Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00323882

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

5.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Neoplasm Metastasis	Drug: MDX-010	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I/II, Open-label, Dose-escalation Study of MDX-010 Administered Every 3 Weeks for 4 Doses in Patients With Metastatic Hormone-Refractory Prostate Cancer

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MDX-010	Drug: MDX-010 selected dose administered IV every 3 weeks

Arm

Intervention/Treatment

Experimental: MDX-010

Drug: MDX-010

selected dose administered IV every 3 weeks

Outcome Measures

Primary Outcome Measures

Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants [Day 1 to last day of study treatment (+70 days) up to 2 years]
AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AE (irAE) was defined as a clinically significant AE of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism. Day 1=first day of study treatment.
Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants [Day 85]
Response by investigator using National Cancer Institute (NCI) PSA Working Group recommendations= PSA < 50% of PSA reference value occurring on or before Day 85; response confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. Complete response (CR)=PSA < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; Partial response (PR)=PSA ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; Stable disease(SD)=No change from PSA reference; Progressive disease (PD) defined: If PSA nadir was ≥ 100% of the reference: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.

Secondary Outcome Measures

Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants [Day 1 to last day of study treatment (+70 days) up to 2 years]
Best Overall PSA response per investigator, using NCI PSA Working Group: PSA with CR or PR at any time after treatment initiation and was confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. CR=PSA concentration < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; SD=No change from PSA reference value; PD = If PSA nadir was ≥ 100% of the reference value: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference value: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference value: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.
Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants [Day 1 to last day of study treatment (+70 days) up to 2 years]
For those with measurable disease, tumor response based upon tumor lesions (per investigator) using Response Evaluation Criteria in Solid Tumors (RECIST). Best Overall=Participants with a best tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met; Unconfirmed=not confirmed by repeat measurements; SD=Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85 [Day 1 to Day 85]
Time to PSA response was measured in months. Time to PSA response was analyzed in those participants with CR or PR at Day 85. CR=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value.
Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy [Day 1 to last day of study treatment (+70 days) up to 2 years]
Tumor response rate was defined as the number of participants with a best response of partial or complete response divided by the total number of tumor evaluable participants. Overall Tumor Response was defined as participants with a tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met
PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy [Day 85, Day 1 to last day of study treatment (+70 days) up to 2 years]
PSA response rate was defined as the number of participants with a PSA response (PR or CR) divided by the total number of PSA evaluable participants. PSA response at Day 85, as reported by the investigator, was defined as a PSA concentration < 50% of the PSA reference value occurring on or before Day 85 and this response was confirmed at least 4 weeks after the first determination. The PSA reference value was the PSA concentration measured immediately prior to treatment. Overall Response is < 50% of the PSA reference value occurring anytime after treatment was initiated and this response was confirmed at least 4 weeks after the first determination. Complete response=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after first value; Partial response=PSA concentration ≤ 50% of PSA reference value, confirmed at least 4 weeks after first determination.
Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants [Day 1 to 5 years post treatment]
Primary analysis was conducted on data from Day 1 up to 2 years post treatment, data available as of September 2009. Final Follow-Up analysis was conducted on data up to 5 years post treatment, data available as of September 2013 (minimum time of eligibility 54 months to a maximum of 85 months). Primary causes of deaths are listed under each timepoint.
Overall Survival at Completion of Follow Up Period - Treated Participants [Day 1 to 5 years post treatment]
Overall Survival (OS) was defined as the time from the first date of study treatment until the date of death and was measured in months. For those participants who have not died, OS was censored at the last date the participant was known to be alive. Completion of follow-up for OS was a minimum time of eligibility 54 months to a maximum of 85 months.
Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants [Day 1 to last day of study treatment (+70 days) up to 2 years]
NCI CTC version(v) 3.0 was used to determine Grade (Gr). Screening was Day -28 to Day -1. On-study laboratories were reported after the first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Hemoglobin grams per liter (g/L): Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. White blood cells(WBC) 10^9 cells per liter (c/L): Gr1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Lymphocytes (absolute) 10^9 c/L: Gr1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Neutrophils (absolute) 10^9 c/L: Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Platelets 10^9 c/L: Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.
Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants [Day 1 to last day of study treatment (+70 days) up to 2 years]
CTC v3.0 used. On-study serum chemistry laboratories were reported after first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Alanine Aminotransferase (ALT) Units per Liter (U/L) Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST) U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Total Bilirubin micromoles per liter (µmol/L): Gr 1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Amylase U/L: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN. Creatinine µmol/L: Gr1: > 1.0 - 1.5*ULN; Gr2: > 1.5 - 3.0*ULN; Gr3: > 3.0 - 6.0*ULN; Gr4: > 6.0*ULN.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants [Baseline up to 2 years]
12 Lead Electrocardiograms (ECGs) were performed at screening (Day -28 to Day -1), and on Day 85 during a treatment cycle, and at the end of treatment period. Clinically significant abnormalities could include atrial fibrillation, anterior fascicular block, marked sinus bradycardia, possible lateral infarct, and T-wave abnormality (other potential abnormalities were not excluded from consideration).
Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants [Day 1 up to 2 years]
HAHA was measured by electrochemiluminescent (ECL) immunoassay for the detection of antibodies in human heparin plasma. Testing was performed on Days 1 (prior to ipilimumab infusion), 64, 85, and at completion of treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologic diagnosis of adenocarcinoma of the prostate
Metastatic prostate cancer (positive bone scan or measurable disease)
Total testosterone of less than 50 ng/dL, except for patients with prior orchiectomy, where testosterone does not need to be measured.
Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen and completion of a washout period and then observe disease progression.
Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products.
Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required.
Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.
No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.

Exclusion Criteria:

Bone pain due to metastatic bone disease severe enough to require routine narcotic analgesic use.
History of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo.
Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.
Active infection requiring therapy.
Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Angeles Clinic and Research Institute	Los Angeles	California	United States	11818
2	The Angeles Clinic and Research Institute	Los Angeles	California	United States	90025
3	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	United States	94115
4	Yale University School of Medicine	New Haven	Connecticut	United States	06520
5	Josephine Ford Cancer Center-Downriver	Brownstown	Michigan	United States	48183
6	Henry Ford Medical Center-Fairlane	Dearborn	Michigan	United States	48126
7	Henry Ford Hospital	Detroit	Michigan	United States	48202-2689
8	Henry Ford Medical Center-West Bloomfield	West Bloomfield	Michigan	United States	48322
9	Washington University School of Medicine	St. Louis	Missouri	United States	63110
10	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
11	Carolina BioOncology Institute	Huntersville	North Carolina	United States	28078
12	Oregon Health and Science University	Portland	Oregon	United States	97239-3098
13	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
14	University of Washington Medical Center	Seattle	Washington	United States	98195

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00323882

Other Study ID Numbers:

CA184-017 ST
CA184-017

First Posted:

May 10, 2006

Last Update Posted:

Aug 28, 2014

Last Verified:

Aug 1, 2014

Keywords provided by Bristol-Myers Squibb

Metastatic Hormone-Refractory Prostate Cancer (HRPC)

Additional relevant MeSH terms:

Prostatic Neoplasms

Neoplasm Metastasis

Ipilimumab

Study Results

Participant Flow

Recruitment Details	Study initiated January 2006; Primary endpoint last visit September 2009; follow up period last visit July 2013 with data cut off September 2013. Male patients with castrate-resistant prostate cancer (CRPC) who met study criteria were enrolled.
Pre-assignment Detail	75 participants enrolled and were assigned to treatment; 71 were treated. Reasons for the 4 participants not receiving treatment were not specified by the investigators. Ipilimumab was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of the induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses (maintenance). The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to Response Evaluation Criteria in Solid Tumors (RECIST), target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Period Title: Overall Study
STARTED	8	6	16	7	34
COMPLETED	0	0	3	0	2
NOT COMPLETED	8	6	13	7	32

Baseline Characteristics

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination	Total
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	Total of all reporting groups
Overall Participants	8	6	16	7	34	71
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.0 (8.1)	58.2 (5.6)	65.2 (7.7)	67.6 (8.5)	65.7 (9.1)	65.4 (8.5)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	8 100%	6 100%	16 100%	7 100%	34 100%	71 100%
Race/Ethnicity, Customized (participants) [Number]
Asian	0 0%	0 0%	0 0%	0 0%	1 2.9%	1 1.4%
Black	0 0%	0 0%	0 0%	1 14.3%	3 8.8%	4 5.6%
White	8 100%	6 100%	16 100%	6 85.7%	30 88.2%	66 93%
Region of Enrollment (participants) [Number]
United States	8 100%	6 100%	16 100%	7 100%	34 100%	71 100%
Mean Prostate-Specific Antigen (PSA) in ng/mL (ng/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/mL]	121.6 (140.2)	48.8 (43.9)	302.7 (521.2)	66.6 (68.1)	250.1 (324.1)	212.9 (346.5)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (participants) [Number]
ECOG PS 0	5 62.5%	5 83.3%	10 62.5%	4 57.1%	9 26.5%	33 46.5%
ECOG PS 1	3 37.5%	1 16.7%	6 37.5%	2 28.6%	22 64.7%	34 47.9%
ECOG PS 2	0 0%	0 0%	0 0%	1 14.3%	0 0%	1 1.4%
ECOG PS Not Reported	0 0%	0 0%	0 0%	0 0%	3 8.8%	3 4.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants
Description	AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AE (irAE) was defined as a clinically significant AE of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism. Day 1=first day of study treatment.
Time Frame	Day 1 to last day of study treatment (+70 days) up to 2 years

Outcome Measure Data

Analysis Population Description
All participants in the study who received either ipilimumab or radiation were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	8	6	16	7	34
SAE	3 37.5%	2 33.3%	9 56.3%	2 28.6%	19 55.9%
Drug-Related SAE	2 25%	1 16.7%	7 43.8%	2 28.6%	7 20.6%
AEs leading to discontinuation	2 25%	2 33.3%	7 43.8%	3 42.9%	13 38.2%
Related-AEs leading to discontinuation	2 25%	2 33.3%	6 37.5%	3 42.9%	8 23.5%
Grade 3-4 AE	2 25%	5 83.3%	12 75%	3 42.9%	20 58.8%
Related AE (Any Grade)	8 100%	5 83.3%	16 100%	6 85.7%	29 85.3%
Grade 3-4 Related AE	2 25%	3 50%	10 62.5%	3 42.9%	13 38.2%
irAE (Any Grade)	6 75%	5 83.3%	16 100%	4 57.1%	24 70.6%
Grade 3-4 irAE	1 12.5%	3 50%	10 62.5%	3 42.9%	6 17.6%

2. Secondary Outcome

Title	Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants
Description	Best Overall PSA response per investigator, using NCI PSA Working Group: PSA with CR or PR at any time after treatment initiation and was confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. CR=PSA concentration < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; SD=No change from PSA reference value; PD = If PSA nadir was ≥ 100% of the reference value: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference value: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference value: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.
Time Frame	Day 1 to last day of study treatment (+70 days) up to 2 years

Outcome Measure Data

Analysis Population Description
PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	8	6	16	6	34
Complete Response (CR)	0 0%	0 0%	1 6.3%	0 0%	2 5.9%
Partial Response (PR)	2 25%	1 16.7%	3 18.8%	2 28.6%	2 5.9%
Unconfirmed Partial Response	0 0%	0 0%	2 12.5%	0 0%	2 5.9%
Stable Disease (SD)	3 37.5%	4 66.7%	6 37.5%	2 28.6%	14 41.2%
Progressive Disease (PD)	3 37.5%	1 16.7%	3 18.8%	2 28.6%	11 32.4%
Unknown	0 0%	0 0%	1 6.3%	0 0%	3 8.8%

3. Secondary Outcome

Title	Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants
Description	For those with measurable disease, tumor response based upon tumor lesions (per investigator) using Response Evaluation Criteria in Solid Tumors (RECIST). Best Overall=Participants with a best tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met; Unconfirmed=not confirmed by repeat measurements; SD=Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame	Day 1 to last day of study treatment (+70 days) up to 2 years

Outcome Measure Data

Analysis Population Description
Tumor-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had measurable disease at baseline, were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	1	1	8	2	20
Complete Response	0 0%	0 0%	1 6.3%	0 0%	0 0%
Partial Response	0 0%	0 0%	0 0%	0 0%	0 0%
Unconfirmed Partial Response	0 0%	0 0%	1 6.3%	0 0%	1 2.9%
Stable Disease	1 12.5%	1 16.7%	1 6.3%	1 14.3%	5 14.7%
Progressive Disease	0 0%	0 0%	3 18.8%	1 14.3%	5 14.7%
Unknown	0 0%	0 0%	2 12.5%	0 0%	9 26.5%

4. Secondary Outcome

Title	Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85
Description	Time to PSA response was measured in months. Time to PSA response was analyzed in those participants with CR or PR at Day 85. CR=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value.
Time Frame	Day 1 to Day 85

Outcome Measure Data

Analysis Population Description
All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab, had a baseline PSA, and had a confirmed Complete Response (CR) or Partial Response (PR) at Day 85.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)	Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	1	1	3	0	2	2
Median (Full Range) [Months]	1.41	1.54	1.4	1.1	1.1

5. Secondary Outcome

Title	Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy
Description	Tumor response rate was defined as the number of participants with a best response of partial or complete response divided by the total number of tumor evaluable participants. Overall Tumor Response was defined as participants with a tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met
Time Frame	Day 1 to last day of study treatment (+70 days) up to 2 years

Outcome Measure Data

Analysis Population Description
All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)	Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)
Arm/Group Description	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	In those participants who had received no chemotherapy prior to the study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	8	16	4
Number (95% Confidence Interval) [percentage of participants]	12.5 156.3%	0 0%	0 0%

6. Secondary Outcome

Title	PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy
Description	PSA response rate was defined as the number of participants with a PSA response (PR or CR) divided by the total number of PSA evaluable participants. PSA response at Day 85, as reported by the investigator, was defined as a PSA concentration < 50% of the PSA reference value occurring on or before Day 85 and this response was confirmed at least 4 weeks after the first determination. The PSA reference value was the PSA concentration measured immediately prior to treatment. Overall Response is < 50% of the PSA reference value occurring anytime after treatment was initiated and this response was confirmed at least 4 weeks after the first determination. Complete response=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after first value; Partial response=PSA concentration ≤ 50% of PSA reference value, confirmed at least 4 weeks after first determination.
Time Frame	Day 85, Day 1 to last day of study treatment (+70 days) up to 2 years

Outcome Measure Data

Analysis Population Description
All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)	Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)
Arm/Group Description	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	In those participants with no prior chemotherapy, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	16	21	13
PSA Response Rate at Day 85	18.8 235%	9.5 158.3%	15.4 96.3%
Overall PSA Response Rate	25.0 312.5%	9.5 158.3%	15.4 96.3%

7. Primary Outcome

Title	Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants
Description	Response by investigator using National Cancer Institute (NCI) PSA Working Group recommendations= PSA < 50% of PSA reference value occurring on or before Day 85; response confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. Complete response (CR)=PSA < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; Partial response (PR)=PSA ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; Stable disease(SD)=No change from PSA reference; Progressive disease (PD) defined: If PSA nadir was ≥ 100% of the reference: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.
Time Frame	Day 85

Outcome Measure Data

Analysis Population Description
PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	8	6	16	6	34
Complete Response	0 0%	0 0%	1 6.3%	0 0%	1 2.9%
Partial Response	1 12.5%	1 16.7%	2 12.5%	0 0%	3 8.8%
Unconfirmed Partial Response	0 0%	0 0%	2 12.5%	0 0%	1 2.9%
Stable Disease	4 50%	4 66.7%	7 43.8%	4 57.1%	14 41.2%
Progressive Disease	3 37.5%	1 16.7%	3 18.8%	2 28.6%	11 32.4%
Unknown	0 0%	0 0%	1 6.3%	0 0%	4 11.8%

8. Secondary Outcome

Title	Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants
Description	Primary analysis was conducted on data from Day 1 up to 2 years post treatment, data available as of September 2009. Final Follow-Up analysis was conducted on data up to 5 years post treatment, data available as of September 2013 (minimum time of eligibility 54 months to a maximum of 85 months). Primary causes of deaths are listed under each timepoint.
Time Frame	Day 1 to 5 years post treatment

Outcome Measure Data

Analysis Population Description
Treated participants population included all participants in the study who received either ipilimumab or radiation.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination	All Treated Participants
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	All participants in all treatment arms combined.
Measure Participants	8	6	16	7	34	71
Total Deaths at Primary Analysis	5 62.5%	4 66.7%	7 43.8%	3 42.9%	18 52.9%	37 52.1%
Maliginant Disease	0 0%	0 0%	0 0%	0 0%	3 8.8%	3 4.2%
Prostate Cancer	1 12.5%	3 50%	4 25%	3 42.9%	10 29.4%	21 29.6%
Toxicity	0 0%	1 16.7%	0 0%	0 0%	0 0%	1 1.4%
Other	0 0%	0 0%	0 0%	0 0%	2 5.9%	2 2.8%
Unknown	3 37.5%	0 0%	3 18.8%	0 0%	3 8.8%	9 12.7%
No cause specified	1 12.5%	0 0%	0 0%	0 0%	0 0%	1 1.4%
Total Deaths at Completion of Follow Up	7 87.5%	6 100%	11 68.8%	7 100%	29 85.3%	60 84.5%
Malignant Disease	0 0%	0 0%	0 0%	0 0%	3 8.8%	3 4.2%
Prostate Cancer	1 12.5%	4 66.7%	6 37.5%	4 57.1%	13 38.2%	28 39.4%
Toxicity	0 0%	1 16.7%	0 0%	0 0%	0 0%	1 1.4%
Other	0 0%	1 16.7%	1 6.3%	0 0%	5 14.7%	7 9.9%
Unknown	5 62.5%	0 0%	4 25%	3 42.9%	8 23.5%	20 28.2%
No cause specified	1 12.5%	0 0%	0 0%	0 0%	0 0%	1 1.4%

9. Secondary Outcome

Title	Overall Survival at Completion of Follow Up Period - Treated Participants
Description	Overall Survival (OS) was defined as the time from the first date of study treatment until the date of death and was measured in months. For those participants who have not died, OS was censored at the last date the participant was known to be alive. Completion of follow-up for OS was a minimum time of eligibility 54 months to a maximum of 85 months.
Time Frame	Day 1 to 5 years post treatment

Outcome Measure Data

Analysis Population Description
All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination	All Treated Participants
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	All treatment groups are combined to show total overall survival at completion of Follow Up.
Measure Participants	8	6	16	7	34	71
Median (95% Confidence Interval) [Months]	22.5	36.3	26.6	18.2	9.7	17.4

10. Secondary Outcome

Title	Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants
Description	NCI CTC version(v) 3.0 was used to determine Grade (Gr). Screening was Day -28 to Day -1. On-study laboratories were reported after the first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Hemoglobin grams per liter (g/L): Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. White blood cells(WBC) 10^9 cells per liter (c/L): Gr1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Lymphocytes (absolute) 10^9 c/L: Gr1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Neutrophils (absolute) 10^9 c/L: Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Platelets 10^9 c/L: Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.
Time Frame	Day 1 to last day of study treatment (+70 days) up to 2 years

Outcome Measure Data

Analysis Population Description
All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	8	5	15	6	34
WBC Grade 1-4 (n=8, 5, 15, 6, 34)	0 0%	0 0%	0 0%	1 14.3%	2 5.9%
WBC Grade 3-4 (n=8, 5, 15, 6, 34)	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils Grade 1-4 (n=8, 5, 15, 6, 34)	2 25%	0 0%	0 0%	1 14.3%	2 5.9%
Neutrophils Grade 3-4 (n=8, 5, 15, 6, 34)	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets Grade 1-4 (n=8, 5, 15, 6, 34)	0 0%	0 0%	1 6.3%	1 14.3%	2 5.9%
Platelets Grade 3-4 (n=8, 5, 15, 6, 34)	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin Grade 1-4 (n=8, 5, 15, 6, 34)	7 87.5%	4 66.7%	12 75%	6 85.7%	28 82.4%
Hemoglobin Grade 3-4 (n=8, 5, 15, 6, 34)	0 0%	0 0%	1 6.3%	0 0%	6 17.6%
Lymphocytes Grade 1-4 (n=8, 5, 15, 6, 34)	7 87.5%	3 50%	12 75%	5 71.4%	31 91.2%
Lymphocytes Grade 3-4 (n=8, 5, 15, 6, 34)	0 0%	0 0%	2 12.5%	1 14.3%	3 8.8%

11. Secondary Outcome

Title	Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants
Description	CTC v3.0 used. On-study serum chemistry laboratories were reported after first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Alanine Aminotransferase (ALT) Units per Liter (U/L) Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST) U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Total Bilirubin micromoles per liter (µmol/L): Gr 1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Amylase U/L: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN. Creatinine µmol/L: Gr1: > 1.0 - 1.5ULN; Gr2: > 1.5 - 3.0ULN; Gr3: > 3.0 - 6.0ULN; Gr4: > 6.0ULN.
Time Frame	Day 1 to last day of study treatment (+70 days) up to 2 years

Outcome Measure Data

Analysis Population Description
All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	8	5	15	6	34
ALT Grade 1-4 (n=8,5,15,6,34)	0 0%	2 33.3%	7 43.8%	2 28.6%	10 29.4%
ALT Grade 3-4 (n=8,5,15,6,34)	0 0%	1 16.7%	2 12.5%	0 0%	1 2.9%
AST Grade 1-4 (n=8,5,15,6,34)	0 0%	2 33.3%	6 37.5%	2 28.6%	8 23.5%
AST Grade 3-4 (n=8,5,15,6,34)	0 0%	1 16.7%	2 12.5%	0 0%	0 0%
Bilirubin Grade 1-4 (n=8,5,15,6,34)	0 0%	0 0%	2 12.5%	1 14.3%	1 2.9%
Bilirubin Grade 3-4 (n=8,5,15,6,34)	0 0%	0 0%	0 0%	0 0%	0 0%
Phosphatase Grade 1-4 (n=8,5,15,6,34)	3 37.5%	4 66.7%	7 43.8%	5 71.4%	21 61.8%
Phosphatase Grade 3-4 (n=8,5,15,6,34)	0 0%	0 0%	1 6.3%	1 14.3%	5 14.7%
Amylase Grade 1-4 (n=8,5,15,6,34)	2 25%	3 50%	4 25%	0 0%	4 11.8%
Amylase Grade 3-4 (n=8,5,15,6,34)	0 0%	0 0%	0 0%	0 0%	1 2.9%
Creatinine Grade 1-4 (n=8,5,15,6,34)	0 0%	0 0%	4 25%	1 14.3%	5 14.7%
Creatinine Grade 3-4 (n=8,5,15,6,34)	0 0%	0 0%	0 0%	0 0%	0 0%

12. Secondary Outcome

Title	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants
Description	12 Lead Electrocardiograms (ECGs) were performed at screening (Day -28 to Day -1), and on Day 85 during a treatment cycle, and at the end of treatment period. Clinically significant abnormalities could include atrial fibrillation, anterior fascicular block, marked sinus bradycardia, possible lateral infarct, and T-wave abnormality (other potential abnormalities were not excluded from consideration).
Time Frame	Baseline up to 2 years

Outcome Measure Data

Analysis Population Description
All participants in the study who received either ipilimumab or radiation and had an ECG were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	8	6	15	7	31
ECG Abnormalities at Baseline (n=8, 6, 15, 7, 31)	0 0%	0 0%	2 12.5%	0 0%	0 0%
ECG Abnormalities During Treatment (n=4,3,11,4,20)	0 0%	0 0%	2 12.5%	0 0%	0 0%

13. Secondary Outcome

Title	Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants
Description	HAHA was measured by electrochemiluminescent (ECL) immunoassay for the detection of antibodies in human heparin plasma. Testing was performed on Days 1 (prior to ipilimumab infusion), 64, 85, and at completion of treatment.
Time Frame	Day 1 up to 2 years

Outcome Measure Data

Analysis Population Description
All participants in the study who received either ipilimumab or radiation and had a measurement were analyzed.

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg	Ipilimumab Monotherapy 5 mg/kg	Ipilimumab Monotherapy 10 mg/kg	Ipilimumab 3 mg/kg + XRT Combination Therapy	Ipilimumab 10 mg/kg + XRT Combination
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.	A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
Measure Participants	8	6	16	7	34
Number [participants]	0 0%	0 0%	0 0%	0 0%	0 0%

Adverse Events

	Ipilimumab Monotherapy 3 mg/kg		Ipilimumab Monotherapy 5 mg/kg		Ipilimumab Monotherapy 10 mg/kg		Ipilimumab 3 mg/kg + XRT Combination Therapy		Ipilimumab 10 mg/kg + XRT Combination
Time Frame	Day 1 to last day of study treatment (+70 days) up to 2 years
Adverse Event Reporting Description

Arm/Group Title	Ipilimumab Monotherapy 3 mg/kg		Ipilimumab Monotherapy 5 mg/kg		Ipilimumab Monotherapy 10 mg/kg		Ipilimumab 3 mg/kg + XRT Combination Therapy		Ipilimumab 10 mg/kg + XRT Combination
Arm/Group Description	A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.		A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.		A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.		A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.		A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ipilimumab Monotherapy 3 mg/kg		Ipilimumab Monotherapy 5 mg/kg		Ipilimumab Monotherapy 10 mg/kg		Ipilimumab 3 mg/kg + XRT Combination Therapy		Ipilimumab 10 mg/kg + XRT Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/8 (37.5%)		2/6 (33.3%)		9/16 (56.3%)		2/7 (28.6%)		19/34 (55.9%)
Blood and lymphatic system disorders
Anaemia	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		1/7 (14.3%)		2/34 (5.9%)
Lymphadenopathy	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Thrombocytopenia	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Cardiac disorders
Acute myocardial infarction	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Atrial fibrillation	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Cardio-respiratory arrest	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Atrial flutter	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia haemorrhagic	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Endocrine disorders
Hypophysitis	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Hypopituitarism	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Secondary adrenocortical insufficiency	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Hyperthyroidism	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		0/34 (0%)
Gastrointestinal disorders
Abdominal pain	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Abdominal pain upper	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Vomiting	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		2/34 (5.9%)
Colitis	1/8 (12.5%)		1/6 (16.7%)		4/16 (25%)		1/7 (14.3%)		2/34 (5.9%)
Diarrhoea	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		1/7 (14.3%)		1/34 (2.9%)
Ascites	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Gastrointestinal haemorrhage	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Haematochezia	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Nausea	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		2/34 (5.9%)
General disorders
Pyrexia	1/8 (12.5%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		2/34 (5.9%)
Disease progression	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		2/34 (5.9%)
Hepatobiliary disorders
Hepatitis	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		2/34 (5.9%)
Autoimmune hepatitis	0/8 (0%)		0/6 (0%)		3/16 (18.8%)		0/7 (0%)		0/34 (0%)
Infections and infestations
Diverticulitis	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Appendicitis	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Pseudomembranous colitis	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Clostridium difficile colitis	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Diarrhoea infectious	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Pneumonia	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		4/34 (11.8%)
Sepsis	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Injury, poisoning and procedural complications
Hip fracture	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Investigations
Haemoglobin decreased	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Metabolism and nutrition disorders
Dehydration	1/8 (12.5%)		1/6 (16.7%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Hyponatraemia	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		2/34 (5.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Prostate cancer	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Cancer pain	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Nervous system disorders
Spinal cord compression	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Psychiatric disorders
Confusional state	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Mental status changes	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Renal and urinary disorders
Renal failure acute	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		2/34 (5.9%)
Hydronephrosis	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Pulmonary oedema	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Dyspnoea	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Vascular disorders
Orthostatic hypotension	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Hypotension	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Ipilimumab Monotherapy 3 mg/kg		Ipilimumab Monotherapy 5 mg/kg		Ipilimumab Monotherapy 10 mg/kg		Ipilimumab 3 mg/kg + XRT Combination Therapy		Ipilimumab 10 mg/kg + XRT Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/8 (100%)		6/6 (100%)		16/16 (100%)		6/7 (85.7%)		33/34 (97.1%)
Blood and lymphatic system disorders
Anaemia	2/8 (25%)		2/6 (33.3%)		2/16 (12.5%)		1/7 (14.3%)		6/34 (17.6%)
Cardiac disorders
Congestive cardiomyopathy	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Tachycardia	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		1/7 (14.3%)		1/34 (2.9%)
Angina pectoris	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Ear and labyrinth disorders
Vertigo	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Endocrine disorders
Hypophysitis	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Hypopituitarism	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		2/34 (5.9%)
Adrenal insufficiency	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		2/7 (28.6%)		0/34 (0%)
Cushingoid	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Hypothyroidism	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Euthyroid sick syndrome	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Hyperthyroidism	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		0/34 (0%)
Eye disorders
Conjunctival haemorrhage	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Conjunctivitis	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Dry eye	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Eye pain	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		1/34 (2.9%)
Eye pruritus	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Vision blurred	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Gastrointestinal disorders
Abdominal pain	1/8 (12.5%)		3/6 (50%)		3/16 (18.8%)		1/7 (14.3%)		3/34 (8.8%)
Gingival bleeding	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Constipation	1/8 (12.5%)		1/6 (16.7%)		6/16 (37.5%)		3/7 (42.9%)		11/34 (32.4%)
Vomiting	3/8 (37.5%)		0/6 (0%)		5/16 (31.3%)		4/7 (57.1%)		10/34 (29.4%)
Dyspepsia	1/8 (12.5%)		0/6 (0%)		1/16 (6.3%)		1/7 (14.3%)		1/34 (2.9%)
Abdominal discomfort	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Abdominal distension	0/8 (0%)		1/6 (16.7%)		1/16 (6.3%)		0/7 (0%)		2/34 (5.9%)
Gastrooesophageal reflux disease	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		1/7 (14.3%)		0/34 (0%)
Colitis	0/8 (0%)		1/6 (16.7%)		3/16 (18.8%)		0/7 (0%)		4/34 (11.8%)
Diarrhoea	4/8 (50%)		3/6 (50%)		13/16 (81.3%)		3/7 (42.9%)		17/34 (50%)
Proctalgia	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Large intestinal obstruction	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Malabsorption	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Anal fissure	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Flatulence	1/8 (12.5%)		1/6 (16.7%)		1/16 (6.3%)		1/7 (14.3%)		1/34 (2.9%)
Haematochezia	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		3/34 (8.8%)
Nausea	4/8 (50%)		2/6 (33.3%)		8/16 (50%)		4/7 (57.1%)		15/34 (44.1%)
General disorders
Early satiety	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Chest pain	1/8 (12.5%)		0/6 (0%)		2/16 (12.5%)		1/7 (14.3%)		2/34 (5.9%)
Chills	1/8 (12.5%)		1/6 (16.7%)		2/16 (12.5%)		0/7 (0%)		0/34 (0%)
Fatigue	7/8 (87.5%)		5/6 (83.3%)		9/16 (56.3%)		4/7 (57.1%)		19/34 (55.9%)
Mucosal inflammation	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		2/34 (5.9%)
Asthenia	1/8 (12.5%)		1/6 (16.7%)		3/16 (18.8%)		1/7 (14.3%)		7/34 (20.6%)
Oedema	1/8 (12.5%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		1/34 (2.9%)
Malaise	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Oedema peripheral	1/8 (12.5%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		5/34 (14.7%)
Pyrexia	1/8 (12.5%)		2/6 (33.3%)		2/16 (12.5%)		1/7 (14.3%)		4/34 (11.8%)
Infusion related reaction	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Pain	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		1/7 (14.3%)		2/34 (5.9%)
Mucosal exfoliation	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Hepatobiliary disorders
Autoimmune hepatitis	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		1/7 (14.3%)		0/34 (0%)
Infections and infestations
Cystitis	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Upper respiratory tract infection	2/8 (25%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Viral infection	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Bronchitis	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		0/34 (0%)
Infected sebaceous cyst	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Sinusitis	1/8 (12.5%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Candidiasis	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Urinary tract infection	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		2/34 (5.9%)
Diarrhoea infectious	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Folliculitis	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Fungal skin infection	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Nasopharyngitis	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Oral herpes	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Pneumonia	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Injury, poisoning and procedural complications
Adverse event following immunisation	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Stress fracture	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Contusion	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		2/34 (5.9%)
Arthropod sting	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Wrist fracture	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Investigations
Haemoglobin decreased	0/8 (0%)		0/6 (0%)		3/16 (18.8%)		0/7 (0%)		1/34 (2.9%)
Weight increased	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Alanine aminotransferase increased	0/8 (0%)		1/6 (16.7%)		2/16 (12.5%)		1/7 (14.3%)		3/34 (8.8%)
Aspartate aminotransferase increased	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		1/7 (14.3%)		5/34 (14.7%)
Blood lactate dehydrogenase increased	0/8 (0%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		2/34 (5.9%)
Blood phosphorus decreased	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Lipase	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Blood corticotrophin decreased	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Blood creatine increased	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Blood potassium decreased	1/8 (12.5%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Blood alkaline phosphatase increased	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		2/34 (5.9%)
Blood amylase increased	0/8 (0%)		2/6 (33.3%)		0/16 (0%)		0/7 (0%)		2/34 (5.9%)
Blood pressure increased	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Transaminases increased	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		0/34 (0%)
Weight decreased	0/8 (0%)		2/6 (33.3%)		7/16 (43.8%)		5/7 (71.4%)		7/34 (20.6%)
Blood bilirubin increased	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Lipase increased	0/8 (0%)		2/6 (33.3%)		1/16 (6.3%)		0/7 (0%)		2/34 (5.9%)
Liver function test abnormal	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Blood alkaline phosphatase abnormal	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Blood glucose increased	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		0/34 (0%)
Gamma-glutamyltransferase increased	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Rheumatoid factor increased	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Metabolism and nutrition disorders
Decreased appetite	2/8 (25%)		1/6 (16.7%)		6/16 (37.5%)		3/7 (42.9%)		13/34 (38.2%)
Hypoalbuminaemia	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Hyperglycaemia	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Hypochloraemia	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Hypokalaemia	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Dehydration	0/8 (0%)		2/6 (33.3%)		6/16 (37.5%)		0/7 (0%)		2/34 (5.9%)
Hyperuricaemia	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Hypocalcaemia	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Hyponatraemia	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Iron deficiency	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Hypoproteinaemia	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Gout	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Hyperlipidaemia	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Hypomagnesaemia	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Musculoskeletal and connective tissue disorders
Bone pain	2/8 (25%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		3/34 (8.8%)
Musculoskeletal stiffness	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Intervertebral disc disorder	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Pain in extremity	0/8 (0%)		1/6 (16.7%)		1/16 (6.3%)		0/7 (0%)		4/34 (11.8%)
Musculoskeletal discomfort	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Groin pain	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Arthralgia	1/8 (12.5%)		2/6 (33.3%)		2/16 (12.5%)		2/7 (28.6%)		8/34 (23.5%)
Muscle atrophy	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Muscular weakness	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		1/7 (14.3%)		3/34 (8.8%)
Neck pain	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Musculoskeletal chest pain	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		1/7 (14.3%)		4/34 (11.8%)
Musculoskeletal pain	1/8 (12.5%)		1/6 (16.7%)		1/16 (6.3%)		0/7 (0%)		4/34 (11.8%)
Myalgia	1/8 (12.5%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		2/34 (5.9%)
Muscle spasms	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Back pain	1/8 (12.5%)		0/6 (0%)		4/16 (25%)		1/7 (14.3%)		6/34 (17.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain	1/8 (12.5%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Nervous system disorders
Paraesthesia	0/8 (0%)		1/6 (16.7%)		2/16 (12.5%)		1/7 (14.3%)		2/34 (5.9%)
Dizziness	0/8 (0%)		1/6 (16.7%)		1/16 (6.3%)		1/7 (14.3%)		2/34 (5.9%)
Neuropathy peripheral	1/8 (12.5%)		0/6 (0%)		2/16 (12.5%)		1/7 (14.3%)		2/34 (5.9%)
Sciatica	1/8 (12.5%)		1/6 (16.7%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Dysgeusia	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		2/34 (5.9%)
Headache	0/8 (0%)		1/6 (16.7%)		1/16 (6.3%)		1/7 (14.3%)		3/34 (8.8%)
Hyperaesthesia	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Hyporeflexia	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Hypoaesthesia	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		2/34 (5.9%)
Restless legs syndrome	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Psychiatric disorders
Confusional state	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Depression	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Affect lability	0/8 (0%)		1/6 (16.7%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Dysphoria	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Hallucination	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Anxiety	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		1/7 (14.3%)		1/34 (2.9%)
Insomnia	2/8 (25%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		6/34 (17.6%)
Panic attack	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Renal and urinary disorders
Azotaemia	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Nocturia	2/8 (25%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Renal impairment	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Incontinence	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Haematuria	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		2/34 (5.9%)
Hydronephrosis	1/8 (12.5%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Reproductive system and breast disorders
Pelvic pain	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Sexual dysfunction	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Gynaecomastia	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Penis disorder	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		5/34 (14.7%)
Postnasal drip	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Dyspnoea	1/8 (12.5%)		2/6 (33.3%)		1/16 (6.3%)		1/7 (14.3%)		5/34 (14.7%)
Wheezing	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)
Dyspnoea exertional	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Oropharyngeal pain	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		0/34 (0%)
Skin and subcutaneous tissue disorders
Rash pruritic	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		1/7 (14.3%)		1/34 (2.9%)
Night sweats	0/8 (0%)		0/6 (0%)		2/16 (12.5%)		0/7 (0%)		0/34 (0%)
Rash	2/8 (25%)		3/6 (50%)		10/16 (62.5%)		1/7 (14.3%)		7/34 (20.6%)
Rash maculo-papular	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Pruritus generalised	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Yellow skin	0/8 (0%)		1/6 (16.7%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Rash papular	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		1/34 (2.9%)
Hyperhidrosis	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Rash erythematous	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Dermatitis acneiform	1/8 (12.5%)		0/6 (0%)		0/16 (0%)		0/7 (0%)		0/34 (0%)
Pruritus	3/8 (37.5%)		1/6 (16.7%)		6/16 (37.5%)		0/7 (0%)		4/34 (11.8%)
Surgical and medical procedures
Tooth extraction	0/8 (0%)		0/6 (0%)		0/16 (0%)		1/7 (14.3%)		0/34 (0%)
Vascular disorders
Hot flush	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		0/34 (0%)
Hypotension	0/8 (0%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		2/34 (5.9%)
Hypertension	1/8 (12.5%)		0/6 (0%)		1/16 (6.3%)		0/7 (0%)		1/34 (2.9%)

Limitations/Caveats

Due to the small number of participants who underwent more than 4 doses of treatment (induction period) and the exploratory nature of this study, not all of the secondary objectives were completed.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Results Point of Contact

Name/Title	Bristol-Myers Squibb Study Director
Organization	Bristol-Myers Squibb
Phone
Email	Clinical.Trials@bms.com

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00323882

Other Study ID Numbers:

CA184-017 ST
CA184-017

First Posted:

May 10, 2006

Last Update Posted:

Aug 28, 2014

Last Verified:

Aug 1, 2014

Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

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Certain Agreements

Results Point of Contact