A Companion Study for Patients Enrolled in Prior/Parent I... | NCT00162123 | Trialant
NCT00162123
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Jul 27, 2016Estimated
Enrollment
248Actual
Phase
Phase 2
Conditions
Melanoma
Interventions
Ipilimumab
Countries
United States
Argentina
Austria
Belgium
Brazil
Canada
Czechia
Denmark
France
Germany
Israel
Italy
Norway
Poland
Russia
South Africa
Spain
Ukraine
Protocol Section
Identification Module
NCT ID
NCT00162123
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA184-025
Secondary IDs
Not provided
Brief Title
A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
Official Title
A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Jun 2016
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
May 2006
Primary Completion Date
Sep 2012Actual
Completion Date
Apr 2014Actual
First Submitted Date
Sep 9, 2005
First Submission Date that Met QC Criteria
Sep 9, 2005
First Posted Date
Sep 13, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 31, 2013
Results First Submitted that Met QC Criteria
Mar 19, 2014
Results First Posted Date
Apr 15, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 29, 2011
Certification/Extension First Submitted that Passed QC Review
Aug 30, 2011
Certification/Extension First Posted Date
Sep 2, 2011Estimated
Last Update Submitted Date
Jun 28, 2016
Last Update Posted Date
Jul 27, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.
Detailed Description
Not provided
Conditions Module
Conditions
Melanoma
Keywords
ipilimumab
previously treated
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
248Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
First reinduction: Ipilimumab, 0.3 to 10 mg/kg
Experimental
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Drug: Ipilimumab
First reinduction: Ipilimumab, 3 to 10 mg/kg
Experimental
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Drug: Ipilimumab
First reinduction: Ipilimumab, 10 to 10 mg/kg
Experimental
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Drug: Ipilimumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ipilimumab
Drug
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Extended maintenance: Ipilimumab, 0.3 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is 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. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival (OS)
OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.
From first dose of study drug in parent study to death or date of last censoring.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria
Diagnosis of advanced melanoma
Prior treatment in a prespecified prior/parent ipilimumab study
Had experienced documented progressive disease after expanded clinical benefit
Extended Maintenance
Received ipilimumab at any dose in a parent study
Achieved expanded clinical benefit at the time of entry to current study
Follow-up:
Received ipilimumab at any dose in a closing parent study
Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up
Key Exclusion Criteria
Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab
Lebbe C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day SJ, Konto C, Cykowski L, McHenry MB, Wolchok JD. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies. Ann Oncol. 2014 Nov;25(11):2277-2284. doi: 10.1093/annonc/mdu441. Epub 2014 Sep 10.
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
Of 248 enrolled, 6 failed screening; 28 from study CA184-004 (NCT00261365), 42 from CA184-007 (NCT00135408), 67 from CA184-008 (NCT00289627), and 103 from CA184-022 (NCT00289640) entered CA184-025 (NCT00162123). Of enrollees, 2 from study MDX010-08 (NCT00050102) and 6 from MDX010-15 (NCT00729950) entered maintenance as Tumor Assessment Only.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
First Reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
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
Australia
Chile
Finland
Hungary
Mexico
Peru
Sweden
United Kingdom
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
Parallel 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
Extended maintenance: Ipilimumab, 0.3 mg/kg
Experimental
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Drug: Ipilimumab
Extended maintenance: Ipilimumab, 3 mg/kg
Experimental
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Drug: Ipilimumab
Extended maintenance: Ipilimumab, 10 mg
Experimental
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Drug: Ipilimumab
Follow-up
No Intervention
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Extended maintenance: Ipilimumab, 10 mg
Extended maintenance: Ipilimumab, 3 mg/kg
First reinduction: Ipilimumab, 0.3 to 10 mg/kg
First reinduction: Ipilimumab, 10 to 10 mg/kg
First reinduction: Ipilimumab, 3 to 10 mg/kg
BMS-734016
MDX-010
Percentage of Participants Surviving at 1, 1.5, and 2 Years
Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.
From first dose of study drug in parent study to up to 2 years after reinduction
Number of Participants With On-study Immune-related Adverse Events (irAEs)
irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.
From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date
Progression-free Survival (PFS)
PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.
From day of first reinduction in current study to date of progression or death, whichever occurred first.
Laverne
California
91750
United States
The Angeles Clinic & Research Inst.
Los Angeles
California
90025
United States
Usc/Norris Comprehensive Cancer Center
Los Angeles
California
90033
United States
San Francisco Oncology Associates
San Francisco
California
94115
United States
Local Institution
To Come
Connecticut
United States
Baptist Cancer Institute
Jacksonville
Florida
32207
United States
University Of Chicago
Chicago
Illinois
60637
United States
Indiana Oncology Hematology Consultants
Indianapolis
Indiana
46202
United States
St Joseph Oncology Inc
Saint Joseph
Missouri
64507
United States
Washington University School Of Medicine
St Louis
Missouri
63110
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Carolinas Medical Center
Charlotte
North Carolina
28203
United States
The Christ Hospital Cancer Center Research
Cincinnati
Ohio
45219
United States
Providence Portland Medical Center
Portland
Oregon
97213
United States
Cancer Centers Of The Carolinas
Greenville
South Carolina
29615
United States
Center For Oncology Research & Treatment, P.A.
Dallas
Texas
75230
United States
Joe Arrington Cancer Research And Treatment Center
Lubbock
Texas
79410
United States
University Of Washington Medical Center
Seattle
Washington
98109
United States
Local Institution
Buenos Aires
Buenos Aires
CP1280AEB
Argentina
Local Institution
Vienna
1090
Austria
Local Institution
Wels
A-4600
Austria
Local Institution
Brussels
1070
Belgium
Local Institution
Brussels
1090
Belgium
Local Institution
Brussels
1200
Belgium
Local Institution
Porto Alegre
Rio Grande do Sul
90050
Brazil
Local Institution
Porto Alegre
Rio Grande do Sul
90610
Brazil
Local Institution
Jaú
São Paulo
17210
Brazil
Local Institution
Calgary
Alberta
T2N 4N2
Canada
Local Institution
Edmonton
Alberta
T6G 1Z2
Canada
Local Institution
Moncton
New Brunswick
E1C 6Z8
Canada
Local Institution
Olomouc
775 20
Czechia
Local Institution
Aarhus C
8000
Denmark
Local Institution
Brest
29200
France
Local Institution
Lyon
69373
France
Local Institution
Paris
75010
France
Local Institution
Vandœuvre-lès-Nancy
54511
France
Local Institution
Berlin
D-12200
Germany
Local Institution
Heidelberg
69120
Germany
Local Institution
Kiel
D-24105
Germany
Local Institution
Jerusalem
91120
Israel
Local Institution
Tel Aviv
64239
Israel
Local Institution
Genova
16132
Italy
Local Institution
Meldola (Fc)
47014
Italy
Local Institution
Rimini
47900
Italy
Local Institution
Siena
53100
Italy
Local Institution
Oslo
0310
Norway
Local Institution
Lodz
90553
Poland
Local Institution
Poznan
61-866
Poland
Local Institution
Wroclaw
51-124
Poland
Local Institution
Saint Petersburg
191104
Russia
Local Institution
Stavropol
355047
Russia
Local Institution
Voronezh
394000
Russia
Local Institution
Johannesburg
Gauteng
2199
South Africa
Local Institution
Cape Town
Western Cape
7570
South Africa
Local Institution
Málaga
29010
Spain
Local Institution
Valencia
46009
Spain
Local Institution
Dnipro
49044
Ukraine
FG001
First Reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
FG002
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
FG003
First Reinduction: Ipilimumab, Other Dosage
Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
FG004
Extended Maintenance Only: Ipilimumab, 10 mg/kg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
FG005
Extended Maintenance Only: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
FG006
Extended Maintenance Only: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
FG007
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
FG00053 subjectsEnrolled
FG00134 subjectsEnrolled
FG00224 subjectsEnrolled
FG00311 subjectsEnrolled
FG00445 subjectsEnrolled
FG00513 subjectsEnrolled
FG0064 subjectsEnrolled
FG00758 subjectsEnrolled
Received Treatment
FG00053 subjects
FG00134 subjects
FG00224 subjects
FG00311 subjects
FG00433 subjects
FG00512 subjects
FG0064 subjects
FG0070 subjects
COMPLETED
FG0009 subjectsStill on treatment
FG0015 subjectsStill on treatment
FG0023 subjectsStill on treatment
FG0033 subjectsStill on treatment
FG00414 subjectsStill on treatment
FG0054 subjectsStill on treatment
FG0060 subjectsStill on treatment
FG0070 subjectsStill on treatment
NOT COMPLETED
FG00044 subjects
FG00129 subjects
FG00221 subjects
FG0038 subjects
FG00431 subjects
FG0059 subjects
FG0064 subjects
FG00758 subjects
Type
Comment
Reasons
Disease progression
FG00027 subjects
FG00119 subjects
FG00210 subjects
FG0034 subjects
FG0048 subjects
FG0053 subjects
FG0061 subjects
FG0070 subjects
Study drug toxicity
FG0006 subjects
FG0011 subjects
FG0025 subjects
FG0030 subjects
FG004
Death
FG0003 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Deterioration without progression
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
FG004
Adverse Event
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Not specified (before treatment)
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not specified (after start of treatment)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Tumor assessment only (not treated)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Follow-up only (not treated or assessed)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All patients who were enrolled and passed screening in the current study
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
First Reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
BG001
First Reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
BG002
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
BG003
First Reinduction: Ipilimumab, Other Dosage
Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
BG004
Extended Maintenance: Ipilimumab, 10 mg/kg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
BG005
Extended Maintenance: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
BG006
Extended Maintenance: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
BG007
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00053
BG00134
BG00224
BG00311
BG00445
BG00513
BG0064
BG00758
BG008242
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
BG00055.4± 11.7
BG00158.8± 9.9
BG00256.0± 15.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00021
BG00111
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0010
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG performance status assesses a patient's physical ability against a 6-point scale: 0=fully active, able to carry on all predisease activities without restriction; 1=restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Score ranges from 0=best status to 5=worst status.
Number
Units on a scale
Title
Denominators
Categories
0
Title
Measurements
BG00037
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 On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is 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. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study
Posted
Number
Participants
Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.
ID
Title
Description
OG000
First Reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
OG001
First Reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
OG002
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Units
Counts
Participants
OG00053
OG00134
OG00224
Title
Denominators
Categories
AEs: Any Grade
Title
Measurements
OG00051
OG00133
OG00224
AEs: Grade 3 or 4
Secondary
Overall Survival (OS)
OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.
All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study
Posted
Median
95% Confidence Interval
Months
From first dose of study drug in parent study to death or date of last censoring.
ID
Title
Description
OG000
First Reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
OG001
First Reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Secondary
Percentage of Participants Surviving at 1, 1.5, and 2 Years
Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.
All participants who received study drug as reinduction or extended maintenance from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study and those patients who were followed-up.
Posted
Number
Percentage of participants
From first dose of study drug in parent study to up to 2 years after reinduction
ID
Title
Description
OG000
First Reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
OG001
First Reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Secondary
Number of Participants With On-study Immune-related Adverse Events (irAEs)
irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.
All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study 10 mg/kg current study
Posted
Number
Participants
From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date
ID
Title
Description
OG000
First Reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
OG001
First Reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Secondary
Progression-free Survival (PFS)
PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.
All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study
Posted
Median
95% Confidence Interval
Months
From day of first reinduction in current study to date of progression or death, whichever occurred first.
ID
Title
Description
OG000
First Reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
OG001
First Reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Time Frame
From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Description
Study initiated: May 2006; Study Completion: April 2014
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
First Reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
23
53
46
53
EG001
First Reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
19
34
32
34
EG002
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
14
24
21
24
EG003
First Reinduction: Ipilimumab, Other Dosage
Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
7
11
9
11
EG004
Extended Maintenance Only: Ipilimumab, 10 mg/kg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
12
33
28
33
EG005
Extended Maintenance Only: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
3
12
11
12
EG006
Extended Maintenance Only: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
2
4
3
4
EG007
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
20
58
34
58
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0021 affected24 at risk
EG0030 affected11 at risk
EG0041 affected33 at risk
EG0050 affected12 at risk
EG0060 affected4 at risk
EG0070 affected58 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Age-related macular degeneration
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Amylase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0011 affected34 at risk
EG0022 affected24 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Asthenia
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0012 affected34 at risk
EG0020 affected24 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Blood creatine increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Bronchostenosis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Central nervous system haemorrhage
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Chills
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0011 affected34 at risk
EG0022 affected24 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Death
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0022 affected24 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Diabetic ketoacidotic hyperglycaemic coma
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0013 affected34 at risk
EG0024 affected24 at risk
EG003
Diplegia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Disease progression
General disorders
MedDRA 17.0
Systematic Assessment
EG0004 affected53 at risk
EG0015 affected34 at risk
EG0026 affected24 at risk
EG003
Dry eye
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Endocrine disorder
Endocrine disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Eye pain
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Gastrointestinal hypomotility
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
General physical health deterioration
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Glaucoma
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Lymphocytic hypophysitis
Endocrine disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0022 affected24 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0021 affected24 at risk
EG003
Metastases to spine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0012 affected34 at risk
EG0020 affected24 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0022 affected24 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Sepsis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Tracheal stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Transient global amnesia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0012 affected34 at risk
EG0020 affected24 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Urinary bladder haemorrhage
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
VIIth nerve paralysis
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Volvulus
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0011 affected34 at risk
EG0021 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0007 affected53 at risk
EG0014 affected34 at risk
EG0021 affected24 at risk
EG0030 affected11 at risk
EG0044 affected33 at risk
EG0050 affected12 at risk
EG0060 affected4 at risk
EG0072 affected58 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0006 affected53 at risk
EG0012 affected34 at risk
EG0020 affected24 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0012 affected34 at risk
EG0020 affected24 at risk
EG003
Amylase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0005 affected53 at risk
EG0012 affected34 at risk
EG0022 affected24 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0011 affected34 at risk
EG0021 affected24 at risk
EG003
Apathy
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0005 affected53 at risk
EG0015 affected34 at risk
EG0023 affected24 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0011 affected34 at risk
EG0021 affected24 at risk
EG003
Asthenia
General disorders
MedDRA 17.0
Systematic Assessment
EG0007 affected53 at risk
EG0014 affected34 at risk
EG0021 affected24 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Axillary pain
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0006 affected53 at risk
EG0016 affected34 at risk
EG0021 affected24 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0022 affected24 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Blood urine present
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0021 affected24 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Cataract
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Chills
General disorders
MedDRA 17.0
Systematic Assessment
EG0006 affected53 at risk
EG0012 affected34 at risk
EG0021 affected24 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0010 affected34 at risk
EG0023 affected24 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0006 affected53 at risk
EG0015 affected34 at risk
EG0024 affected24 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0008 affected53 at risk
EG0015 affected34 at risk
EG0023 affected24 at risk
EG003
Cystitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0009 affected53 at risk
EG0015 affected34 at risk
EG0025 affected24 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0011 affected34 at risk
EG0023 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG00017 affected53 at risk
EG0018 affected34 at risk
EG0029 affected24 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0011 affected34 at risk
EG0021 affected24 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0022 affected24 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0010 affected34 at risk
EG0023 affected24 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0004 affected53 at risk
EG0017 affected34 at risk
EG0023 affected24 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0012 affected34 at risk
EG0020 affected24 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Erythema of eyelid
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0021 affected24 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Systematic Assessment
EG00020 affected53 at risk
EG00111 affected34 at risk
EG00210 affected24 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Flushing
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0013 affected34 at risk
EG0022 affected24 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0006 affected53 at risk
EG0017 affected34 at risk
EG0021 affected24 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0022 affected24 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0022 affected24 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0004 affected53 at risk
EG0011 affected34 at risk
EG0022 affected24 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0012 affected34 at risk
EG0020 affected24 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0004 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0012 affected34 at risk
EG0021 affected24 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0012 affected34 at risk
EG0020 affected24 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Influenza like illness
General disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0013 affected34 at risk
EG0023 affected24 at risk
EG003
Iritis
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Local swelling
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Lymphocytic hypophysitis
Endocrine disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Metastatic pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Migraine
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0022 affected24 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0013 affected34 at risk
EG0021 affected24 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0010 affected34 at risk
EG0022 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG00015 affected53 at risk
EG0014 affected34 at risk
EG0027 affected24 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0012 affected34 at risk
EG0021 affected24 at risk
EG003
Oedema peripheral
General disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0011 affected34 at risk
EG0020 affected24 at risk
EG003
Pain
General disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0010 affected34 at risk
EG0023 affected24 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0013 affected34 at risk
EG0021 affected24 at risk
EG003
Photophobia
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG00013 affected53 at risk
EG00112 affected34 at risk
EG0026 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA 17.0
Systematic Assessment
EG0005 affected53 at risk
EG0017 affected34 at risk
EG0024 affected24 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG00010 affected53 at risk
EG00110 affected34 at risk
EG0024 affected24 at risk
EG003
Retinopathy
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected34 at risk
EG0022 affected24 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected34 at risk
EG0021 affected24 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0003 affected53 at risk
EG0013 affected34 at risk
EG0020 affected24 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0012 affected34 at risk
EG0021 affected24 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Vision blurred
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0021 affected24 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected53 at risk
EG0012 affected34 at risk
EG0021 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0009 affected53 at risk
EG0012 affected34 at risk
EG0022 affected24 at risk
EG003
Weight decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0005 affected53 at risk
EG0013 affected34 at risk
EG0024 affected24 at risk
EG003
Xerosis
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected34 at risk
EG0020 affected24 at risk
EG003
Significant heterogeneity existed between patients, who rolled over from 6 studies assessing ipilimumab in different doses and combinations. Since not all eligible patients from parent studies were enrolled, some selection bias existed.
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
D008545
Melanoma
Ancestor Terms
ID
Term
D018358
Neuroendocrine Tumors
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D009380
Neoplasms, Nerve Tissue
D018326
Nevi and Melanomas
D012878
Skin Neoplasms
D009371
Neoplasms by Site
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
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
4 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
12 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
3 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG00757 subjects
57.8
± 13.7
BG00460.5± 12.42
BG00559.0± 16.65
BG00665.5± 4.80
BG00756.3± 12.96
BG00857.7± 12.55
4
BG0031
BG00420
BG0055
BG0061
BG00722
BG00885
Male
BG00032
BG00123
BG00220
BG00310
BG00425
BG0058
BG0063
BG00736
BG008157
0
BG0031
BG0040
BG0050
BG0060
BG0071
BG0082
Black or African American
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
White
Title
Measurements
BG00051
BG00134
BG00224
BG00310
BG00445
BG00513
BG0064
BG00755
BG008236
More than one race
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
American Indian/Alaska native
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0081
Other: Brazilian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0081
22
BG00210
BG0039
BG00440
BG00512
BG0063
BG00729
BG008162
1
Title
Measurements
BG00016
BG00111
BG00213
BG0032
BG0045
BG0051
BG0061
BG00710
BG00859
2
Title
Measurements
BG0000
BG0011
BG0021
BG0030
BG0040
BG0050
BG0060
BG0071
BG0083
3
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0081
Not reported
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG00717
BG00817
Title
Measurements
OG00018
OG00110
OG00210
AEs: Grade 5 (Fatal)
Title
Measurements
OG0004
OG0017
OG0028
AEs leading to discontinuation: Any grade
Title
Measurements
OG00013
OG0016
OG0028
AEs leading to discontinuation: Grade 3 or 4
Title
Measurements
OG0009
OG0013
OG0026
AEs leading to discontinuation: Grade 5 (Fatal)
Title
Measurements
OG0001
OG0012
OG0021
SAEs: Any grade
Title
Measurements
OG00023
OG00119
OG00214
SAEs: Grade 3 or 4
Title
Measurements
OG00013
OG0018
OG0025
SAEs: Grade 5 (Fatal)
Title
Measurements
OG0004
OG0017
OG0028
Drug-related AEs: Any grade
Title
Measurements
OG00042
OG00128
OG00221
Drug-related AEs: Grade 3 or 4
Title
Measurements
OG0009
OG0013
OG0029
Drug-related AEs: Grade 5 (Fatal)
Title
Measurements
OG0000
OG0010
OG0020
irAEs: Any grade
Title
Measurements
OG00030
OG00123
OG00218
irAEs: Grade 3 or 4
Title
Measurements
OG0007
OG0012
OG0026
irAEs: Grade 5 (Fatal)
Title
Measurements
OG0000
OG0010
OG0020
Deaths
Title
Measurements
OG00036
OG00127
OG00219
OG002
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Units
Counts
Participants
OG00053
OG00134
OG00224
Title
Denominators
Categories
Title
Measurements
OG00030.8(24.2 to 41.1)
OG00118.7(9.7 to 30.4)
OG00215.2(10.7 to 21.4)
OG002
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 0.3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
OG003
Extended Maintenance: Ipilimumab, 10 mg/kg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
OG004
Extended Maintenance: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
OG005
Extended Maintenance: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
OG006
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Units
Counts
Participants
OG00053
OG00134
OG00224
OG00333
OG00412
OG0054
OG00658
Title
Denominators
Categories
1 year
Title
Measurements
OG00080.9
OG00155.9
OG00265.6
OG003100
OG004100
OG00575.0
OG00687.8
1.5 years
Title
Measurements
OG00071.3
OG00150.0
OG00235.0
OG003
2 years
Title
Measurements
OG00063.6
OG00138.2
OG00230.6
OG003
OG002
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Units
Counts
Participants
OG00053
OG00134
OG00224
Title
Denominators
Categories
Any irAE: Any grade
Title
Measurements
OG00030
OG00123
OG00218
Any irAE: Grade 3 or 4
Title
Measurements
OG0007
OG0012
OG0026
Any irAE: Grade 5 (Fatal)
Title
Measurements
OG0000
OG0010
OG0020
Gastrointestinal irAE: Any grade
Title
Measurements
OG00011
OG0017
OG00214
Gastrointestinal irAE: Grade 3 or 4
Title
Measurements
OG0002
OG0011
OG0023
Hepatic irAE: Any grade
Title
Measurements
OG0003
OG0010
OG0021
Hepatic irAE: Grade 3 or 4
Title
Measurements
OG0002
OG0010
OG0021
Endocrine irAE: Any grade
Title
Measurements
OG0003
OG0012
OG0021
Endocrine irAE: Grade 3 or 4
Title
Measurements
OG0001
OG0010
OG0021
Skin irAE: Any grade
Title
Measurements
OG00018
OG00118
OG00210
Skin irAE: Grade 3 or 4
Title
Measurements
OG0002
OG0011
OG0021
Neurologic irAE: Any grade
Title
Measurements
OG0001
OG0010
OG0020
Neurologic irAE: Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
Other irAE: Any grade
Title
Measurements
OG0002
OG0013
OG0021
Other irAE: Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG002
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.