Study of MDX-010 in Patients With Metastatic Hormone-Refr... | NCT00323882 | Trialant
NCT00323882
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Aug 28, 2014Estimated
Enrollment
75Actual
Phase
Phase 1Phase 2
Conditions
Prostate Cancer
Neoplasm Metastasis
Interventions
MDX-010
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00323882
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA184-017 ST
Secondary IDs
ID
Type
Description
Link
CA184-017
Other Identifier
BMS
Brief Title
Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer
Official Title
A Phase I/II, Open-label, Dose-escalation Study of MDX-010 Administered Every 3 Weeks for 4 Doses in Patients With Metastatic Hormone-Refractory Prostate Cancer
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Aug 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2006
Primary Completion Date
Sep 2009Actual
Completion Date
Jul 2013Actual
First Submitted Date
May 8, 2006
First Submission Date that Met QC Criteria
May 8, 2006
First Posted Date
May 10, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 23, 2014
Results First Submitted that Met QC Criteria
Aug 14, 2014
Results First Posted Date
Aug 28, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 29, 2011
Certification/Extension First Submitted that Passed QC Review
Nov 4, 2011
Certification/Extension First Posted Date
Nov 10, 2011Estimated
Last Update Submitted Date
Aug 14, 2014
Last Update Posted Date
Aug 28, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.
Detailed Description
Not provided
Conditions Module
Conditions
Prostate Cancer
Neoplasm Metastasis
Keywords
Prostate Cancer
Oncology
Prostate
Cancer
Metastatic
Hormone
PSA
Metastatic Hormone-Refractory Prostate Cancer (HRPC)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
75Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MDX-010
Experimental
Drug: MDX-010
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MDX-010
Drug
selected dose administered IV every 3 weeks
MDX-010
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants
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.
Day 1 to last day of study treatment (+70 days) up to 2 years
Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants
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.
Day 85
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologic diagnosis of adenocarcinoma of the prostate
Metastatic prostate cancer (positive bone scan or measurable disease)
Total testosterone of less than 50 ng/dL, except for patients with prior orchiectomy, where testosterone does not need to be measured.
Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen and completion of a washout period and then observe disease progression.
Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products.
Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required.
Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.
No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
Exclusion Criteria:
Bone pain due to metastatic bone disease severe enough to require routine narcotic analgesic use.
History of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo.
Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.
Active infection requiring therapy.
Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.
Sun BL. Immunotherapy in treatment of metastatic prostate cancer: An approach to circumvent immunosuppressive tumor microenvironment. Prostate. 2021 Nov;81(15):1125-1134. doi: 10.1002/pros.24213. Epub 2021 Aug 26.
Iwama S, De Remigis A, Callahan MK, Slovin SF, Wolchok JD, Caturegli P. Pituitary expression of CTLA-4 mediates hypophysitis secondary to administration of CTLA-4 blocking antibody. Sci Transl Med. 2014 Apr 2;6(230):230ra45. doi: 10.1126/scitranslmed.3008002.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
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.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ipilimumab Monotherapy 3 mg/kg
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Day 1 to last day of study treatment (+70 days) up to 2 years
Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants
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.
Day 1 to last day of study treatment (+70 days) up to 2 years
Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85
Time to PSA response was measured in months. Time to PSA response was analyzed in those participants with CR or PR at Day 85. CR=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value.
Day 1 to Day 85
Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy
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
Day 1 to last day of study treatment (+70 days) up to 2 years
PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy
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.
Day 85, Day 1 to last day of study treatment (+70 days) up to 2 years
Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants
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.
Day 1 to 5 years post treatment
Overall Survival at Completion of Follow Up Period - Treated Participants
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.
Day 1 to 5 years post treatment
Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants
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.
Day 1 to last day of study treatment (+70 days) up to 2 years
Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants
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.
Day 1 to last day of study treatment (+70 days) up to 2 years
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants
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).
Baseline up to 2 years
Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants
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.
Day 1 up to 2 years
Los Angeles
California
90025
United States
UCSF Helen Diller Family Comprehensive Cancer Center
Slovin SF, Higano CS, Hamid O, Tejwani S, Harzstark A, Alumkal JJ, Scher HI, Chin K, Gagnier P, McHenry MB, Beer TM. Ipilimumab alone or in combination with radiotherapy in metastatic castration-resistant prostate cancer: results from an open-label, multicenter phase I/II study. Ann Oncol. 2013 Jul;24(7):1813-1821. doi: 10.1093/annonc/mdt107. Epub 2013 Mar 27.
FG001
Ipilimumab Monotherapy 5 mg/kg
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.
FG002
Ipilimumab Monotherapy 10 mg/kg
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.
FG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
FG004
Ipilimumab 10 mg/kg + XRT Combination
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.
FG0008 subjects
FG0016 subjects
FG00216 subjects
FG0037 subjects
FG00434 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0042 subjects
NOT COMPLETED
FG0008 subjects
FG0016 subjects
FG00213 subjects
FG0037 subjects
FG00432 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0043 subjects
Disease Progression
FG0006 subjects
FG0014 subjects
FG00210 subjects
FG0035 subjects
FG004
Death
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
All participants who received at least one dose of study therapy.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ipilimumab Monotherapy 3 mg/kg
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.
BG001
Ipilimumab Monotherapy 5 mg/kg
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.
BG002
Ipilimumab Monotherapy 10 mg/kg
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.
BG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
BG004
Ipilimumab 10 mg/kg + XRT Combination
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.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0016
BG00216
BG0037
BG00434
BG00571
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00068.0± 8.1
BG00158.2± 5.6
BG00265.2± 7.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0008
BG0016
BG002
Mean Prostate-Specific Antigen (PSA) in ng/mL
PSA is measured in nanograms per milliliter (ng/mL).
Mean
Standard Deviation
ng/mL
Title
Denominators
Categories
Title
Measurements
BG000121.6± 140.2
BG00148.8± 43.9
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
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
Number
participants
Title
Denominators
Categories
ECOG PS 0
Title
Measurements
BG0005
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants
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.
All participants in the study who received either ipilimumab or radiation were analyzed.
Posted
Number
participants
Day 1 to last day of study treatment (+70 days) up to 2 years
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG003
Title
Denominators
Categories
SAE
Title
Measurements
OG0003
OG0012
OG0029
OG003
Secondary
Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants
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.
PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.
Posted
Number
participants
Day 1 to last day of study treatment (+70 days) up to 2 years
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
Secondary
Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants
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.
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.
Posted
Number
participants
Day 1 to last day of study treatment (+70 days) up to 2 years
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
Secondary
Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85
Time to PSA response was measured in months. Time to PSA response was analyzed in those participants with CR or PR at Day 85. CR=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value.
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.
Posted
Median
Full Range
Months
Day 1 to Day 85
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
Secondary
Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy
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
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.
Posted
Number
95% Confidence Interval
percentage of participants
Day 1 to last day of study treatment (+70 days) up to 2 years
ID
Title
Description
OG000
Ipilimumab Monotherapy 10 mg/kg
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.
PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Day 85, Day 1 to last day of study treatment (+70 days) up to 2 years
ID
Title
Description
OG000
Ipilimumab Monotherapy 10 mg/kg
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.
Primary
Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants
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.
PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.
Posted
Number
participants
Day 85
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
Secondary
Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants
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.
Treated participants population included all participants in the study who received either ipilimumab or radiation.
Posted
Number
participants
Day 1 to 5 years post treatment
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
Secondary
Overall Survival at Completion of Follow Up Period - Treated Participants
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.
All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab were analyzed.
Posted
Median
95% Confidence Interval
Months
Day 1 to 5 years post treatment
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
Secondary
Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants
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.
All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.
Posted
Number
participants
Day 1 to last day of study treatment (+70 days) up to 2 years
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
Secondary
Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants
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.
All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.
Posted
Number
participants
Day 1 to last day of study treatment (+70 days) up to 2 years
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
Secondary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants
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).
All participants in the study who received either ipilimumab or radiation and had an ECG were analyzed.
Posted
Number
participants
Baseline up to 2 years
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
Secondary
Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants
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.
All participants in the study who received either ipilimumab or radiation and had a measurement were analyzed.
Posted
Number
participants
Day 1 up to 2 years
ID
Title
Description
OG000
Ipilimumab Monotherapy 3 mg/kg
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.
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
Time Frame
Day 1 to last day of study treatment (+70 days) up to 2 years
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Ipilimumab Monotherapy 3 mg/kg
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.
3
8
8
8
EG001
Ipilimumab Monotherapy 5 mg/kg
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.
2
6
6
6
EG002
Ipilimumab Monotherapy 10 mg/kg
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.
9
16
16
16
EG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
2
7
6
7
EG004
Ipilimumab 10 mg/kg + XRT Combination
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.
19
34
33
34
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG0031 affected7 at risk
EG0040 affected34 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Secondary adrenocortical insufficiency
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0021 affected16 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0023 affected16 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hypotension
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Spinal cord neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Pyrexia
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0024 affected16 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Gastrointestinal angiodysplasia haemorrhagic
Congenital, familial and genetic disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Pseudomembranous colitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Disease progression
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Sepsis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0013 affected6 at risk
EG0023 affected16 at risk
EG0031 affected7 at risk
EG0043 affected34 at risk
Adverse event following immunisation
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Cystitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected8 at risk
EG0011 affected6 at risk
EG0026 affected16 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Early satiety
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0023 affected16 at risk
EG003
Hot flush
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Metastatic pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0022 affected16 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Viral infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0021 affected16 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected8 at risk
EG0012 affected6 at risk
EG0022 affected16 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Chest pain
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Congestive cardiomyopathy
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0026 affected16 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0021 affected16 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected8 at risk
EG0013 affected6 at risk
EG00210 affected16 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0003 affected8 at risk
EG0010 affected6 at risk
EG0025 affected16 at risk
EG003
Weight increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0022 affected16 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Chills
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0022 affected16 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected6 at risk
EG0026 affected16 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Dysphoria
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Fatigue
General disorders
MedDRA 13.0
Systematic Assessment
EG0007 affected8 at risk
EG0015 affected6 at risk
EG0029 affected16 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Infected sebaceous cyst
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Lipase
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0021 affected16 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Asthenia
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0023 affected16 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Blood corticotrophin decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Blood creatine increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0021 affected16 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected6 at risk
EG0021 affected16 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Hypotension
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Oedema
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0021 affected16 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Yellow skin
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected6 at risk
EG0022 affected16 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Blood amylase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected6 at risk
EG0020 affected16 at risk
EG003
Blood pressure increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Dry eye
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Malaise
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Oedema peripheral
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Pyrexia
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected6 at risk
EG0022 affected16 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Sexual dysfunction
Reproductive system and breast disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Transaminases increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Weight decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected6 at risk
EG0027 affected16 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0023 affected16 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected8 at risk
EG0013 affected6 at risk
EG00213 affected16 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0021 affected16 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Infusion related reaction
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Lipase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected6 at risk
EG0021 affected16 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0021 affected16 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Pain
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Blood alkaline phosphatase abnormal
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Blood glucose increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Euthyroid sick syndrome
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Eye pain
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Hyporeflexia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Malabsorption
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Mucosal exfoliation
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Penis disorder
Reproductive system and breast disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0024 affected16 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0021 affected16 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0022 affected16 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected8 at risk
EG0012 affected6 at risk
EG0028 affected16 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected16 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0003 affected8 at risk
EG0011 affected6 at risk
EG0026 affected16 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Rheumatoid factor increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected16 at risk
EG003
Vision blurred
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected16 at risk
EG003
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
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Clinical.Trials@bms.com
ID
Term
D011471
Prostatic Neoplasms
D009362
Neoplasm Metastasis
D009369
Neoplasms
Ancestor Terms
ID
Term
D005834
Genital Neoplasms, Male
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D005832
Genital Diseases, Male
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D011469
Prostatic Diseases
D052801
Male Urogenital Diseases
D009385
Neoplastic Processes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000074324
Ipilimumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
22 subjects
5 subjects
1 subjects
1 subjects
67.6
± 8.5
BG00465.7± 9.1
BG00565.4± 8.5
0
BG0030
BG0040
BG0050
Male
BG0008
BG0016
BG00216
BG0037
BG00434
BG00571
0
BG0030
BG0041
BG0051
Black
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0043
BG0054
White
Title
Measurements
BG0008
BG0016
BG00216
BG0036
BG00430
BG00566
16
BG0037
BG00434
BG00571
BG002
302.7
± 521.2
BG00366.6± 68.1
BG004250.1± 324.1
BG005212.9± 346.5
5
BG00210
BG0034
BG0049
BG00533
ECOG PS 1
Title
Measurements
BG0003
BG0011
BG0026
BG0032
BG00422
BG00534
ECOG PS 2
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0040
BG0051
ECOG PS Not Reported
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0043
BG0053
OG004
Ipilimumab 10 mg/kg + XRT Combination
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.
7
OG00434
2
OG00419
Drug-Related SAE
Title
Measurements
OG0002
OG0011
OG0027
OG0032
OG0047
AEs leading to discontinuation
Title
Measurements
OG0002
OG0012
OG0027
OG0033
OG00413
Related-AEs leading to discontinuation
Title
Measurements
OG0002
OG0012
OG0026
OG0033
OG0048
Grade 3-4 AE
Title
Measurements
OG0002
OG0015
OG00212
OG0033
OG00420
Related AE (Any Grade)
Title
Measurements
OG0008
OG0015
OG00216
OG0036
OG00429
Grade 3-4 Related AE
Title
Measurements
OG0002
OG0013
OG00210
OG0033
OG00413
irAE (Any Grade)
Title
Measurements
OG0006
OG0015
OG00216
OG0034
OG00424
Grade 3-4 irAE
Title
Measurements
OG0001
OG0013
OG00210
OG0033
OG0046
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
OG004
Ipilimumab 10 mg/kg + XRT Combination
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.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG0036
OG00434
Title
Denominators
Categories
Complete Response (CR)
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0042
Partial Response (PR)
Title
Measurements
OG0002
OG0011
OG0023
OG003
Unconfirmed Partial Response
Title
Measurements
OG0000
OG0010
OG0022
OG003
Stable Disease (SD)
Title
Measurements
OG0003
OG0014
OG0026
OG003
Progressive Disease (PD)
Title
Measurements
OG0003
OG0011
OG0023
OG003
Unknown
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
OG004
Ipilimumab 10 mg/kg + XRT Combination
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.
Units
Counts
Participants
OG0001
OG0011
OG0028
OG0032
OG00420
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
Partial Response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unconfirmed Partial Response
Title
Measurements
OG0000
OG0010
OG0021
OG003
Stable Disease
Title
Measurements
OG0001
OG0011
OG0021
OG003
Progressive Disease
Title
Measurements
OG0000
OG0010
OG0023
OG003
Unknown
Title
Measurements
OG0000
OG0010
OG0022
OG003
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0030
OG0042
OG0052
Title
Denominators
Categories
Title
Measurements
OG0001.41(1.41 to 1.41)
OG0011.54(1.54 to 1.54)
OG0021.4(0.9 to 2.3)
OG0041.1(0.8 to 1.5)
OG0051.1(0.8 to 1.4)
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.
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.
Units
Counts
Participants
OG00016
OG00121
OG00213
Title
Denominators
Categories
PSA Response Rate at Day 85
Title
Measurements
OG00018.8(4.0 to 45.6)
OG0019.5(1.2 to 30.4)
OG00215.4(1.9 to 45.4)
Overall PSA Response Rate
Title
Measurements
OG00025.0(7.3 to 52.4)
OG0019.5(1.2 to 30.4)
OG00215.4(1.9 to 45.4)
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
OG004
Ipilimumab 10 mg/kg + XRT Combination
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.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG0036
OG00434
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
Partial Response
Title
Measurements
OG0001
OG0011
OG0022
OG003
Unconfirmed Partial Response
Title
Measurements
OG0000
OG0010
OG0022
OG003
Stable Disease
Title
Measurements
OG0004
OG0014
OG0027
OG003
Progressive Disease
Title
Measurements
OG0003
OG0011
OG0023
OG003
Unknown
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
OG004
Ipilimumab 10 mg/kg + XRT Combination
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.
OG005
All Treated Participants
All participants in all treatment arms combined.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG0037
OG00434
OG00571
Title
Denominators
Categories
Total Deaths at Primary Analysis
Title
Measurements
OG0005
OG0014
OG0027
OG0033
OG00418
OG00537
Maliginant Disease
Title
Measurements
OG0000
OG0010
OG0020
OG003
Prostate Cancer
Title
Measurements
OG0001
OG0013
OG0024
OG003
Toxicity
Title
Measurements
OG0000
OG0011
OG0020
OG003
Other
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unknown
Title
Measurements
OG0003
OG0010
OG0023
OG003
No cause specified
Title
Measurements
OG0001
OG0010
OG0020
OG003
Total Deaths at Completion of Follow Up
Title
Measurements
OG0007
OG0016
OG00211
OG003
Malignant Disease
Title
Measurements
OG0000
OG0010
OG0020
OG003
Prostate Cancer
Title
Measurements
OG0001
OG0014
OG0026
OG003
Toxicity
Title
Measurements
OG0000
OG0011
OG0020
OG003
Other
Title
Measurements
OG0000
OG0011
OG0021
OG003
Unknown
Title
Measurements
OG0005
OG0010
OG0024
OG003
No cause specified
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
OG004
Ipilimumab 10 mg/kg + XRT Combination
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.
OG005
All Treated Participants
All treatment groups are combined to show total overall survival at completion of Follow Up.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG0037
OG00434
OG00571
Title
Denominators
Categories
Title
Measurements
OG00022.5(11.5 to 59.9)
OG00136.3(28.0 to 41.8)
OG00226.6(8.6 to 49.9)
OG00318.2(10.0 to 24.7)
OG0049.7(5.6 to 16.4)
OG00517.4(11.5 to 24.7)
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
OG004
Ipilimumab 10 mg/kg + XRT Combination
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.
Units
Counts
Participants
OG0008
OG0015
OG00215
OG0036
OG00434
Title
Denominators
Categories
WBC Grade 1-4 (n=8, 5, 15, 6, 34)
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0042
WBC Grade 3-4 (n=8, 5, 15, 6, 34)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils Grade 1-4 (n=8, 5, 15, 6, 34)
Title
Measurements
OG0002
OG0010
OG0020
OG003
Neutrophils Grade 3-4 (n=8, 5, 15, 6, 34)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets Grade 1-4 (n=8, 5, 15, 6, 34)
Title
Measurements
OG0000
OG0010
OG0021
OG003
Platelets Grade 3-4 (n=8, 5, 15, 6, 34)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin Grade 1-4 (n=8, 5, 15, 6, 34)
Title
Measurements
OG0007
OG0014
OG00212
OG003
Hemoglobin Grade 3-4 (n=8, 5, 15, 6, 34)
Title
Measurements
OG0000
OG0010
OG0021
OG003
Lymphocytes Grade 1-4 (n=8, 5, 15, 6, 34)
Title
Measurements
OG0007
OG0013
OG00212
OG003
Lymphocytes Grade 3-4 (n=8, 5, 15, 6, 34)
Title
Measurements
OG0000
OG0010
OG0022
OG003
OG001
Ipilimumab Monotherapy 5 mg/kg
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.
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
OG004
Ipilimumab 10 mg/kg + XRT Combination
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.
Units
Counts
Participants
OG0008
OG0015
OG00215
OG0036
OG00434
Title
Denominators
Categories
ALT Grade 1-4 (n=8,5,15,6,34)
Title
Measurements
OG0000
OG0012
OG0027
OG0032
OG00410
ALT Grade 3-4 (n=8,5,15,6,34)
Title
Measurements
OG0000
OG0011
OG0022
OG003
AST Grade 1-4 (n=8,5,15,6,34)
Title
Measurements
OG0000
OG0012
OG0026
OG003
AST Grade 3-4 (n=8,5,15,6,34)
Title
Measurements
OG0000
OG0011
OG0022
OG003
Bilirubin Grade 1-4 (n=8,5,15,6,34)
Title
Measurements
OG0000
OG0010
OG0022
OG003
Bilirubin Grade 3-4 (n=8,5,15,6,34)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Phosphatase Grade 1-4 (n=8,5,15,6,34)
Title
Measurements
OG0003
OG0014
OG0027
OG003
Phosphatase Grade 3-4 (n=8,5,15,6,34)
Title
Measurements
OG0000
OG0010
OG0021
OG003
Amylase Grade 1-4 (n=8,5,15,6,34)
Title
Measurements
OG0002
OG0013
OG0024
OG003
Amylase Grade 3-4 (n=8,5,15,6,34)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine Grade 1-4 (n=8,5,15,6,34)
Title
Measurements
OG0000
OG0010
OG0024
OG003
Creatinine Grade 3-4 (n=8,5,15,6,34)
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
OG004
Ipilimumab 10 mg/kg + XRT Combination
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.
Units
Counts
Participants
OG0008
OG0016
OG00215
OG0037
OG00431
Title
Denominators
Categories
ECG Abnormalities at Baseline (n=8, 6, 15, 7, 31)
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0040
ECG Abnormalities During Treatment (n=4,3,11,4,20)
Title
Measurements
OG0000
OG0010
OG0022
OG003
OG002
Ipilimumab Monotherapy 10 mg/kg
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.
OG003
Ipilimumab 3 mg/kg + XRT Combination Therapy
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.
OG004
Ipilimumab 10 mg/kg + XRT Combination
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.