Study in Japan and Ex-Japan to Characterize the Pharmacok... | NCT01666314 | Trialant
NCT01666314
Sponsor
Millennium Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Mar 20, 2018Actual
Enrollment
137Actual
Phase
Phase 1Phase 2
Conditions
Prostate Cancer
Interventions
Orteronel
Orteronel Placebo
Prednisone
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01666314
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C21013
Secondary IDs
ID
Type
Description
Link
2012-001539-30
EudraCT Number
U1111-1179-5750
Other Identifier
WHO
Brief Title
Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
Official Title
A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Patients With Castration-Resistant Prostate Cancer
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Feb 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 20, 2012Actual
Primary Completion Date
Sep 12, 2013Actual
Completion Date
Sep 1, 2016Actual
First Submitted Date
Aug 6, 2012
First Submission Date that Met QC Criteria
Aug 10, 2012
First Posted Date
Aug 16, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 21, 2018
Results First Submitted that Met QC Criteria
Feb 19, 2018
Results First Posted Date
Mar 20, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 28, 2016
Certification/Extension First Submitted that Passed QC Review
Mar 28, 2016
Certification/Extension First Posted Date
Apr 29, 2016Estimated
Last Update Submitted Date
Feb 19, 2018
Last Update Posted Date
Mar 20, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Millennium Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
Detailed Description
The drug being tested in this study is called orteronel. Orteronel is being tested to treat adult males who have adenocarcinoma of the prostate. This study will look at the pharmacokinetics (how the drug moves through the body) and pharmacodynamics (how the drug effects the body) in people who take orteronel in addition to prednisone.
The study will enroll approximately 144 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the eight treatment groups (4 in Japan, 4 in Ex-Japan) which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
In Japan:
Participants were randomized in a ratio of 2:1:2:1
200 mg orteronel or Placebo-matching orteronel [(dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient] twice daily (BID) + prednisone
300 mg orteronel, or Placebo-matching orteronel, BID + prednisone Ex-Japan Participants were randomized in a ratio of 2:1:2:1
200 mg orteronel or Placebo-matching orteronel, BID in Cycle 1 + prednisone
400 mg orteronel, or Placebo-matching orteronel ,BID in Cycle 1 + Prednisone
Participants initially randomized to placebo received 4 weeks of placebo and then 12 weeks of active treatment with orteronel then entered a follow-up period treatment period. Participants initially randomized to orteronel received 16 weeks of treatment then entered a follow-up treatment period.
This multi-centre trial will be conducted worldwide. The overall time to participate in this study is approximately 3.2 years. Participants will make multiple visits to the clinic and a final visit 30 to 40 days after receiving their last dose of study drug for a follow-up assessment.
Conditions Module
Conditions
Prostate Cancer
Keywords
castrate resistant prostate cancer,
CRPC,
orteronel,
TAK-700
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
137Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo + Orteronel 200 mg (Japan)
Other
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Drug: Orteronel
Drug: Orteronel Placebo
Drug: Prednisone
Orteronel 200 mg (Japan)
Experimental
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Drug: Orteronel
Drug: Prednisone
Placebo + Orteronel 300 mg (Japan)
Other
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Drug: Orteronel
Drug: Orteronel Placebo
Drug: Prednisone
Orteronel 300 mg (Japan)
Experimental
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Orteronel
Drug
Orteronel tablets
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg (Japan)
Orteronel 300 mg (Japan)
Orteronel 400 mg (Ex-Japan)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Baseline and Week 4
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Baseline and Week 4
Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male participants 18 years or older
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
Prior surgical castration or concurrent use of an agent for medical castration [e.g. Gonadotropin-releasing hormone (GnRH) analogue]
Prostate-Specific Antigen (PSA) ≥ 2 ng/mL at screening
Progressive disease based on PSA and/or radiographic criteria
Exclusion Criteria:
Prior therapy with orteronel, ketoconazole, aminoglutethimide, or abiraterone.
Known hypersensitivity to compounds related to orteronel, orteronel excipients, prednisone (or commercially available equivalent), or GnRH analogue.
All antiandrogen therapy (including bicalutamide) is excluded within 4 weeks before the first dose of study drug. Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5- alpha reductase inhibitors (e.g., finasteride or dutasteride), must be discontinued 2 weeks before the first dose of study drug.
Continuous daily use of oral prednisone (or commercially available equivalent), oral dexamethasone, or other systemic corticosteroids for more than 2 weeks within the 3 months before screening (inhaled, nasal, and local steroids [e.g., joint injection] are allowed).
Prior chemotherapy for prostate cancer, with the exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years before screening.
Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
Accepts Healthy Volunteers
No
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Monitor
Millennium Pharmaceuticals, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Urology Cancer Center, PC
Omaha
Nebraska
68130
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Male participants with a diagnosis of adenocarcinoma of the prostate were enrolled in the study. In Japan, participants were randomized to 200 mg orteronel, Placebo, 300 mg orteronel, or Placebo, BID, in a ratio of 2:1:2:1; ex-Japan participants were randomized to 200 mg orteronel, Placebo, 400 mg orteronel, or Placebo, BID, in a ratio of 2:1:2:1.
Recruitment Details
Participants took part in the study at 43 investigative sites in Japan, United States, Greece, Australia, Netherlands, Ireland and United Kingdom from 20 August 2012 to 01 September 2016.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo + Orteronel 200 mg (Japan)
Orteronel placebo-matching tablets or Orteronel 200 mg, tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years.
Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Drug: Orteronel
Orteronel 200 mg (Ex-Japan)
Experimental
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Drug: Orteronel
Drug: Prednisone
Placebo + Orteronel 400 mg (Ex-Japan)
Other
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Drug: Orteronel
Drug: Orteronel Placebo
Drug: Prednisone
Orteronel 400 mg (Ex-Japan)
Experimental
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Drug: Orteronel
Drug: Prednisone
Placebo + Orteronel 200 mg (Ex-Japan)
Placebo + Orteronel 200 mg (Japan)
Placebo + Orteronel 300 mg (Japan)
Placebo + Orteronel 400 mg (Ex-Japan)
Orteronel Placebo
Drug
Orteronel placebo-matching tablets
Placebo + Orteronel 200 mg (Japan)
Placebo + Orteronel 300 mg (Japan)
Placebo + Orteronel 400 mg (Ex-Japan)
Prednisone
Drug
Prednisone 5 mg
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg (Japan)
Orteronel 300 mg (Japan)
Orteronel 400 mg (Ex-Japan)
Placebo + Orteronel 200 mg (Japan)
Placebo + Orteronel 300 mg (Japan)
Placebo + Orteronel 400 mg (Ex-Japan)
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Baseline and Week 4
Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Baseline and Week 12
Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Baseline and Week 4
Percentage of Participants With PSA50 After 12 Weeks of Treatment
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Baseline and Week 12
Absolute Values for Testosterone
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Adrenocorticotropic Hormone (ACTH)
Serum ACTH was measured by immunometric assay at the central laboratory.
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Corticosterone
Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Cortisol
Serum Cortisol was measured by immunometric assay at the central laboratory.
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Prostate-Specific Antigen (PSA)
Serum PSA was measured at the central laboratory.
Baseline and Cycle 2 Day 1
Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite
Observed predose plasma concentration at steady state.
Cycle 1 Day 8 Predose
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years
FG001
Placebo + Orteronel 300 mg (Japan)
Orteronel placebo-matching tablets or Orteronel 300 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
FG002
Placebo + Orteronel 200 mg (Ex-Japan)
Orteronel placebo-matching tablets, or Orteronel 200 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
FG003
Placebo + Orteronel 400 mg (Ex-Japan)
Orteronel placebo-matching tablets, or Orteronel 400 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
FG00033 subjects
FG00132 subjects
FG00236 subjects
FG00336 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00033 subjects
FG00132 subjects
FG00236 subjects
FG00336 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG00113 subjects
FG0027 subjects
FG0037 subjects
Progressive Disease
FG00011 subjects
FG0019 subjects
FG00219 subjects
FG00320 subjects
Symptomatic Deterioration
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Unsatisfactory Therapeutic Response
FG0007 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
Reason not Specified
FG00010 subjects
FG0017 subjects
FG0025 subjects
FG0035 subjects
Data for baseline characteristics has been summarized as per the treatment received in Cycle 1.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo + Orteronel 200 mg (Japan)
Orteronel placebo-matching tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.
BG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
BG002
Placebo + Orteronel 300 mg (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
BG003
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
BG004
Placebo + Orteronel 200 mg (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
BG005
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
BG006
Placebo + Orteronel 400 mg (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
BG007
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG00122
BG00210
BG00322
BG00411
BG00525
BG00612
BG00724
BG008137
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00072.1(62 to 84)
BG00168.5(52 to 82)
BG00270.1(59 to 76)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Japan
Title
Measurements
BG00011
BG00122
BG002
Height
Mean
Full Range
cm
Title
Denominators
Categories
Title
Measurements
BG000161.94(153.0 to 168.2)
BG001167.10(154.0 to 177.5)
BG002
Weight
Mean
Full Range
kg
Title
Denominators
Categories
Title
Measurements
BG00065.82(55.1 to 82.4)
BG00170.32(47.5 to 85.2)
BG002
Body Mass Index (BMI)
Mean
Full Range
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00025.05(20.6 to 30.4)
BG00125.21(17.8 to 31.2)
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 4
ID
Title
Description
OG000
Placebo (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00021
OG00122
Title
Denominators
Categories
Title
Measurements
OG00086.0(63.7 to 97.0)
OG001100.0(84.6 to 100.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
0.1078
2-Sided
Superiority or Other
Secondary
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 4
ID
Title
Description
OG000
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
Secondary
Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.
Posted
Mean
Standard Deviation
percent change
Baseline and Week 4
ID
Title
Description
OG000
Placebo (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.
Posted
Mean
Standard Deviation
percent change
Baseline and Week 12
ID
Title
Description
OG000
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 4
ID
Title
Description
OG000
Placebo (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Percentage of Participants With PSA50 After 12 Weeks of Treatment
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Absolute Values for Testosterone
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Posted
Mean
Standard Deviation
ng/dL
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
ID
Title
Description
OG000
Placebo (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.
Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Posted
Mean
Standard Deviation
nmol/L
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
ID
Title
Description
OG000
Placebo (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Absolute Values for Adrenocorticotropic Hormone (ACTH)
Serum ACTH was measured by immunometric assay at the central laboratory.
Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Posted
Mean
Standard Deviation
pmol/L
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
ID
Title
Description
OG000
Placebo (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Absolute Values for Corticosterone
Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.
Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Posted
Mean
Standard Deviation
nmol/L
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
ID
Title
Description
OG000
Placebo (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Absolute Values for Cortisol
Serum Cortisol was measured by immunometric assay at the central laboratory.
Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Posted
Mean
Standard Deviation
nmol/L
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
ID
Title
Description
OG000
Placebo (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Absolute Values for Prostate-Specific Antigen (PSA)
Serum PSA was measured at the central laboratory.
Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Posted
Mean
Standard Deviation
ng/mL
Baseline and Cycle 2 Day 1
ID
Title
Description
OG000
Placebo (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite
AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.
Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite
Cumulative amount of urine excreted time 0 to 24 hour.
Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite
Maximum observed steady-state plasma concentration during a dosing interval.
Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.
Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Rac: Accumulation Index for Orteronel and M-I Metabolite
Rac was calculated as the ratio of AUCtau to AUC12hr.
Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite
Observed predose plasma concentration at steady state.
Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 8 Predose
ID
Title
Description
OG000
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG001
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Safety Population included all randomized participants who received at least one dose of study drug. Adverse events are summarized as per the treatment received.
Posted
Number
participants
From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years
ID
Title
Description
OG000
Placebo (Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Time Frame
From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
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. Adverse events were summarized as per the treatment received.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
10
44
44
44
EG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
8
33
33
33
EG002
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
18
32
32
32
EG003
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
16
36
35
36
EG004
Orteronel 400mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
12
36
36
36
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected32 at risk
EG0030 events0 affected36 at risk
EG0040 events0 affected36 at risk
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0011 events1 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected44 at risk
EG0010 events0 affected33 at risk
EG0023 events2 affected32 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Influenza
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Renal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Liver function test abnormal
Investigations
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0002 events1 affected44 at risk
EG0011 events1 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Cardiac disorder
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
General physical health deterioration
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events1 affected32 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Septic shock
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Asthenia
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Fatigue
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Device occlusion
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Hypertension
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Dermatitis exfoliative
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Vomitting
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Sepsis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Lung Neoplasm Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Thoracic Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Facial Bones Fracture
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Coronary Artery Stenosis
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Bile Duct Stone
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Spinal Ligament Ossification
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Lumbar Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Altered State Of Consciousness
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Cataract
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Device Related Infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Gastrointestinal Angiodysplasia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Parkinsonism
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Orthostatic Hypotension
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Pancreatic Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Metastatic Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Pathological Fracture
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lipase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG00036 events19 affected44 at risk
EG00146 events25 affected33 at risk
EG00232 events19 affected32 at risk
EG00310 events9 affected36 at risk
EG0049 events7 affected36 at risk
Amylase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG00021 events16 affected44 at risk
EG00135 events21 affected33 at risk
EG00227 events19 affected32 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0007 events7 affected44 at risk
EG0019 events8 affected33 at risk
EG00212 events10 affected32 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG00012 events11 affected44 at risk
EG0014 events4 affected33 at risk
EG0026 events5 affected32 at risk
EG003
Fatigue
General disorders
MedDRA (16.0)
Systematic Assessment
EG0009 events8 affected44 at risk
EG0010 events0 affected33 at risk
EG0023 events2 affected32 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG00016 events11 affected44 at risk
EG0013 events3 affected33 at risk
EG0029 events8 affected32 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG00012 events7 affected44 at risk
EG0016 events5 affected33 at risk
EG00210 events7 affected32 at risk
EG003
Hot flush
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0007 events7 affected44 at risk
EG0013 events3 affected33 at risk
EG0025 events5 affected32 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0005 events5 affected44 at risk
EG00110 events9 affected33 at risk
EG0028 events6 affected32 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0007 events6 affected44 at risk
EG0017 events7 affected33 at risk
EG00211 events7 affected32 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0008 events6 affected44 at risk
EG0017 events7 affected33 at risk
EG00211 events7 affected32 at risk
EG003
Oedema peripheral
General disorders
MedDRA (16.0)
Systematic Assessment
EG0004 events4 affected44 at risk
EG00110 events8 affected33 at risk
EG0027 events6 affected32 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0007 events5 affected44 at risk
EG0011 events1 affected33 at risk
EG0028 events5 affected32 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0006 events6 affected44 at risk
EG0016 events5 affected33 at risk
EG00214 events8 affected32 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0003 events3 affected44 at risk
EG0014 events4 affected33 at risk
EG00211 events3 affected32 at risk
EG003
Weight decreased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0005 events5 affected44 at risk
EG0012 events2 affected33 at risk
EG0029 events6 affected32 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0003 events3 affected44 at risk
EG0012 events2 affected33 at risk
EG0024 events4 affected32 at risk
EG003
Hypertension
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0004 events4 affected44 at risk
EG0013 events3 affected33 at risk
EG0023 events3 affected32 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0007 events7 affected44 at risk
EG00110 events8 affected33 at risk
EG00213 events8 affected32 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0005 events5 affected44 at risk
EG0018 events8 affected33 at risk
EG0024 events4 affected32 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected44 at risk
EG0012 events2 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Upper respiratory trat infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0004 events4 affected44 at risk
EG0014 events3 affected33 at risk
EG0025 events4 affected32 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0012 events2 affected33 at risk
EG0025 events4 affected32 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0004 events4 affected44 at risk
EG0014 events4 affected33 at risk
EG0023 events2 affected32 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0011 events1 affected33 at risk
EG0023 events2 affected32 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0003 events3 affected44 at risk
EG0012 events2 affected33 at risk
EG0023 events3 affected32 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0004 events4 affected44 at risk
EG0013 events2 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Malaise
General disorders
MedDRA (16.0)
Systematic Assessment
EG0005 events4 affected44 at risk
EG0015 events4 affected33 at risk
EG0027 events6 affected32 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected44 at risk
EG0010 events0 affected33 at risk
EG0025 events5 affected32 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected44 at risk
EG0014 events3 affected33 at risk
EG0028 events5 affected32 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected44 at risk
EG0012 events2 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0003 events2 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0011 events1 affected33 at risk
EG0027 events6 affected32 at risk
EG003
Blood urea increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0002 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0028 events4 affected32 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0023 events3 affected32 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0003 events3 affected44 at risk
EG0011 events1 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0003 events3 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0014 events3 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0004 events4 affected44 at risk
EG0012 events2 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected44 at risk
EG0011 events1 affected33 at risk
EG0024 events3 affected32 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0011 events1 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0024 events3 affected32 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected44 at risk
EG0012 events2 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0013 events3 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0004 events3 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Depression
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected33 at risk
EG0024 events3 affected32 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected44 at risk
EG0011 events1 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0016 events5 affected33 at risk
EG0020 events0 affected32 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0005 events3 affected44 at risk
EG0014 events3 affected33 at risk
EG0025 events3 affected32 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0013 events3 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Cataract
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0013 events3 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0013 events3 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Chronic Gastritis
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0013 events2 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0023 events2 affected32 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Face Oedema
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0023 events2 affected32 at risk
EG003
Pyrexia
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0024 events3 affected32 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0023 events2 affected32 at risk
EG003
Cystitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0013 events3 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Influenza
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0023 events3 affected32 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0014 events2 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Weight increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0014 events4 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0014 events3 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0021 events1 affected32 at risk
EG003
White blood cell count increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Headache
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0021 events1 affected32 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0013 events3 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0024 events3 affected32 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Haemorrhage subcutaneous
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected32 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Glaucoma
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Peripheral swelling
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Metastatic pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Syncope
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Flushing
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Hypotension
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Skin atrophy
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected32 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Director, Clinical Science
Takeda
+1-877-825-3327
trialdisclosures@takeda.com
ID
Term
D011471
Prostatic Neoplasms
Ancestor Terms
ID
Term
D005834
Genital Neoplasms, Male
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D005832
Genital Diseases, Male
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D011469
Prostatic Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C571806
orteronel
D011241
Prednisone
Ancestor Terms
ID
Term
D011244
Pregnadienediols
D011245
Pregnadienes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
71.5
(51 to 85)
BG00469.6(51 to 85)
BG00569.9(55 to 84)
BG00673.3(60 to 84)
BG00769.4(49 to 88)
BG00870.6(49 to 88)
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Male
BG00011
BG00122
BG00210
BG00322
BG00411
BG00525
BG00612
BG00724
BG008137
0
BG0030
BG0040
BG0050
BG0060
BG0071
BG0081
Not Hispanic or Latino
BG00011
BG00122
BG00210
BG00322
BG00411
BG00525
BG00612
BG00723
BG008136
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
0
BG0030
BG00411
BG00525
BG00611
BG00723
BG00870
Black or African American
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0071
BG0082
Asian - Japanese
Title
Measurements
BG00011
BG00122
BG00210
BG00322
BG0040
BG0050
BG0060
BG0070
BG00865
10
BG00322
BG0040
BG0050
BG0060
BG0070
BG00865
Australia
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0043
BG0051
BG0062
BG0072
BG0088
Greece
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0042
BG0054
BG0061
BG0073
BG00810
Ireland
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0042
BG0055
BG0063
BG0073
BG00813
Netherlands
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0056
BG0061
BG0075
BG00813
United Kingdom
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0061
BG0071
BG0083
United States
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0042
BG0059
BG0064
BG00710
BG00825
163.92
(156.6 to 170.7)
BG003164.71(151.0 to 174.0)
BG004170.41(157.0 to 184.7)
BG005174.79(162.0 to 186.0)
BG006176.70(165.0 to 185.4)
BG007174.74(162.0 to 189.0)
BG008169.29(151.0 to 189.0)
65.75
(55.5 to 76.0)
BG00364.49(44.7 to 87.1)
BG00487.34(67.0 to 113.0)
BG00590.39(64.0 to 130.7)
BG00688.23(64.9 to 114.1)
BG00789.85(63.0 to 134.6)
BG00877.77(44.7 to 134.6)
24.43
(21.1 to 28.7)
BG00323.73(16.7 to 32.0)
BG00429.85(23.8 to 37.8)
BG00529.61(22.1 to 40.3)
BG00628.37(18.9 to 39.9)
BG00729.40(22.9 to 40.2)
BG00826.96(16.7 to 40.3)
OG00023
OG00124
Title
Denominators
Categories
Title
Measurements
OG00048.0(26.8 to 69.4)
OG00179.0(57.8 to 92.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
0.0355
Odds Ratio (OR)
4.145
2-Sided
95
0.9895
18.7606
Odds ratio >1 favors orteronel.
Superiority or Other
OG003
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG004
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG005
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00021
OG00122
OG00222
OG00320
OG00421
OG00522
Title
Denominators
Categories
Title
Measurements
OG000-87.666± 10.4250
OG001-97.245± 1.2548
OG002-96.812± 2.7055
OG003-63.702± 43.3941
OG004-86.268± 37.2015
OG005-53.954± 118.8050
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00031
OG00126
OG00228
OG00331
Title
Denominators
Categories
Title
Measurements
OG000-95.804± 5.3367
OG001-95.703± 5.7468
OG002-91.311± 17.5217
OG003-14.442± 406.3116
OG003
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG004
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG005
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00021
OG00122
OG00222
OG00323
OG00425
OG00524
Title
Denominators
Categories
Title
Measurements
OG00048.0(25.7 to 70.2)
OG00150.0(28.2 to 71.8)
OG00241.0(20.7 to 63.6)
OG00317.0(5.0 to 38.8)
OG00448.0(27.8 to 68.7)
OG00546.0(25.6 to 67.2)
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00033
OG00132
OG00236
OG00336
Title
Denominators
Categories
Title
Measurements
OG00055.0(36.4 to 71.9)
OG00147.0(29.1 to 65.3)
OG00256.0(38.1 to 72.1)
OG00344.0(27.9 to 61.9)
OG003
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG004
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG005
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00021
OG00122
OG00222
OG00323
OG00425
OG00524
Title
Denominators
Categories
Baseline
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00425
ParticipantsOG00524
Title
Measurements
OG0009.749± 3.8460
OG0019.079± 4.4581
OG00210.148± 4.6504
OG003
Cycle 1 Day 8
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00319
Cycle 2 Day 1
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00320
OG003
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG004
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG005
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00021
OG00122
OG00222
OG00323
OG00425
OG00524
Title
Denominators
Categories
Baseline
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00425
ParticipantsOG00524
Title
Measurements
OG0001928.0± 1306.59
OG0012529.0± 1309.39
OG0022340.9± 1606.36
OG003
Cycle 1 Day 8
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00320
Cycle 2 Day 1
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00320
OG003
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG004
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG005
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00021
OG00122
OG00222
OG00323
OG00425
OG00524
Title
Denominators
Categories
Baseline
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00425
ParticipantsOG00524
Title
Measurements
OG0005.0± 1.66
OG0015.5± 2.54
OG0028.3± 4.98
OG003
Cycle 1 Day 8
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00322
Cycle 2 Day 1
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00322
OG003
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG004
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG005
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00021
OG00122
OG00222
OG00323
OG00425
OG00524
Title
Denominators
Categories
Baseline
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00425
ParticipantsOG00524
Title
Measurements
OG0005.946± 3.4433
OG0016.515± 4.8246
OG0027.768± 6.8625
OG003
Cycle 1 Day 8
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00320
Cycle 2 Day 1
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00320
OG003
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG004
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG005
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00021
OG00122
OG00222
OG00323
OG00425
OG00524
Title
Denominators
Categories
Baseline
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00425
ParticipantsOG00524
Title
Measurements
OG000366.5± 116.69
OG001371.3± 119.38
OG002383.4± 125.98
OG003
Cycle 1 Day 8
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Cycle 2 Day 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00321
OG003
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG004
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG005
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00021
OG00122
OG00222
OG00323
OG00425
OG00524
Title
Denominators
Categories
Baseline
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00425
ParticipantsOG00524
Title
Measurements
OG00037.588± 48.9413
OG00127.227± 24.8821
OG00297.504± 293.9496
OG003
Cycle 2 Day 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00321
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00022
OG00122
OG00225
OG00324
Title
Denominators
Categories
Orteronel
Title
Measurements
OG0001520± 23.9
OG0012210± 33.9
OG0021300± 59.7
OG0031610± 50.3
Orteronel Metabolite M-I
Title
Measurements
OG000272± 33.1
OG001422± 37.0
OG002199± 61.9
OG003
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00022
OG00122
OG00225
OG00324
Title
Denominators
Categories
Orteronel
Title
Measurements
OG0008810± 16.4
OG00112800± 31.2
OG0027830± 51.1
OG00310200± 41.4
Orteronel Metabolite M-I
Title
Measurements
OG0002130± 28.3
OG0013290± 33.8
OG0021570± 65.5
OG003
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00022
OG00122
OG00225
OG00324
Title
Denominators
Categories
Orteronel
Title
Measurements
OG0002.97(1.00 to 5.10)
OG0012.43(1.00 to 4.97)
OG0022.00(0.500 to 7.93)
OG0031.92(0.500 to 5.00)
Orteronel Metabolite M-I
Title
Measurements
OG0005.00(2.03 to 8.10)
OG0014.98(2.00 to 8.23)
OG0025.05(1.03 to 11.1)
OG003
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00022
OG00122
OG00225
OG00324
Title
Denominators
Categories
Orteronel
Title
Measurements
OG000115.0± 26.0
OG001164.0± 26.2
OG00295.3± 31.9
OG003161.0± 41.4
Orteronel Metabolite M-I
Title
Measurements
OG00039.6± 31.5
OG00162.5± 26.6
OG00230.0± 40.1
OG003
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00022
OG00122
OG00225
OG00324
Title
Denominators
Categories
Orteronel
Title
Measurements
OG0002180± 22.4
OG0013210± 31.5
OG0021840± 37.1
OG0033100± 45.0
Orteronel Metabolite M-I
Title
Measurements
OG000565± 32.4
OG001864± 39.5
OG002485± 75.4
OG003
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00022
OG00122
OG00225
OG00324
Title
Denominators
Categories
Orteronel
Title
Measurements
OG0002.05(1.00 to 5.08)
OG0012.96(1.00 to 5.17)
OG0022.00(0.550 to 5.17)
OG0031.98(0.500 to 3.08)
Orteronel Metabolite M-I
Title
Measurements
OG0003.08(2.00 to 5.17)
OG0014.78(2.00 to 8.13)
OG0023.00(1.00 to 5.07)
OG003
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00022
OG00122
OG00225
OG00324
Title
Denominators
Categories
Orteronel
Title
Measurements
OG00013300± 20.4
OG00120400± 36.1
OG00212600± 36.2
OG00320000± 55.0
Orteronel Metabolite M-I
Title
Measurements
OG0004840± 35.0
OG0017460± 46.3
OG0024340± 69.4
OG003
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00022
OG00122
OG00225
OG00324
Title
Denominators
Categories
Orteronel
Title
Measurements
OG0001.51± 9.1
OG0011.59± 46.6
OG0021.62± 39.3
OG0031.97± 90.5
Orteronel Metabolite M-I
Title
Measurements
OG0002.27± 17.5
OG0012.26± 43.0
OG0022.76± 45.0
OG003
OG003
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Units
Counts
Participants
OG00022
OG00122
OG00224
OG00322
Title
Denominators
Categories
Orteronel
Title
Measurements
OG000710± 28.1
OG0011060± 63.7
OG002807± 45.4
OG003899± 59.8
Orteronel Metbolite M-I
Title
Measurements
OG000291± 47.1
OG001444± 66.7
OG002314± 68.6
OG003
OG001
Orteronel 200 mg (Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan and ex-Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG002
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG003
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG004
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
OG005
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.