Phase II Study for Previously Untreated Subjects With Non... | NCT00527735 | Trialant
NCT00527735
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Jul 18, 2018Actual
Enrollment
334Actual
Phase
Phase 2
Conditions
Lung Cancer
Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Interventions
Ipilimumab
Placebo
Paclitaxel
Carboplatin
Countries
United States
France
Germany
India
Italy
Poland
Russia
Ukraine
Protocol Section
Identification Module
NCT ID
NCT00527735
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA184-041
Secondary IDs
Not provided
Brief Title
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
Official Title
A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Jun 2018
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
Feb 2008
Primary Completion Date
Oct 2009Actual
Completion Date
Dec 2011Actual
First Submitted Date
Sep 7, 2007
First Submission Date that Met QC Criteria
Sep 10, 2007
First Posted Date
Sep 11, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 23, 2012
Results First Submitted that Met QC Criteria
Jun 11, 2012
Results First Posted Date
Jul 16, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 29, 2011
Certification/Extension First Submitted that Passed QC Review
Jan 29, 2011
Certification/Extension First Posted Date
May 18, 2011Estimated
Last Update Submitted Date
Jun 18, 2018
Last Update Posted Date
Jul 18, 2018Actual
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 the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.
Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)
irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.
Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)
Secondary Outcomes
Measure
Description
Time Frame
Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria
By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer [SCLC])
Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria
Eastern Cooperative Oncology Group performance status of ≤1 at study entry
Accessible for treatment and follow-up
Exclusion Criteria:
Brain metastases
Malignant pleural effusion
Autoimmune disease
Motor neuropathy of autoimmune origin
SCLC-related paraneoplastic syndromes
Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)
Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.
Grade 2 peripheral neuropathy (motor or sensory)
Known HIV or hepatitis B or C infection
Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
Inadequate hematologic function defined by an absolute neutrophil count <1,500/mm^3, a platelet count <100,000/mm^3, or hemoglobin level <9 g/dL.
Inadequate hepatic function defined by a total bilirubin level >2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present.
Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN
Inadequate creatinine clearance defined as less than 50 mL/min.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Birmingham Hematology & Oncology Assoc. Llc
Birmingham
Alabama
35235
United States
Mayo Clinic
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Of 334 participants enrolled in this study, 331 received treatment. One patient with nonsmall-cell lung cancer, randomized to the sequential arm but mistakenly treated with concurrent therapy, is included in the sequential arm for efficacy results and in the concurrent arm for safety results.
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease (PD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.
Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)
Overall Survival in Participants With NSCLC
Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.
Randomization date to date of death (of censored, maximum reached: 26.5 months)
Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC
mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of >=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.
Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)
irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.
Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC
irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.
Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)
Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC
irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.
Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade
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. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade
CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:\
At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
irPFS in Participants With SCLC Per irRC
IRC performed TA.
Randomization date to date of irPD or death (maximum reached: 22 months)
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade
ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.
At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings
Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.
At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade
ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Creatine (mg/dL) Grade 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.
At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline
An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade
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. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade
CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:\
At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.
At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade
ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Gr 2 >1.5 to 2.0*ULN, Gr 3 >2.0 to 5.0*ULN, Gr 4 >5.0*ULN. Creatine (mg/dL) Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.
At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria
By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.
Randomization date to date of progression or death (of censored, maximum reached: 22 months)
Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings
Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.
Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment
Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline
An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Overall Survival in Participants With SCLC
Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.
Randomization date to date of death (of censored, maximum reached: 22 months)
Scottsdale
Arizona
85259
United States
Acrc/Arizona Clinical Research Center, Inc.
Tucson
Arizona
85715
United States
Compassionate Cancer Care Medical Group
Corona
California
92879
United States
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley
California
92708
United States
The Angeles Clinic & Research Institute, Inc
Los Angeles
California
90025
United States
Oncology Care Medical Associates
Montebello
California
90640
United States
Compassionate Cancer Care Medical Group
Riverside
California
92501
United States
Sharp Clinical Oncology Research
San Diego
California
92123
United States
M D Anderson Cancer Center- Orlando
Orlando
Florida
32806
United States
Georgia Cancer Specialists
Atlanta
Georgia
30341
United States
University Of Chicago Medical Center
Chicago
Illinois
60637
United States
Local Institution
Park Ridge
Illinois
60068
United States
Kentucky Cancer Clinic
Hazard
Kentucky
41701
United States
The John R. Marsh Cancer Center
Hagerstown
Maryland
21740
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
The Cancer Center
Minneapolis
Minnesota
55455
United States
Nevada Cancer Institute
Las Vegas
Nevada
89135
United States
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
Local Institution
New York
New York
10017
United States
Cmc-Northeast/ Northeast Oncology Associates
Concord
North Carolina
28025
United States
Gabrail Cancer Center
Canton
Ohio
44718
United States
Hematology Oncology Consultants, Inc
Columbus
Ohio
43235
United States
St. Mary Medical Center
Langhorne
Pennsylvania
19047
United States
Guthrie Clinical Research
Sayre
Pennsylvania
18840
United States
Santee Hematology/Oncology
Sumter
South Carolina
29150
United States
Southwest Cancer Treatment And Research Center
Lubbock
Texas
79415
United States
Local Institution
Belfort
90016
France
Local Institution
Caen
14076
France
Local Institution
Marseille
13274
France
Local Institution
Rennes
35033
France
Local Institution
Bochum
44791
Germany
Local Institution
Cologne
51109
Germany
Local Institution
Coswig
01640
Germany
Local Institution
Ebensfeld
96250
Germany
Local Institution
Großhansdorf
22927
Germany
Local Institution
Halle
06120
Germany
Local Institution
Hamburg
21075
Germany
Local Institution
Leipzig
04103
Germany
Local Institution
Mainz
55131
Germany
Local Institution
München
81675
Germany
Local Institution
Hyderabad
Andhra Pradesh
500082
India
Local Institution
Navrangpura, Ahmedabad
Gujarat
380009
India
Local Institution
Manipal
Karnataka
576104
India
Local Institution
Trivandrum
Kerala
695011
India
Local Institution
Vellore
632004
India
Local Institution
Genova
16132
Italy
Local Institution
Siena
53100
Italy
Local Institution
Torino
10143
Italy
Local Institution
Gdansk
80-952
Poland
Local Institution
Krakow
31-826
Poland
Local Institution
Olsztyn
10-513
Poland
Local Institution
Szczecin
70-891
Poland
Local Institution
Arkhangelsk
163045
Russia
Local Institution
Chelyabinsk
454087
Russia
Local Institution
Ivanovo
153013
Russia
Local Institution
Moscow
105077
Russia
Local Institution
Moscow
115478
Russia
Local Institution
Moscow
125284
Russia
Local Institution
Pyatigorsk
357502
Russia
Local Institution
Saint Petersburg
190005
Russia
Local Institution
Saint Petersburg
194044
Russia
Local Institution
Saint Petersburg
194291
Russia
Local Institution
Saint Petersburg
197022
Russia
Local Institution
Saint Petersburg
198255
Russia
Local Institution
Sochi
354057
Russia
Local Institution
Dnipropetrovsk
49102
Ukraine
Local Institution
Donetsk
83092
Ukraine
Local Institution
Kharkiv
46023
Ukraine
Local Institution
Lviv
79031
Ukraine
Local Institution
Ternopil
46023
Ukraine
Local Institution
Uzhhorod
88014
Ukraine
FG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
FG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
BG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who experienced clinical benefit on treatment phase without intolerable toxicity could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000113
BG001110
BG002111
BG003334
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Age of participants who received treatment.
Number
Participants
Title
Denominators
Categories
Younger than 65 years
Title
Measurements
BG00079
BG00173
BG00276
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00027
BG00129
BG002
Age Customized, by Disease Type
NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer
Number
Participants
Title
Denominators
Categories
Younger than 65 years (NSCLC patients)
Title
Measurements
BG00044
BG00144
BG002
Gender, by Disease Type
NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer
Number
Participants
Title
Denominators
Categories
Female (NSCLC patients)
Title
Measurements
BG00017
BG00119
BG002
Disease Stage at Study Entry
NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer. Staging of NSCLC is based on the findings of several clinical tests, including magnetic resonance imaging scans and fine needle biopsy. Stages range from 1 (best prognosis) to IV (worst prognosis). Stage I cancer is confined to the lung. Stages II and III cancers are locally advanced. Stage IV cancer has spread outside the lung to other organs. SCLC is staged using a 2-tiered system: Limited stage SCLC is confined to its area of origin in the lung and lumph nodes. Extensive-stage SCLC has spread beyond the lung to other organs.
Number
Participants
Title
Denominators
Categories
Stage IIIB (NSCLC patients)
Title
Measurements
BG00011
BG001
Cell Type
NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer
Number
Participants
Title
Denominators
Categories
Adenocarcinoma (NSCLC patients)
Title
Measurements
BG00035
BG00130
BG002
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
Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)
irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.
All participants with NSCLC who were randomized to a treatment group.
Posted
Median
95% Confidence Interval
Months
Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG00070
OG00168
OG00266
Title
Denominators
Categories
Title
Measurements
OG0005.52(4.17 to 6.74)
OG0015.68(4.76 to 7.79)
OG0024.63(4.14 to 5.52)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
1-sided log rank
0.1302
Hazard Ratio (HR)
0.806
2-Sided
95
0.553
1.174
Superiority or Other
OG001
OG002
1-sided log rank
0.0473
Secondary
Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria
By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.
All NSCLC participants who were randomized to a treatment group.
Posted
Mean
95% Confidence Interval
Months
Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Overall Survival in Participants With NSCLC
Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.
All NSCLC participants who were randomized to a treatment group.
Posted
Median
95% Confidence Interval
Months
Randomization date to date of death (of censored, maximum reached: 26.5 months)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC
mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of >=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.
All participants who were randomized to a treatment group.
Posted
Number
95% Confidence Interval
Percentage of participants
Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)
irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.
All participants who were randomized to a treatment group.
Posted
Number
95% Confidence Interval
Percentage of participants
Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC
irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.
All participants who were randomized to a treatment group.
Posted
Number
95% Confidence Interval
Percent of participants
Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC
irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.
All participants who were randomized to a treatment group.
Posted
Median
95% Confidence Interval
Months
Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade
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. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
All participants with NSCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.
Posted
Number
Participants
Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade
CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:\
All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study hematology test result available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.
Posted
Number
Percentage of participants
At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
irPFS in Participants With SCLC Per irRC
IRC performed TA.
All participants with SCLC who were randomized to a treatment group.
Posted
Mean
95% Confidence Interval
Months
Randomization date to date of irPD or death (maximum reached: 22 months)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade
ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.
All participants with NSCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study liver function measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.
Posted
Number
Participants
At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings
Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.
All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.
Posted
Number
Participants
At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade
ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Creatine (mg/dL) Grade 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.
All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study pancreatic enzyme laboratory test measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.
Posted
Number
Percentage of participants
At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline
An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
Participants with at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.
Posted
Number
Participants
Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
Secondary
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade
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. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
All participants with SCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin.
Posted
Number
Participants
Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade
CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:\
All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study hematology test result available.
Posted
Number
Participants
At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.
All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study liver function test result available.
Posted
Number
Participants
At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade
ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Gr 2 >1.5 to 2.0*ULN, Gr 3 >2.0 to 5.0*ULN, Gr 4 >5.0*ULN. Creatine (mg/dL) Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.
All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study pancreatic enzyme or other laboratory test measurement available.
Posted
Number
Percentage of participants
At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
Secondary
Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria
By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.
All participants with SCLC who were randomized to a treatment group.
Posted
Mean
95% Confidence Interval
Months
Randomization date to date of progression or death (of censored, maximum reached: 22 months)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Secondary
Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings
Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.
All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.
Posted
Number
Participants
Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline
An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
Participants with SCLC who had at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.
Posted
Number
Participants
Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
Secondary
Overall Survival in Participants With SCLC
Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.
All participants with SCLC who were randomized to a treatment group.
Posted
Median
95% Confidence Interval
Months
Randomization date to date of death (of censored, maximum reached: 22 months)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
36
67
63
67
EG002
Placebo + Paclitaxel/Carboplatin NSCLC
During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
21
42
39
42
EG005
Placebo + Paclitaxel/Carboplatin SCLC
During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
20
44
41
44
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0014 affected67 at risk
EG0021 affected65 at risk
EG0030 affected42 at risk
EG0042 affected42 at risk
EG0052 affected44 at risk
ARTERIAL THROMBOSIS
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
AUTOIMMUNE HEPATITIS
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
GASTROENTERITIS SHIGELLA
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
HYPOPITUITARISM
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
MALIGNANT PLEURAL EFFUSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
METABOLIC ACIDOSIS
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
METASTATIC NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0023 affected65 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0022 affected65 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0021 affected65 at risk
EG003
PERICARDIAL EFFUSION
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
SIALOADENITIS
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0011 affected67 at risk
EG0021 affected65 at risk
EG003
TUMOUR PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
ACUTE MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected71 at risk
EG0012 affected67 at risk
EG0024 affected65 at risk
EG003
ERYSIPELAS
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
ERYTHEMA MULTIFORME
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected71 at risk
EG0011 affected67 at risk
EG0022 affected65 at risk
EG003
HEPATITIS
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0011 affected67 at risk
EG0022 affected65 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
LUNG NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
MALIGNANT NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0002 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0003 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0012 affected67 at risk
EG0021 affected65 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
BRONCHITIS CHRONIC
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
CACHEXIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
CEREBRAL HAEMORRHAGE
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0012 affected67 at risk
EG0020 affected65 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
DYSARTHRIA
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0012 affected67 at risk
EG0020 affected65 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
GENERAL PHYSICAL HEALTH DETERIORATION
General disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0012 affected67 at risk
EG0020 affected65 at risk
EG003
HEPATITIS ACUTE
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
HYDROCEPHALUS
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
HYPOPHYSITIS
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
MULTI-ORGAN FAILURE
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
PERICARDIAL EFFUSION MALIGNANT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
PERIPHERAL ISCHAEMIA
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
PYREXIA
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0013 affected67 at risk
EG0020 affected65 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0011 affected67 at risk
EG0021 affected65 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
TACHYARRHYTHMIA
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
THROMBOPHLEBITIS
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0012 affected67 at risk
EG0022 affected65 at risk
EG003
ASTHENIA
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0011 affected67 at risk
EG0021 affected65 at risk
EG003
ATAXIA
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
EPILEPSY
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
FEBRILE INFECTION
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
GASTROINTESTINAL INFECTION
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
ILEAL PERFORATION
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
LUNG CANCER METASTATIC
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0003 affected71 at risk
EG0011 affected67 at risk
EG0023 affected65 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0003 affected71 at risk
EG0010 affected67 at risk
EG0023 affected65 at risk
EG003
OBSTRUCTIVE AIRWAYS DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
OPTIC ISCHAEMIC NEUROPATHY
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
PSEUDOMONAL SEPSIS
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
RENAL FAILURE ACUTE
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
TOXIC EPIDERMAL NECROLYSIS
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
CERVICAL CORD COMPRESSION
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
CHEST PAIN
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
CLOSTRIDIUM DIFFICILE COLITIS
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
DERMATITIS EXFOLIATIVE
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0011 affected67 at risk
EG0021 affected65 at risk
EG003
MACULAR CYST
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
MALNUTRITION
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0021 affected65 at risk
EG003
NON-SMALL CELL LUNG CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0012 affected67 at risk
EG0021 affected65 at risk
EG003
PAIN
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
PNEUMONIA ASPIRATION
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
SALIVARY GLAND CALCULUS
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0022 affected65 at risk
EG003
UPPER LIMB FRACTURE
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
ANAPHYLACTIC REACTION
Immune system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
ANGINA PECTORIS
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0012 affected67 at risk
EG0020 affected65 at risk
EG003
CONVULSION
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0007 affected71 at risk
EG0015 affected67 at risk
EG0024 affected65 at risk
EG003
DUODENAL ULCER
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
ENTERITIS
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
GASTROINTESTINAL PERFORATION
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
GRAND MAL CONVULSION
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
HEPATIC ENZYME INCREASED
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
MEDIASTINAL DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
MENINGITIS
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
METASTASES TO CENTRAL NERVOUS SYSTEM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
OESOPHAGEAL DISORDER
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
PATHOLOGICAL FRACTURE
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
PERIPHERAL SENSORIMOTOR NEUROPATHY
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
PULMONARY HAEMORRHAGE
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0023 affected65 at risk
EG003
SQUAMOUS CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
VENOUS THROMBOSIS
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
ABDOMINAL HERNIA
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
BASAL GANGLIA HAEMORRHAGE
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
BILIARY COLIC
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
CARDIO-RESPIRATORY ARREST
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0012 affected67 at risk
EG0020 affected65 at risk
EG003
DEATH
General disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected71 at risk
EG0014 affected67 at risk
EG0022 affected65 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0012 affected67 at risk
EG0022 affected65 at risk
EG003
EROSIVE OESOPHAGITIS
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
FATIGUE
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0012 affected67 at risk
EG0021 affected65 at risk
EG003
FEMUR FRACTURE
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
HEPATOTOXICITY
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
LOCALISED OEDEMA
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
LUNG NEOPLASM MALIGNANT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0014 affected67 at risk
EG0025 affected65 at risk
EG003
MONOPLEGIA
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
PERIPHERAL MOTOR NEUROPATHY
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0021 affected65 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
SUDDEN DEATH
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0012 affected67 at risk
EG0020 affected65 at risk
EG003
TRACHEO-OESOPHAGEAL FISTULA
Congenital, familial and genetic disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
ACIDOSIS
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
BILE DUCT STENOSIS
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
DISEASE PROGRESSION
General disorders
MedDRA 13.0
Systematic Assessment
EG0005 affected71 at risk
EG0011 affected67 at risk
EG0024 affected65 at risk
EG003
DROWNING
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
GASTRITIS EROSIVE
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
ICHTHYOSIS
Congenital, familial and genetic disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
LOBAR PNEUMONIA
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
LUNG DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0021 affected65 at risk
EG003
OCCIPITAL NEURALGIA
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
PLEURAL INFECTION BACTERIAL
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0005 affected71 at risk
EG0012 affected67 at risk
EG0022 affected65 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
VENTRICULAR FIBRILLATION
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG00022 affected71 at risk
EG00115 affected67 at risk
EG00219 affected65 at risk
EG00313 affected42 at risk
EG00412 affected42 at risk
EG00510 affected44 at risk
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG00018 affected71 at risk
EG00111 affected67 at risk
EG00210 affected65 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0009 affected71 at risk
EG0017 affected67 at risk
EG0025 affected65 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0005 affected71 at risk
EG0011 affected67 at risk
EG0021 affected65 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG00022 affected71 at risk
EG00127 affected67 at risk
EG00222 affected65 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0007 affected71 at risk
EG0019 affected67 at risk
EG0025 affected65 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0013 affected67 at risk
EG0022 affected65 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0016 affected67 at risk
EG0022 affected65 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG00013 affected71 at risk
EG00110 affected67 at risk
EG00211 affected65 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0015 affected67 at risk
EG0023 affected65 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected71 at risk
EG0012 affected67 at risk
EG0025 affected65 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0011 affected67 at risk
EG0028 affected65 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 13.0
Systematic Assessment
EG00010 affected71 at risk
EG00110 affected67 at risk
EG0025 affected65 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG00013 affected71 at risk
EG00110 affected67 at risk
EG00215 affected65 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0015 affected67 at risk
EG0023 affected65 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0012 affected67 at risk
EG0021 affected65 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA 13.0
Systematic Assessment
EG0003 affected71 at risk
EG0015 affected67 at risk
EG0022 affected65 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0008 affected71 at risk
EG0019 affected67 at risk
EG0028 affected65 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0012 affected67 at risk
EG0021 affected65 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG00014 affected71 at risk
EG0017 affected67 at risk
EG0024 affected65 at risk
EG003
PYREXIA
General disorders
MedDRA 13.0
Systematic Assessment
EG00017 affected71 at risk
EG00111 affected67 at risk
EG0027 affected65 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG00024 affected71 at risk
EG0019 affected67 at risk
EG0026 affected65 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG00019 affected71 at risk
EG00114 affected67 at risk
EG00213 affected65 at risk
EG003
ASTHENIA
General disorders
MedDRA 13.0
Systematic Assessment
EG00014 affected71 at risk
EG00120 affected67 at risk
EG00211 affected65 at risk
EG003
CHILLS
General disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0011 affected67 at risk
EG0026 affected65 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG00016 affected71 at risk
EG00118 affected67 at risk
EG00212 affected65 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0010 affected67 at risk
EG0022 affected65 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG00011 affected71 at risk
EG00115 affected67 at risk
EG00215 affected65 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 13.0
Systematic Assessment
EG0008 affected71 at risk
EG0016 affected67 at risk
EG0026 affected65 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0011 affected67 at risk
EG0028 affected65 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0015 affected67 at risk
EG0023 affected65 at risk
EG003
CHEST PAIN
General disorders
MedDRA 13.0
Systematic Assessment
EG0009 affected71 at risk
EG0018 affected67 at risk
EG00211 affected65 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0015 affected67 at risk
EG0021 affected65 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0006 affected71 at risk
EG0014 affected67 at risk
EG0024 affected65 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0003 affected71 at risk
EG0017 affected67 at risk
EG0027 affected65 at risk
EG003
PAIN
General disorders
MedDRA 13.0
Systematic Assessment
EG0007 affected71 at risk
EG0018 affected67 at risk
EG0027 affected65 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0003 affected71 at risk
EG0010 affected67 at risk
EG0020 affected65 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG00010 affected71 at risk
EG00113 affected67 at risk
EG00212 affected65 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected71 at risk
EG0012 affected67 at risk
EG0027 affected65 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG00021 affected71 at risk
EG00120 affected67 at risk
EG00214 affected65 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0007 affected71 at risk
EG0012 affected67 at risk
EG0023 affected65 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0005 affected71 at risk
EG0011 affected67 at risk
EG0024 affected65 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0005 affected71 at risk
EG0011 affected67 at risk
EG0026 affected65 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0005 affected71 at risk
EG0015 affected67 at risk
EG0026 affected65 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0012 affected67 at risk
EG0022 affected65 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0012 affected67 at risk
EG0022 affected65 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG00021 affected71 at risk
EG00111 affected67 at risk
EG00217 affected65 at risk
EG003
FATIGUE
General disorders
MedDRA 13.0
Systematic Assessment
EG00026 affected71 at risk
EG00124 affected67 at risk
EG00224 affected65 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0004 affected71 at risk
EG0016 affected67 at risk
EG0025 affected65 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0006 affected71 at risk
EG0014 affected67 at risk
EG0027 affected65 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG00012 affected71 at risk
EG00110 affected67 at risk
EG00219 affected65 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected71 at risk
EG0011 affected67 at risk
EG0024 affected65 at risk
EG003
PERIPHERAL MOTOR NEUROPATHY
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0010 affected67 at risk
EG0023 affected65 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0007 affected71 at risk
EG00114 affected67 at risk
EG0029 affected65 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG00027 affected71 at risk
EG00132 affected67 at risk
EG00231 affected65 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG00011 affected71 at risk
EG0016 affected67 at risk
EG0029 affected65 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0003 affected71 at risk
EG0012 affected67 at risk
EG0024 affected65 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0008 affected71 at risk
EG0015 affected67 at risk
EG0025 affected65 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG00011 affected71 at risk
EG0019 affected67 at risk
EG0022 affected65 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0007 affected71 at risk
EG0011 affected67 at risk
EG0021 affected65 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected71 at risk
EG0011 affected67 at risk
EG0020 affected65 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0005 affected71 at risk
EG0012 affected67 at risk
EG0021 affected65 at risk
EG003
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.
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG00070
OG00168
OG00266
Title
Denominators
Categories
Title
Measurements
OG0004.11(2.76 to 5.32)
OG0015.13(4.17 to 5.72)
OG0024.21(2.76 to 5.32)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
One-sided log rank
0.2502
Hazard Ratio (HR)
0.882
2-Sided
95
0.612
1.271
Superiority or Other
OG001
OG002
One-sided log rank
0.0240
Hazard Ratio (HR)
0.691
2-Sided
95
0.478
0.999
Superiority or Other
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG00070
OG00168
OG00266
Title
Denominators
Categories
Title
Measurements
OG0009.69(7.59 to 12.48)
OG00112.22(9.26 to 14.39)
OG0028.28(6.80 to 12.39)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
1-sided log rank
0.4759
Hazard Ratio (HR)
0.988
2-Sided
95
0.669
1.460
Superiority or Other
OG001
OG002
1-sided log rank
0.2340
Hazard Ratio (HR)
0.866
2-Sided
95
0.587
1.278
Superiority or Other
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG000113
OG001110
OG002111
Title
Denominators
Categories
BORR (mWHO criteria) NSCLC cohort (n=70, 68, 66)
Title
Measurements
OG00021.4(12.5 to 32.29)
OG00132.4(21.5 to 44.8)
OG00213.6(6.4 to 24.3)
BORR (mWHO criteria) SCLC cohort (n=43, 42, 45)
Title
Measurements
OG00032.6(19.1 to 48.5)
OG00157.1(41.0 to 72.3)
OG00248.9(33.7 to 64.2)
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG000113
OG001110
OG002111
Title
Denominators
Categories
irBORR ( irRC) NSCLC cohort (n=70, 68, 66)
Title
Measurements
OG00021.4(12.5 to 32.29)
OG00132.4(21.5 to 44.8)
OG00218.2(9.8 to 29.6)
irBORR (irRC) SCLC cohort (n=43, 42, 45)
Title
Measurements
OG00048.8(33.3 to 64.5)
OG00171.4(55.4 to 84.3)
OG00253.3(37.9 to 68.3)
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG000113
OG001110
OG002111
Title
Denominators
Categories
irDCR (irRC) NSCLC cohort (n=70, 68, 66)
Title
Measurements
OG00070.0(57.9 to 80.4)
OG00186.8(76.4 to 93.8)
OG00281.8(70.4 to 90.2)
DCR (mWHO criteria) NSCLC cohort (n=70, 68, 66)
Title
Measurements
OG00057.1(44.7 to 68.9)
OG00177.9(66.2 to 87.1)
OG00272.7(60.4 to 83.0)
rDCR (irRC) SCLC cohort (n=43, 42, 45)
Title
Measurements
OG00081.4(66.6 to 91.6)
OG00192.9(80.5 to 98.5)
OG00295.6(84.9 to 99.5)
DCR (mWHO criteria) SCLC cohort (n=43, 42, 45)
Title
Measurements
OG00069.8(53.9 to 82.8)
OG00181.0(65.9 to 91.4)
OG00293.3(81.7 to 98.6)
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG000113
OG001110
OG002111
Title
Denominators
Categories
irDoR (irRC) NSCLC cohort (n=70, 63, 62)
Title
Measurements
OG0006.70(4.21 to 8.51)
OG0015.55(4.27 to 6.74)
OG0024.01(4.01 to 5.72)
DoR (mWHO criteria) NSCLC cohort (n=70, 63, 62)
Title
Measurements
OG0005.42(4.21 to 7.43)
OG0015.55(4.27 to 6.74)
OG0024.01(3.94 to 5.59)
irDoR (irRC) SCLC cohort (n=43, 42, 45)
Title
Measurements
OG0005.95(4.53 to 10.8)
OG0015.78(4.44 to 6.67)
OG0024.21(3.91 to 6.41)
DoR (mWHO criteria) SCLC cohort (n=43, 42, 45)
Title
Measurements
OG0007.62(4.90 to 11.1)
OG0015.78(3.94 to 6.57)
OG0024.21(3.91 to 5.95)
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG00071
OG00167
OG00265
Title
Denominators
Categories
White blood cell count, Grades 3 and 4
Title
Measurements
OG0007.7
OG0016.2
OG0023.2
Hemoglobin, Any grade
Title
Measurements
OG00090.8
OG00198.5
OG00290.2
Hemoglobin, Grades 3 and 4
Title
Measurements
OG00010.8
OG0016.2
OG0026.3
ANC, Grades 3 and 4
Title
Measurements
OG0007.7
OG0011.5
OG0029.5
Platelets, Grades 3 and 4
Title
Measurements
OG0001.5
OG0013.1
OG0029.5
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG00071
OG00167
OG00265
Title
Denominators
Categories
Vital sign measurements
Title
Measurements
OG0000
OG0010
OG0020
Physical examination findings
Title
Measurements
OG0000
OG0010
OG0020
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG00071
OG00167
OG00265
Title
Denominators
Categories
Lipase, Grades 3 and 4
Title
Measurements
OG0007.7
OG0016.2
OG0023.2
Amylase, Grades 3 and 4
Title
Measurements
OG0001.5
OG0014.6
OG0021.6
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Units
Counts
Participants
OG00061
OG00156
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG001
Ipilimumab + Paclitaxel/Carboplatin (Sequential)
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG00042
OG00142
OG00244
Title
Denominators
Categories
ALT, Grade 1
Title
Measurements
OG00012
OG00112
OG0028
ALT, Grade 2
Title
Measurements
OG0002
OG0013
OG0021
ALT, Grades 3 & 4
Title
Measurements
OG0007
OG0012
OG0020
AST, Grade 1
Title
Measurements
OG00011
OG00113
OG00212
AST, Grade 2
Title
Measurements
OG0004
OG0011
OG0022
AST, Grades 3 & 4
Title
Measurements
OG0005
OG0013
OG0020
Total bilirubin, Grade 1
Title
Measurements
OG0004
OG0015
OG0023
Total bilirubin, Grade 2
Title
Measurements
OG0001
OG0010
OG0020
Total bilirubin, Grades 3 & 4
Title
Measurements
OG0001
OG0010
OG0020
ALK, Grade 1
Title
Measurements
OG00015
OG00114
OG00216
ALK, Grade 2
Title
Measurements
OG0001
OG0013
OG0022
ALK, Grades 3 & 4
Title
Measurements
OG0000
OG0010
OG0020
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG00043
OG00142
OG00245
Title
Denominators
Categories
Title
Measurements
OG0003.89(2.89 to 5.85)
OG0015.22(4.14 to 6.57)
OG0025.19(4.40 to 5.59)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
1-sided Log Rank
0.3846
Hazard Ratio (HR)
0.933
2-Sided
95
0.588
1.481
Superiority or Other
OG001
OG002
1-sided Log Rank
0.3700
Hazard Ratio (HR)
0.927
2-Sided
95
0.591
1.453
Superiority or Other
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Units
Counts
Participants
OG00042
OG00142
OG00244
Title
Denominators
Categories
Vital sign measurements
Title
Measurements
OG0000
OG0010
OG0020
Physical examination findings
Title
Measurements
OG0000
OG0010
OG0020
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Units
Counts
Participants
OG00038
OG00141
Title
Denominators
Categories
Positive at any timepoint (n=42, 42)
Title
Measurements
OG0002
OG0013
Positive postbaseline (n=38, 41)
Title
Measurements
OG0002
OG0010
During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
OG002
Placebo + Paclitaxel/Carboplatin
During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.