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

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ClinicalTrials.gov Identifier: NCT00323882
Recruitment Status : Completed
First Posted : May 10, 2006
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Cancer
Neoplasm Metastasis
Intervention Drug: MDX-010
Enrollment 75
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 Details 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
Hide 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
Reason Not Completed
Adverse Event             2             1             1             1             3
Disease Progression             6             4             10             5             22
Death             0             1             1             0             5
Lost to Follow-up             0             0             1             0             1
Not Specified             0             0             0             1             1
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
Hide 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 Number of Baseline Participants 8 6 16 7 34 71
Hide Baseline Analysis Population Description
All participants who received at least one dose of study therapy.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 16 participants 7 participants 34 participants 71 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 16 participants 7 participants 34 participants 71 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
6
 100.0%
16
 100.0%
7
 100.0%
34
 100.0%
71
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 16 participants 7 participants 34 participants 71 participants
Asian 0 0 0 0 1 1
Black 0 0 0 1 3 4
White 8 6 16 6 30 66
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 6 participants 16 participants 7 participants 34 participants 71 participants
8 6 16 7 34 71
Mean Prostate-Specific Antigen (PSA) in ng/mL   [1] 
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 8 participants 6 participants 16 participants 7 participants 34 participants 71 participants
121.6  (140.2) 48.8  (43.9) 302.7  (521.2) 66.6  (68.1) 250.1  (324.1) 212.9  (346.5)
[1]
Measure Description: PSA is measured in nanograms per milliliter (ng/mL).
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 16 participants 7 participants 34 participants 71 participants
ECOG PS 0 5 5 10 4 9 33
ECOG PS 1 3 1 6 2 22 34
ECOG PS 2 0 0 0 1 0 1
ECOG PS Not Reported 0 0 0 0 3 3
[1]
Measure Description: ECOG performance: 0= Fully active, able to carry on all pre-disease performance without restriction;1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or Chair; 5=Dead
1.Primary Outcome
Title Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 6 16 7 34
Measure Type: Number
Unit of Measure: participants
SAE 3 2 9 2 19
Drug-Related SAE 2 1 7 2 7
AEs leading to discontinuation 2 2 7 3 13
Related-AEs leading to discontinuation 2 2 6 3 8
Grade 3-4 AE 2 5 12 3 20
Related AE (Any Grade) 8 5 16 6 29
Grade 3-4 Related AE 2 3 10 3 13
irAE (Any Grade) 6 5 16 4 24
Grade 3-4 irAE 1 3 10 3 6
2.Primary Outcome
Title Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 6 16 6 34
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0 1 0 1
Partial Response 1 1 2 0 3
Unconfirmed Partial Response 0 0 2 0 1
Stable Disease 4 4 7 4 14
Progressive Disease 3 1 3 2 11
Unknown 0 0 1 0 4
3.Secondary Outcome
Title Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 6 16 6 34
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0 0 1 0 2
Partial Response (PR) 2 1 3 2 2
Unconfirmed Partial Response 0 0 2 0 2
Stable Disease (SD) 3 4 6 2 14
Progressive Disease (PD) 3 1 3 2 11
Unknown 0 0 1 0 3
4.Secondary Outcome
Title Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1 1 8 2 20
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0 1 0 0
Partial Response 0 0 0 0 0
Unconfirmed Partial Response 0 0 1 0 1
Stable Disease 1 1 1 1 5
Progressive Disease 0 0 3 1 5
Unknown 0 0 2 0 9
5.Secondary Outcome
Title Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 1 1 3 0 2 2
Median (Full Range)
Unit of Measure: Months
1.41
(1.41 to 1.41)
1.54
(1.54 to 1.54)
1.4
(0.9 to 2.3)
1.1
(0.8 to 1.5)
1.1
(0.8 to 1.4)
6.Secondary Outcome
Title Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 8 16 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.5
(0.3 to 52.7)
0
(0 to 0)
0
(0 to 0)
7.Secondary Outcome
Title PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 16 21 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PSA Response Rate at Day 85
18.8
(4.0 to 45.6)
9.5
(1.2 to 30.4)
15.4
(1.9 to 45.4)
Overall PSA Response Rate
25.0
(7.3 to 52.4)
9.5
(1.2 to 30.4)
15.4
(1.9 to 45.4)
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 6 16 7 34 71
Measure Type: Number
Unit of Measure: participants
Total Deaths at Primary Analysis 5 4 7 3 18 37
Maliginant Disease 0 0 0 0 3 3
Prostate Cancer 1 3 4 3 10 21
Toxicity 0 1 0 0 0 1
Other 0 0 0 0 2 2
Unknown 3 0 3 0 3 9
No cause specified 1 0 0 0 0 1
Total Deaths at Completion of Follow Up 7 6 11 7 29 60
Malignant Disease 0 0 0 0 3 3
Prostate Cancer 1 4 6 4 13 28
Toxicity 0 1 0 0 0 1
Other 0 1 1 0 5 7
Unknown 5 0 4 3 8 20
No cause specified 1 0 0 0 0 1
9.Secondary Outcome
Title Overall Survival at Completion of Follow Up Period - Treated Participants
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 6 16 7 34 71
Median (95% Confidence Interval)
Unit of Measure: Months
22.5
(11.5 to 59.9)
36.3
(28.0 to 41.8)
26.6
(8.6 to 49.9)
18.2
(10.0 to 24.7)
9.7
(5.6 to 16.4)
17.4
(11.5 to 24.7)
10.Secondary Outcome
Title Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 5 15 6 34
Measure Type: Number
Unit of Measure: participants
WBC Grade 1-4 (n=8, 5, 15, 6, 34) 0 0 0 1 2
WBC Grade 3-4 (n=8, 5, 15, 6, 34) 0 0 0 0 0
Neutrophils Grade 1-4 (n=8, 5, 15, 6, 34) 2 0 0 1 2
Neutrophils Grade 3-4 (n=8, 5, 15, 6, 34) 0 0 0 0 0
Platelets Grade 1-4 (n=8, 5, 15, 6, 34) 0 0 1 1 2
Platelets Grade 3-4 (n=8, 5, 15, 6, 34) 0 0 0 0 0
Hemoglobin Grade 1-4 (n=8, 5, 15, 6, 34) 7 4 12 6 28
Hemoglobin Grade 3-4 (n=8, 5, 15, 6, 34) 0 0 1 0 6
Lymphocytes Grade 1-4 (n=8, 5, 15, 6, 34) 7 3 12 5 31
Lymphocytes Grade 3-4 (n=8, 5, 15, 6, 34) 0 0 2 1 3
11.Secondary Outcome
Title Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants
Hide 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 - 1.5*ULN; Gr2: > 1.5 - 3.0*ULN; Gr3: > 3.0 - 6.0*ULN; Gr4: > 6.0*ULN.
Time Frame Day 1 to last day of study treatment (+70 days) up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 5 15 6 34
Measure Type: Number
Unit of Measure: participants
ALT Grade 1-4 (n=8,5,15,6,34) 0 2 7 2 10
ALT Grade 3-4 (n=8,5,15,6,34) 0 1 2 0 1
AST Grade 1-4 (n=8,5,15,6,34) 0 2 6 2 8
AST Grade 3-4 (n=8,5,15,6,34) 0 1 2 0 0
Bilirubin Grade 1-4 (n=8,5,15,6,34) 0 0 2 1 1
Bilirubin Grade 3-4 (n=8,5,15,6,34) 0 0 0 0 0
Phosphatase Grade 1-4 (n=8,5,15,6,34) 3 4 7 5 21
Phosphatase Grade 3-4 (n=8,5,15,6,34) 0 0 1 1 5
Amylase Grade 1-4 (n=8,5,15,6,34) 2 3 4 0 4
Amylase Grade 3-4 (n=8,5,15,6,34) 0 0 0 0 1
Creatinine Grade 1-4 (n=8,5,15,6,34) 0 0 4 1 5
Creatinine Grade 3-4 (n=8,5,15,6,34) 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 6 15 7 31
Measure Type: Number
Unit of Measure: participants
ECG Abnormalities at Baseline (n=8, 6, 15, 7, 31) 0 0 2 0 0
ECG Abnormalities During Treatment (n=4,3,11,4,20) 0 0 2 0 0
13.Secondary Outcome
Title Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 6 16 7 34
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
Time Frame Day 1 to last day of study treatment (+70 days) up to 2 years
Adverse Event Reporting Description [Not Specified]
 
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
Hide 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
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/8 (37.50%)   2/6 (33.33%)   9/16 (56.25%)   2/7 (28.57%)   19/34 (55.88%) 
Blood and lymphatic system disorders           
Anaemia  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  1/7 (14.29%)  2/34 (5.88%) 
Lymphadenopathy  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Thrombocytopenia  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Cardiac disorders           
Acute myocardial infarction  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Atrial fibrillation  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Cardio-respiratory arrest  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Atrial flutter  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Congenital, familial and genetic disorders           
Gastrointestinal angiodysplasia haemorrhagic  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Endocrine disorders           
Hypophysitis  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Hypopituitarism  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Secondary adrenocortical insufficiency  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Hyperthyroidism  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  0/34 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Abdominal pain upper  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Vomiting  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  2/34 (5.88%) 
Colitis  1  1/8 (12.50%)  1/6 (16.67%)  4/16 (25.00%)  1/7 (14.29%)  2/34 (5.88%) 
Diarrhoea  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  1/7 (14.29%)  1/34 (2.94%) 
Ascites  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Gastrointestinal haemorrhage  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Haematochezia  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Nausea  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  2/34 (5.88%) 
General disorders           
Pyrexia  1  1/8 (12.50%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  2/34 (5.88%) 
Disease progression  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  2/34 (5.88%) 
Hepatobiliary disorders           
Hepatitis  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  2/34 (5.88%) 
Autoimmune hepatitis  1  0/8 (0.00%)  0/6 (0.00%)  3/16 (18.75%)  0/7 (0.00%)  0/34 (0.00%) 
Infections and infestations           
Diverticulitis  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Appendicitis  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Pseudomembranous colitis  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Clostridium difficile colitis  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Diarrhoea infectious  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Pneumonia  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  4/34 (11.76%) 
Sepsis  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Injury, poisoning and procedural complications           
Hip fracture  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Investigations           
Haemoglobin decreased  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Metabolism and nutrition disorders           
Dehydration  1  1/8 (12.50%)  1/6 (16.67%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Hyponatraemia  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  2/34 (5.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Spinal cord neoplasm  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Prostate cancer  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Cancer pain  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Nervous system disorders           
Spinal cord compression  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Psychiatric disorders           
Confusional state  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Mental status changes  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Renal and urinary disorders           
Renal failure acute  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  2/34 (5.88%) 
Hydronephrosis  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Respiratory, thoracic and mediastinal disorders           
Pleural effusion  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Pulmonary oedema  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Dyspnoea  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Vascular disorders           
Orthostatic hypotension  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Hypotension  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   6/6 (100.00%)   16/16 (100.00%)   6/7 (85.71%)   33/34 (97.06%) 
Blood and lymphatic system disorders           
Anaemia  1  2/8 (25.00%)  2/6 (33.33%)  2/16 (12.50%)  1/7 (14.29%)  6/34 (17.65%) 
Cardiac disorders           
Congestive cardiomyopathy  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Tachycardia  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  1/7 (14.29%)  1/34 (2.94%) 
Angina pectoris  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Ear and labyrinth disorders           
Vertigo  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Endocrine disorders           
Hypophysitis  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Hypopituitarism  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  2/34 (5.88%) 
Adrenal insufficiency  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  2/7 (28.57%)  0/34 (0.00%) 
Cushingoid  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Hypothyroidism  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Euthyroid sick syndrome  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Hyperthyroidism  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  0/34 (0.00%) 
Eye disorders           
Conjunctival haemorrhage  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Conjunctivitis  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Dry eye  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Eye pain  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  1/34 (2.94%) 
Eye pruritus  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Vision blurred  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  1/8 (12.50%)  3/6 (50.00%)  3/16 (18.75%)  1/7 (14.29%)  3/34 (8.82%) 
Gingival bleeding  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Constipation  1  1/8 (12.50%)  1/6 (16.67%)  6/16 (37.50%)  3/7 (42.86%)  11/34 (32.35%) 
Vomiting  1  3/8 (37.50%)  0/6 (0.00%)  5/16 (31.25%)  4/7 (57.14%)  10/34 (29.41%) 
Dyspepsia  1  1/8 (12.50%)  0/6 (0.00%)  1/16 (6.25%)  1/7 (14.29%)  1/34 (2.94%) 
Abdominal discomfort  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Abdominal distension  1  0/8 (0.00%)  1/6 (16.67%)  1/16 (6.25%)  0/7 (0.00%)  2/34 (5.88%) 
Gastrooesophageal reflux disease  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  1/7 (14.29%)  0/34 (0.00%) 
Colitis  1  0/8 (0.00%)  1/6 (16.67%)  3/16 (18.75%)  0/7 (0.00%)  4/34 (11.76%) 
Diarrhoea  1  4/8 (50.00%)  3/6 (50.00%)  13/16 (81.25%)  3/7 (42.86%)  17/34 (50.00%) 
Proctalgia  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Large intestinal obstruction  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Malabsorption  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Anal fissure  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Flatulence  1  1/8 (12.50%)  1/6 (16.67%)  1/16 (6.25%)  1/7 (14.29%)  1/34 (2.94%) 
Haematochezia  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  3/34 (8.82%) 
Nausea  1  4/8 (50.00%)  2/6 (33.33%)  8/16 (50.00%)  4/7 (57.14%)  15/34 (44.12%) 
General disorders           
Early satiety  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Chest pain  1  1/8 (12.50%)  0/6 (0.00%)  2/16 (12.50%)  1/7 (14.29%)  2/34 (5.88%) 
Chills  1  1/8 (12.50%)  1/6 (16.67%)  2/16 (12.50%)  0/7 (0.00%)  0/34 (0.00%) 
Fatigue  1  7/8 (87.50%)  5/6 (83.33%)  9/16 (56.25%)  4/7 (57.14%)  19/34 (55.88%) 
Mucosal inflammation  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  2/34 (5.88%) 
Asthenia  1  1/8 (12.50%)  1/6 (16.67%)  3/16 (18.75%)  1/7 (14.29%)  7/34 (20.59%) 
Oedema  1  1/8 (12.50%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  1/34 (2.94%) 
Malaise  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Oedema peripheral  1  1/8 (12.50%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  5/34 (14.71%) 
Pyrexia  1  1/8 (12.50%)  2/6 (33.33%)  2/16 (12.50%)  1/7 (14.29%)  4/34 (11.76%) 
Infusion related reaction  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Pain  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  1/7 (14.29%)  2/34 (5.88%) 
Mucosal exfoliation  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Hepatobiliary disorders           
Autoimmune hepatitis  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  1/7 (14.29%)  0/34 (0.00%) 
Infections and infestations           
Cystitis  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Upper respiratory tract infection  1  2/8 (25.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Viral infection  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Bronchitis  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  0/34 (0.00%) 
Infected sebaceous cyst  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Sinusitis  1  1/8 (12.50%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Candidiasis  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Urinary tract infection  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  2/34 (5.88%) 
Diarrhoea infectious  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Folliculitis  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Fungal skin infection  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Nasopharyngitis  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Oral herpes  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Pneumonia  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Injury, poisoning and procedural complications           
Adverse event following immunisation  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Stress fracture  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Contusion  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  2/34 (5.88%) 
Arthropod sting  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Wrist fracture  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Investigations           
Haemoglobin decreased  1  0/8 (0.00%)  0/6 (0.00%)  3/16 (18.75%)  0/7 (0.00%)  1/34 (2.94%) 
Weight increased  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Alanine aminotransferase increased  1  0/8 (0.00%)  1/6 (16.67%)  2/16 (12.50%)  1/7 (14.29%)  3/34 (8.82%) 
Aspartate aminotransferase increased  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  1/7 (14.29%)  5/34 (14.71%) 
Blood lactate dehydrogenase increased  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  2/34 (5.88%) 
Blood phosphorus decreased  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Lipase  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Blood corticotrophin decreased  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Blood creatine increased  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Blood potassium decreased  1  1/8 (12.50%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Blood alkaline phosphatase increased  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  2/34 (5.88%) 
Blood amylase increased  1  0/8 (0.00%)  2/6 (33.33%)  0/16 (0.00%)  0/7 (0.00%)  2/34 (5.88%) 
Blood pressure increased  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Transaminases increased  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  0/34 (0.00%) 
Weight decreased  1  0/8 (0.00%)  2/6 (33.33%)  7/16 (43.75%)  5/7 (71.43%)  7/34 (20.59%) 
Blood bilirubin increased  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Lipase increased  1  0/8 (0.00%)  2/6 (33.33%)  1/16 (6.25%)  0/7 (0.00%)  2/34 (5.88%) 
Liver function test abnormal  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Blood alkaline phosphatase abnormal  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Blood glucose increased  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  0/34 (0.00%) 
Gamma-glutamyltransferase increased  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Rheumatoid factor increased  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite  1  2/8 (25.00%)  1/6 (16.67%)  6/16 (37.50%)  3/7 (42.86%)  13/34 (38.24%) 
Hypoalbuminaemia  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Hyperglycaemia  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Hypochloraemia  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Hypokalaemia  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Dehydration  1  0/8 (0.00%)  2/6 (33.33%)  6/16 (37.50%)  0/7 (0.00%)  2/34 (5.88%) 
Hyperuricaemia  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Hypocalcaemia  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Hyponatraemia  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Iron deficiency  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Hypoproteinaemia  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Gout  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Hyperlipidaemia  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Hypomagnesaemia  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Musculoskeletal and connective tissue disorders           
Bone pain  1  2/8 (25.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  3/34 (8.82%) 
Musculoskeletal stiffness  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Intervertebral disc disorder  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Pain in extremity  1  0/8 (0.00%)  1/6 (16.67%)  1/16 (6.25%)  0/7 (0.00%)  4/34 (11.76%) 
Musculoskeletal discomfort  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Groin pain  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Arthralgia  1  1/8 (12.50%)  2/6 (33.33%)  2/16 (12.50%)  2/7 (28.57%)  8/34 (23.53%) 
Muscle atrophy  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Muscular weakness  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  1/7 (14.29%)  3/34 (8.82%) 
Neck pain  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Musculoskeletal chest pain  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  1/7 (14.29%)  4/34 (11.76%) 
Musculoskeletal pain  1  1/8 (12.50%)  1/6 (16.67%)  1/16 (6.25%)  0/7 (0.00%)  4/34 (11.76%) 
Myalgia  1  1/8 (12.50%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  2/34 (5.88%) 
Muscle spasms  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Back pain  1  1/8 (12.50%)  0/6 (0.00%)  4/16 (25.00%)  1/7 (14.29%)  6/34 (17.65%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Metastatic pain  1  1/8 (12.50%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Nervous system disorders           
Paraesthesia  1  0/8 (0.00%)  1/6 (16.67%)  2/16 (12.50%)  1/7 (14.29%)  2/34 (5.88%) 
Dizziness  1  0/8 (0.00%)  1/6 (16.67%)  1/16 (6.25%)  1/7 (14.29%)  2/34 (5.88%) 
Neuropathy peripheral  1  1/8 (12.50%)  0/6 (0.00%)  2/16 (12.50%)  1/7 (14.29%)  2/34 (5.88%) 
Sciatica  1  1/8 (12.50%)  1/6 (16.67%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Dysgeusia  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  2/34 (5.88%) 
Headache  1  0/8 (0.00%)  1/6 (16.67%)  1/16 (6.25%)  1/7 (14.29%)  3/34 (8.82%) 
Hyperaesthesia  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Hyporeflexia  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Hypoaesthesia  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  2/34 (5.88%) 
Restless legs syndrome  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Psychiatric disorders           
Confusional state  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Depression  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Affect lability  1  0/8 (0.00%)  1/6 (16.67%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Dysphoria  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Hallucination  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Anxiety  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  1/7 (14.29%)  1/34 (2.94%) 
Insomnia  1  2/8 (25.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  6/34 (17.65%) 
Panic attack  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Renal and urinary disorders           
Azotaemia  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Nocturia  1  2/8 (25.00%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Renal impairment  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Incontinence  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Haematuria  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  2/34 (5.88%) 
Hydronephrosis  1  1/8 (12.50%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Reproductive system and breast disorders           
Pelvic pain  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Sexual dysfunction  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Gynaecomastia  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Penis disorder  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  5/34 (14.71%) 
Postnasal drip  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Dyspnoea  1  1/8 (12.50%)  2/6 (33.33%)  1/16 (6.25%)  1/7 (14.29%)  5/34 (14.71%) 
Wheezing  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Dyspnoea exertional  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Oropharyngeal pain  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  0/34 (0.00%) 
Skin and subcutaneous tissue disorders           
Rash pruritic  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  1/7 (14.29%)  1/34 (2.94%) 
Night sweats  1  0/8 (0.00%)  0/6 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  0/34 (0.00%) 
Rash  1  2/8 (25.00%)  3/6 (50.00%)  10/16 (62.50%)  1/7 (14.29%)  7/34 (20.59%) 
Rash maculo-papular  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Pruritus generalised  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Yellow skin  1  0/8 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Rash papular  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/34 (2.94%) 
Hyperhidrosis  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Rash erythematous  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Dermatitis acneiform  1  1/8 (12.50%)  0/6 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/34 (0.00%) 
Pruritus  1  3/8 (37.50%)  1/6 (16.67%)  6/16 (37.50%)  0/7 (0.00%)  4/34 (11.76%) 
Surgical and medical procedures           
Tooth extraction  1  0/8 (0.00%)  0/6 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/34 (0.00%) 
Vascular disorders           
Hot flush  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/34 (0.00%) 
Hypotension  1  0/8 (0.00%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  2/34 (5.88%) 
Hypertension  1  1/8 (12.50%)  0/6 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/34 (2.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00323882     History of Changes
Other Study ID Numbers: CA184-017 ST
CA184-017 ( Other Identifier: BMS )
First Submitted: May 8, 2006
First Posted: May 10, 2006
Results First Submitted: July 23, 2014
Results First Posted: August 28, 2014
Last Update Posted: August 28, 2014