility decreased  1  0/363 (0.00%)  1/732 (0.14%) 
Myopathy  1  2/363 (0.55%)  0/732 (0.00%) 
Pathological fracture  1  0/363 (0.00%)  0/732 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer  1  24/363 (6.61%)  33/732 (4.51%) 
Prostate cancer metastatic  1  4/363 (1.10%)  6/732 (0.82%) 
Metastatic pain  1  5/363 (1.38%)  9/732 (1.23%) 
Cancer pain  1  2/363 (0.55%)  5/732 (0.68%) 
Tumour pain  1  1/363 (0.28%)  2/732 (0.27%) 
Metastatic pulmonary embolism  1  0/363 (0.00%)  1/732 (0.14%) 
Metastases to meninges  1  0/363 (0.00%)  2/732 (0.27%) 
Metastases to bone  1  1/363 (0.28%)  1/732 (0.14%) 
Lymphangiosis carcinomatosa  1  0/363 (0.00%)  1/732 (0.14%) 
Metastases to central nervous system  1  0/363 (0.00%)  1/732 (0.14%) 
Metastases to liver  1  0/363 (0.00%)  1/732 (0.14%) 
Metastases to the mediastinum  1  0/363 (0.00%)  1/732 (0.14%) 
Metastases to lung  1  1/363 (0.28%)  0/732 (0.00%) 
Metastases to lymph nodes  1  1/363 (0.28%)  0/732 (0.00%) 
Bone marrow tumour cell infiltration  1  2/363 (0.55%)  1/732 (0.14%) 
Gastric cancer  1  1/363 (0.28%)  1/732 (0.14%) 
Anal cancer recurrent  1  0/363 (0.00%)  1/732 (0.14%) 
Chronic lymphocytic leukaemia  1  0/363 (0.00%)  1/732 (0.14%) 
Metastatic renal cell carcinoma  1  0/363 (0.00%)  1/732 (0.14%) 
Bladder neoplasm  1  0/363 (0.00%)  1/732 (0.14%) 
Neoplasm malignant  1  1/363 (0.28%)  0/732 (0.00%) 
Malignant melanoma  1  1/363 (0.28%)  0/732 (0.00%) 
Squamous cell carcinoma of skin  1  1/363 (0.28%)  0/732 (0.00%) 
Nervous system disorders     
Spinal cord compression  1  9/363 (2.48%)  17/732 (2.32%) 
Cauda equina syndrome  1  1/363 (0.28%)  0/732 (0.00%) 
Nerve root compression  1  1/363 (0.28%)  0/732 (0.00%) 
Syncope  1  2/363 (0.55%)  8/732 (1.09%) 
Lethargy  1  0/363 (0.00%)  1/732 (0.14%) 
Dizziness  1  1/363 (0.28%)  5/732 (0.68%) 
Presyncope  1  1/363 (0.28%)  4/732 (0.55%) 
Paraparesis  1  1/363 (0.28%)  4/732 (0.55%) 
Paraplegia  1  0/363 (0.00%)  1/732 (0.14%) 
Cerebrovascular accident  1  1/363 (0.28%)  1/732 (0.14%) 
Cerebral ischaemia  1  0/363 (0.00%)  1/732 (0.14%) 
Haemorrhagic stroke  1  0/363 (0.00%)  1/732 (0.14%) 
Intraventricular haemorrhage  1  0/363 (0.00%)  1/732 (0.14%) 
Ischaemic stroke  1  0/363 (0.00%)  1/732 (0.14%) 
Central nervous system haemorrhage  1  1/363 (0.28%)  0/732 (0.00%) 
Cerebral haemorrhage  1  1/363 (0.28%)  0/732 (0.00%) 
Vascular encephalopathy  1  0/363 (0.00%)  1/732 (0.14%) 
Vertebrobasilar insufficiency  1  0/363 (0.00%)  1/732 (0.14%) 
Ataxia  1  0/363 (0.00%)  1/732 (0.14%) 
Hepatic encephalopathy  1  0/363 (0.00%)  1/732 (0.14%) 
VIIth nerve paralysis  1  0/363 (0.00%)  1/732 (0.14%) 
Headache  1  0/363 (0.00%)  1/732 (0.14%) 
Sciatica  1  0/363 (0.00%)  1/732 (0.14%) 
Cognitive disorder  1  0/363 (0.00%)  1/732 (0.14%) 
Parkinson's disease  1  0/363 (0.00%)  1/732 (0.14%) 
Transient ischaemic attack  1  0/363 (0.00%)  1/732 (0.14%) 
Tremor  1  0/363 (0.00%)  1/732 (0.14%) 
Seizure  1  1/363 (0.28%)  0/732 (0.00%) 
Neuralgia  1  1/363 (0.28%)  0/732 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/363 (0.28%)  4/732 (0.55%) 
Depression  1  0/363 (0.00%)  2/732 (0.27%) 
Delusion  1  0/363 (0.00%)  1/732 (0.14%) 
Psychotic disorder  1  0/363 (0.00%)  1/732 (0.14%) 
Delirium  1  1/363 (0.28%)  0/732 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  4/363 (1.10%)  12/732 (1.64%) 
Renal failure  1  0/363 (0.00%)  11/732 (1.50%) 
Postrenal failure  1  0/363 (0.00%)  3/732 (0.41%) 
Renal impairment  1  2/363 (0.55%)  2/732 (0.27%) 
Chronic kidney disease  1  0/363 (0.00%)  1/732 (0.14%) 
Urinary retention  1  3/363 (0.83%)  14/732 (1.91%) 
Dysuria  1  0/363 (0.00%)  2/732 (0.27%) 
Urge incontinence  1  0/363 (0.00%)  1/732 (0.14%) 
Micturition urgency  1  1/363 (0.28%)  0/732 (0.00%) 
Haematuria  1  3/363 (0.83%)  9/732 (1.23%) 
Hydronephrosis  1  3/363 (0.83%)  3/732 (0.41%) 
Obstructive uropathy  1  1/363 (0.28%)  0/732 (0.00%) 
Renal disorder  1  1/363 (0.28%)  2/732 (0.27%) 
Azotaemia  1  0/363 (0.00%)  1/732 (0.14%) 
Nephrolithiasis  1  0/363 (0.00%)  1/732 (0.14%) 
Calculus urethral  1  0/363 (0.00%)  1/732 (0.14%) 
Urinary tract obstruction  1  4/363 (1.10%)  0/732 (0.00%) 
Urinoma  1  1/363 (0.28%)  0/732 (0.00%) 
Bladder perforation  1  1/363 (0.28%)  0/732 (0.00%) 
Ureteric rupture  1  1/363 (0.28%)  0/732 (0.00%) 
Reproductive system and breast disorders     
Prostatomegaly  1  0/363 (0.00%)  1/732 (0.14%) 
Pelvic pain  1  0/363 (0.00%)  1/732 (0.14%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  4/363 (1.10%)  20/732 (2.73%) 
Dyspnoea  1  1/363 (0.28%)  8/732 (1.09%) 
Respiratory distress  1  0/363 (0.00%)  1/732 (0.14%) 
Respiratory failure  1  3/363 (0.83%)  7/732 (0.96%) 
Acute respiratory failure  1  1/363 (0.28%)  0/732 (0.00%) 
Pleural effusion  1  0/363 (0.00%)  3/732 (0.41%) 
Pulmonary oedema  1  0/363 (0.00%)  2/732 (0.27%) 
Acute pulmonary oedema  1  0/363 (0.00%)  1/732 (0.14%) 
Alveolitis allergic  1  0/363 (0.00%)  1/732 (0.14%) 
Pneumonitis  1  0/363 (0.00%)  1/732 (0.14%) 
Pleuritic pain  1  0/363 (0.00%)  1/732 (0.14%) 
Pulmonary haemorrhage  1  0/363 (0.00%)  1/732 (0.14%) 
Bronchospasm  1  1/363 (0.28%)  1/732 (0.14%) 
Chronic obstructive pulmonary disease  1  0/363 (0.00%)  1/732 (0.14%) 
Pulmonary arterial hypertension  1  0/363 (0.00%)  1/732 (0.14%) 
Lung disorder  1  0/363 (0.00%)  1/732 (0.14%) 
Haemoptysis  1  1/363 (0.28%)  0/732 (0.00%) 
Flank pain  1  0/363 (0.00%)  1/732 (0.14%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/363 (0.28%)  0/732 (0.00%) 
Vascular disorders     
Hypotension  1  0/363 (0.00%)  3/732 (0.41%) 
Haemorrhage  1  0/363 (0.00%)  2/732 (0.27%) 
Embolism  1  0/363 (0.00%)  1/732 (0.14%) 
Thrombosis  1  0/363 (0.00%)  1/732 (0.14%) 
Hypertension  1  0/363 (0.00%)  2/732 (0.27%) 
Hypertensive crisis  1  0/363 (0.00%)  1/732 (0.14%) 
Lymphoedema  1  0/363 (0.00%)  1/732 (0.14%) 
Phlebitis  1  0/363 (0.00%)  1/732 (0.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + Prednisone Orteronel + Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   341/363 (93.94%)   703/732 (96.04%) 
Blood and lymphatic system disorders     
Anaemia  1  59/363 (16.25%)  103/732 (14.07%) 
Gastrointestinal disorders     
Nausea  1  94/363 (25.90%)  319/732 (43.58%) 
Vomiting  1  60/363 (16.53%)  272/732 (37.16%) 
Constipation  1  64/363 (17.63%)  222/732 (30.33%) 
Diarrhoea  1  54/363 (14.88%)  201/732 (27.46%) 
Abdominal pain  1  21/363 (5.79%)  46/732 (6.28%) 
Dyspepsia  1  13/363 (3.58%)  46/732 (6.28%) 
General disorders     
Fatigue  1  84/363 (23.14%)  223/732 (30.46%) 
Asthenia  1  39/363 (10.74%)  102/732 (13.93%) 
Oedema peripheral  1  45/363 (12.40%)  77/732 (10.52%) 
Pyrexia  1  18/363 (4.96%)  48/732 (6.56%) 
Infections and infestations     
Urinary tract infection  1  24/363 (6.61%)  57/732 (7.79%) 
Investigations     
Weight decreased  1  34/363 (9.37%)  113/732 (15.44%) 
Lipase increased  1  5/363 (1.38%)  113/732 (15.44%) 
Amylase increased  1  5/363 (1.38%)  101/732 (13.80%) 
Blood creatinine increased  1  9/363 (2.48%)  38/732 (5.19%) 
Metabolism and nutrition disorders     
Decreased appetite  1  68/363 (18.73%)  208/732 (28.42%) 
Hypokalaemia  1  14/363 (3.86%)  45/732 (6.15%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  62/363 (17.08%)  139/732 (18.99%) 
Arthralgia  1  55/363 (15.15%)  112/732 (15.30%) 
Bone pain  1  51/363 (14.05%)  89/732 (12.16%) 
Muscle spasms  1  27/363 (7.44%)  110/732 (15.03%) 
Pain in extremity  1  45/363 (12.40%)  86/732 (11.75%) 
Musculoskeletal pain  1  24/363 (6.61%)  57/732 (7.79%) 
Myalgia  1  20/363 (5.51%)  39/732 (5.33%) 
Muscular weakness  1  21/363 (5.79%)  36/732 (4.92%) 
Musculoskeletal chest pain  1  16/363 (4.41%)  39/732 (5.33%) 
Nervous system disorders     
Headache  1  23/363 (6.34%)  76/732 (10.38%) 
Dizziness  1  15/363 (4.13%)  78/732 (10.66%) 
Psychiatric disorders     
Insomnia  1  26/363 (7.16%)  67/732 (9.15%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  21/363 (5.79%)  67/732 (9.15%) 
Cough  1  19/363 (5.23%)  63/732 (8.61%) 
Vascular disorders     
Hypertension  1  22/363 (6.06%)  84/732 (11.48%) 
Hot flush  1  20/363 (5.51%)  63/732 (8.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
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.
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01193257    
Other Study ID Numbers: C21005
2010-018662-23 ( EudraCT Number )
CTR20131423 ( Registry Identifier: SFDA CTR )
0991413212 ( Registry Identifier: TCTIN )
C21005 ( Registry Identifier: NRES )
U1111-1181-8040 ( Registry Identifier: WHO )
First Submitted: August 31, 2010
First Posted: September 1, 2010
Results First Submitted: February 27, 2017
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018