Study Comparing Orteronel Plus Prednisone in Participants... | NCT01193244

ID	Type	Description
2010-018661-35	EudraCT Number
0991413276	Other Identifier	TCTIP
10/H0406/75	Registry Identifier	NRES
U1111-1181-0387	Registry Identifier	WHO

Label	Type	Description	Intervention Names
Orteronel + prednisone	Experimental		Drug: Orteronel Drug: Prednisone
Placebo + prednisone	Placebo Comparator		Drug: Placebo Drug: Prednisone

Name	Type	Description	Arm Group Labels	Other Names
Orteronel	Drug	Orteronel will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of <50 ng/dL.

Measure	Description	Time Frame
Radiographic Progression-free Survival (rPFS)	rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment.	Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)
Overall Survival	Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.	Baseline until death (up to 4.7 years)

Measure	Description	Time Frame
Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12	The PSA50 is defined as a decline of at least 50 percent (%) from baseline.	Week 12
Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12

Name	Affiliation	Role
Medical Monitor	Millennium Pharmaceuticals, Inc.	Study Director

PubMed Identifier	Type	Citation	Retractions
29272162	Derived	Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.
26031410

ID	Title	Description
FG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
FG001	Orteronel 400 mg + Prednisone 5 mg

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

Radiographic Progression-free Survival (rPFS)

rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment.

ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants	OG000779 OG001781

Title

Denominators

Categories

Title	Measurements
	OG0008.7(8.32 to 10.91) OG00113.8(13.05 to 14.92)

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	Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at Baseline.	Log Rank		<0.00001		Hazard Ratio (HR)	0.707				95	0.626	0.799					Superiority or Other

Primary

Overall Survival

Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.

ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Baseline until death (up to 4.7 years)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12

The PSA50 is defined as a decline of at least 50 percent (%) from baseline.

ITT population included all participants who were randomized.

Posted

Number

95% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants

Secondary

Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12

A favorable CTC count was defined as less than <5 counts per 7.5 milliliter (mL) in whole blood. An unfavorable CTC count was defined as greater than or equal to (>=) 5 counts/7.5 mL in whole blood.

ITT population included all participants who were randomized.

Posted

Number

95% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants

Secondary

Time to Pain Progression

Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >=4 with a >=2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >=4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <=3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 100 with lower scores being indicative of less pain or pain interference.

ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Baseline until End of treatment (EOT) (approximately up to 4.7 years)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Secondary

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Safety population included all participants who received at least 1 dose of any study drug.

Posted

Number

participants

Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3

Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE.

Safety population included all participants who received at least 1 dose of any study drug.

Posted

Number

participants

Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units

Secondary

Number of Participants With TEAEs Related to Vital Signs

Safety population included all participants who received at least 1 dose of any study drug.

Posted

Number

participants

Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants	OG000

Secondary

Number of Participants With TEAEs Related to Weight

Safety population included all participants who received at least 1 dose of any study drug.

Posted

Number

participants

Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status

ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50 percent of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50 percent of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period.

Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.

Posted

Number

participants

Baseline until EOT (approximately up to 4.7 years)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Secondary

Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings

Safety population included all participants who received at least 1 dose of any study drug.

Posted

Number

participants

Baseline up to EOT (Cycle 61 Day 58)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants	OG000

Secondary

Worst Change From Baseline Over Time in Cardiac Ejection Fraction

Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point.

Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.

Posted

Mean

Standard Deviation

percent ejection fraction

Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts

Secondary

Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation

Safety population included all participants who received at least 1 dose of any study drug.

Posted

Number

participants

Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Skeletal Related Events (SRE)

Skeletal related (SRE) event is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence.

The ITT population included all participants who were randomized.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline up to EOT (approximately up to 4.7 years)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants

Secondary

Time to SRE

Time to SRE is defined as the time from randomization to SRE, or death due to any cause, whichever comes first. SRE is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence.

The ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Baseline up to EOT (Cycle 61 Day 58)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving PSA50 Response at Any Time During the Study

The PSA50 is defined as a decline of PSA by 50 percent from baseline.

ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.

Posted

Number

95% Confidence Interval

percentage of participants

Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12

The PSA90 is defined as a decline of PSA by 90 percent from baseline.

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving PSA90 Response at Any Time During the Study

The PSA90 is defined as a decline of PSA by 90 percent from baseline.

ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.

Posted

Number

95% Confidence Interval

percentage of participants

Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts
Participants

Secondary

Time to PSA Progression

Time to PSA progression was defined as time from randomization to a PSA increase of 25 percent and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, compared to baseline PSA.

ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.7 years)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units

Secondary

Time to Docetaxel Chemotherapy

Time to docetaxel based chemotherapy is defined as the time from randomization to the start of docetaxel based chemotherapy for prostate cancer, regardless of whether the participant received concurrent orteronel or not. Deaths due to disease progression prior to Docetaxel based chemotherapy were considered as events.

ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Baseline until start of docetaxel chemotherapy (up to 4.7 years)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Units	Counts

Secondary

Time to Subsequent Antineoplastic Therapy

Time to subsequent antineoplastic therapy is defined as the time from randomization to the start of any alternate antineoplastic therapy for prostate cancer. Deaths due to disease progression prior to antineoplastic therapy for prostate cancer are considered as events. Otherwise, time to next therapy is censored at the date of death or the last date the participant was known to be alive or the data cutoff date, whichever is earlier.

The ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Baseline until start of subsequent antineoplastic therapy (up to 4.7 years)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Secondary

Percentage of Participants With Objective Response

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. A CR was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter or short axis of lymph nodes.

The Response Evaluation Criteria in Solid Tumors (RECIST) evaluable population included all participants who had measurable disease by RECIST 1.1 at the baseline assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Secondary

Time to Deterioration in Global Health Status

Global health status deterioration is defined as a drop greater than 16 points from the baseline assessment, confirmed at least 3 weeks later, on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module 30 (EORTC QLQ-C30) index after the score has been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30 consists of 30 questions, where question 1 to 28 can be answered with 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much and question 29 to 30 with 1: Very poor to 7: Excellent. For subscales a high score from 0-100 indicates: high global quality of life, high level of functioning (physical, role, emotional, cognitive, social) or a high level of symptoms (fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties).

The ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Baseline until EOT (approximately up to 4.7 years)

ID	Title	Description
OG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
OG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0009 affected770 at risk EG00130 affected784 at risk
Lobar pneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0012 affected784 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Bronchopneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Lung infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Bronchitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Sepsis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG00112 affected784 at risk
Urosepsis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0004 affected770 at risk EG0016 affected784 at risk
Septic shock	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0013 affected784 at risk
Bacteraemia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Post procedural sepsis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Pulmonary sepsis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0009 affected770 at risk EG00113 affected784 at risk
Pyelonephritis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0010 affected784 at risk
Gastroenteritis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0004 affected770 at risk EG0013 affected784 at risk
Appendicitis perforated	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Diverticulitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Cellulitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0014 affected784 at risk
Arthritis bacterial	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Cellulitis gangrenous	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Gangrene	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Abscess limb	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Groin abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Pelvic abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Postoperative abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Erysipelas	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0014 affected784 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Herpes zoster	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0014 affected784 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0012 affected784 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Osteomyelitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0013 affected784 at risk
Intervertebral discitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Bursitis infective	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Abscess neck	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Muscle abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Perineal abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Diabetic foot infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Skin infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Pilonidal cyst	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Chronic sinusitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Labyrinthitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Fungal oesophagitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Influenza	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Salmonellosis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Borrelia infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Tongue abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Staphylococcal infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Tuberculosis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0006 affected770 at risk EG0019 affected784 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0019 affected784 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected770 at risk EG00112 affected784 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0018 affected784 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0015 affected784 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0014 affected784 at risk
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected770 at risk EG0017 affected784 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Ileus	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0013 affected784 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0011 affected784 at risk
Gallstone ileus	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0011 affected784 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Duodenitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected770 at risk EG0011 affected784 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Anal stenosis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Toothache	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Proctitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG00025 affected770 at risk EG00124 affected784 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0014 affected784 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0007 affected770 at risk EG00112 affected784 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0004 affected770 at risk EG0012 affected784 at risk
Oncologic complication	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Metastases to biliary tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Metastases to bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Metastases to small intestine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Metastases to rectum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Metastases to urinary tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0010 affected784 at risk
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0012 affected784 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Fibromatosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0017 affected784 at risk
Myocardial infarction	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected770 at risk EG0015 affected784 at risk
Angina pectoris	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected770 at risk EG0014 affected784 at risk
Angina unstable	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0012 affected784 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG00018 affected770 at risk EG00114 affected784 at risk
Atrial flutter	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0013 affected784 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0013 affected784 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Cardiac failure	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0007 affected770 at risk EG0018 affected784 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0012 affected784 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0011 affected784 at risk
Arrhythmia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Bradycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Extrasystoles	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Tachycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Cardiac arrest	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0012 affected784 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Coronary artery disease	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0012 affected784 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Cardiomegaly	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Ventricular hypertrophy	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Cardiotoxicity	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Pericardial effusion	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Atrioventricular block	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Conduction disorder	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG00023 affected770 at risk EG00127 affected784 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected770 at risk EG0017 affected784 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0012 affected784 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0013 affected784 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Pharyngeal pouch	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0006 affected770 at risk EG0019 affected784 at risk
Renal failure	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0017 affected784 at risk
Renal impairment	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0013 affected784 at risk
Postrenal failure	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0012 affected784 at risk
Renal injury	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Urinary retention	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG00020 affected770 at risk EG00113 affected784 at risk
Urinary hesitation	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Haematuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG00016 affected770 at risk EG0018 affected784 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0006 affected770 at risk EG0015 affected784 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0010 affected784 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0013 affected784 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Hydroureter	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Urinary bladder rupture	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Renal colic	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Azotaemia	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Renal artery thrombosis	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0008 affected770 at risk EG0015 affected784 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Cerebellar haemorrhage	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Cerebral infarction	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Syncope	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected770 at risk EG0017 affected784 at risk
Somnolence	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Spinal cord compression	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG00011 affected770 at risk EG0016 affected784 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Radicular pain	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Nerve root compression	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Dizziness	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Presyncope	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Paraplegia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Hemiplegia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Monoplegia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Hemiparesis	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Seizure	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0013 affected784 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0012 affected784 at risk
Polyneuropathy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Nystagmus	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Encephalopathy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0010 affected784 at risk
IIIrd nerve disorder	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Parkinson's disease	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Tremor	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Fatigue	General disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG00111 affected784 at risk
Asthenia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0013 affected784 at risk
Malaise	General disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0012 affected784 at risk
General physical health deterioration	General disorders	MedDRA (18.0)	Systematic Assessment	EG0006 affected770 at risk EG0019 affected784 at risk
Multi-organ failure	General disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0013 affected784 at risk
Multi-organ disorder	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Performance status decreased	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Pyrexia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0016 affected784 at risk
Non-cardiac chest pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0014 affected784 at risk
Discomfort	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Chest pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0010 affected784 at risk
Oedema peripheral	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Face oedema	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Death	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Device occlusion	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Abasia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Drug intolerance	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0008 affected770 at risk EG00111 affected784 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0018 affected784 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0015 affected784 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0016 affected784 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0014 affected784 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0013 affected784 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected770 at risk EG0012 affected784 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0012 affected784 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0010 affected784 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0010 affected784 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0008 affected770 at risk EG00112 affected784 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0011 affected784 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected770 at risk EG0016 affected784 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0015 affected784 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0008 affected770 at risk EG0013 affected784 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0013 affected784 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected770 at risk EG0011 affected784 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Joint destruction	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected770 at risk EG0019 affected784 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0013 affected784 at risk
Hypotension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Hypertension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0014 affected784 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Shock	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Femoral artery occlusion	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Flushing	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Aortic stenosis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Hypertensive crisis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Haematoma	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Venous thrombosis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Phlebitis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Lymphoedema	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Lipase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0005 affected770 at risk EG0017 affected784 at risk
Amylase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0012 affected784 at risk
Pancreatic enzymes increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Alanine aminotransferase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Hepatic enzyme increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Liver function test abnormal	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Transaminases increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Blood creatinine increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0016 affected784 at risk
Ejection fraction decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
International normalised ratio increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0012 affected784 at risk
Blood calcium increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Eastern Cooperative Oncology Group performance status worsened	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Neutrophil count decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0003 affected770 at risk EG0010 affected784 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0006 affected770 at risk EG0013 affected784 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0013 affected784 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0010 affected784 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Fractured ischium	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Post procedural pulmonary embolism	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Urethral stricture postoperative	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG00018 affected770 at risk EG00118 affected784 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected770 at risk EG0010 affected784 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0014 affected784 at risk
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0012 affected784 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Thyrotoxic crisis	Endocrine disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0013 affected784 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0010 affected784 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0011 affected784 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Delirium	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Confusional state	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Depression	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Mental status changes	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Mood disorder due to a general medical condition	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0011 affected784 at risk
Allergy to arthropod sting	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk
Drug hypersensitivity	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Cataract	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected770 at risk EG0010 affected784 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected770 at risk EG0010 affected784 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected770 at risk EG0011 affected784 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Anchorage	Alaska		United States

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

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Placebo + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
BG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
BG002	Total	Total of all reporting 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 + Prednisone 5 mg	Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.			321	770	721	770
EG001	Orteronel 400 mg + Prednisone 5 mg	Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.			380	784	757	784