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Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

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ClinicalTrials.gov Identifier: NCT00527735
Recruitment Status : Completed
First Posted : September 11, 2007
Results First Posted : July 16, 2012
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Lung Cancer
Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Interventions Drug: Ipilimumab
Drug: Placebo
Drug: Paclitaxel
Drug: Carboplatin
Enrollment 334
Recruitment Details  
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 113 [1] 109 [1] 109 [1]
Completed 5 [2] 2 [2] 2 [2]
Not Completed 108 107 107
Reason Not Completed
Disease progression             47             61             53
Death             23             13             15
Completed treatment in treatment phase             14             13             18
Adverse Event             10             6             7
Not identified             5             5             5
Withdrawal by Subject             5             4             3
No longer met study criteria             2             2             1
Lost to Follow-up             0             0             3
Poor compliance or noncompliance             0             1             1
Completed treatment during maintenance             2             2             1
[1]
Treated
[2]
Still on treatment
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 113 110 111 334
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 110 participants 111 participants 334 participants
Younger than 65 years 79 73 76 228
65 years and older 34 37 35 106
[1]
Measure Description: Age of participants who received treatment.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 110 participants 111 participants 334 participants
Female
27
  23.9%
29
  26.4%
29
  26.1%
85
  25.4%
Male
86
  76.1%
81
  73.6%
82
  73.9%
249
  74.6%
Age Customized, by Disease Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 110 participants 111 participants 334 participants
Younger than 65 years (NSCLC patients) 44 44 40 128
65 years and older (NSCLC patients) 26 24 26 76
Younger than 65 years (SCLC patients) 35 29 36 100
65 years and older (SCLC patients) 8 13 9 30
[1]
Measure Description: NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer
Gender, by Disease Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 110 participants 111 participants 334 participants
Female (NSCLC patients) 17 19 17 53
Male (NSCLC patients) 53 49 49 151
Female (SCLC patients) 10 10 12 32
Male (SCLC patients) 33 32 33 98
[1]
Measure Description: NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer
Disease Stage at Study Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 110 participants 111 participants 334 participants
Stage IIIB (NSCLC patients) 11 7 17 35
Stage IV (NSCLC patients) 59 61 49 169
Extensive (SCLC patients) 43 42 44 129
Recurrent disease (SCLC patients) 0 0 1 1
[1]
Measure Description: 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.
Cell Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 110 participants 111 participants 334 participants
Adenocarcinoma (NSCLC patients) 35 30 38 103
Bronchoalveolar carcinoma (NSCLC patients) 1 1 0 2
Large-cell carcinoma (NSCLC patients) 6 11 7 24
Other (NSCLC patients) 6 4 3 13
Squamous-cell carcinoma (NSCLC patients) 21 21 15 57
Unknown (NSCLC patients) 1 1 3 5
Other (SCLC patients) 2 2 0 4
Small-cell carcinoma (SCLC patients) 41 38 45 124
Unknown (SCLC patients) 0 1 0 1
Not reported (SCLC patients) 0 1 0 1
[1]
Measure Description: NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer
1.Primary Outcome
Title Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with NSCLC who were randomized to a treatment group.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 70 68 66
Median (95% Confidence Interval)
Unit of Measure: Months
5.52
(4.17 to 6.74)
5.68
(4.76 to 7.79)
4.63
(4.14 to 5.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1302
Comments [Not Specified]
Method 1-sided log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.806
Confidence Interval (2-Sided) 95%
0.553 to 1.174
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ipilimumab + Paclitaxel/Carboplatin (Sequential), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0473
Comments [Not Specified]
Method 1-sided log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.724
Confidence Interval (2-Sided) 95%
0.495 to 1.059
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria
Hide Description 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.
Time Frame Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All NSCLC participants who were randomized to a treatment group.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 70 68 66
Mean (95% Confidence Interval)
Unit of Measure: Months
4.11
(2.76 to 5.32)
5.13
(4.17 to 5.72)
4.21
(2.76 to 5.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2502
Comments [Not Specified]
Method One-sided log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.882
Confidence Interval (2-Sided) 95%
0.612 to 1.271
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0240
Comments [Not Specified]
Method One-sided log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.691
Confidence Interval (2-Sided) 95%
0.478 to 0.999
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival in Participants With NSCLC
Hide Description 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.
Time Frame Randomization date to date of death (of censored, maximum reached: 26.5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All NSCLC participants who were randomized to a treatment group.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 70 68 66
Median (95% Confidence Interval)
Unit of Measure: Months
9.69
(7.59 to 12.48)
12.22
(9.26 to 14.39)
8.28
(6.80 to 12.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4759
Comments [Not Specified]
Method 1-sided log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.988
Confidence Interval (2-Sided) 95%
0.669 to 1.460
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2340
Comments [Not Specified]
Method 1-sided log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.866
Confidence Interval (2-Sided) 95%
0.587 to 1.278
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC
Hide Description 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.
Time Frame Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to a treatment group.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 113 110 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
BORR (mWHO criteria) NSCLC cohort (n=70, 68, 66)
21.4
(12.5 to 32.29)
32.4
(21.5 to 44.8)
13.6
(6.4 to 24.3)
BORR (mWHO criteria) SCLC cohort (n=43, 42, 45)
32.6
(19.1 to 48.5)
57.1
(41.0 to 72.3)
48.9
(33.7 to 64.2)
5.Secondary Outcome
Title Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)
Hide Description 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.
Time Frame Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to a treatment group.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 113 110 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
irBORR ( irRC) NSCLC cohort (n=70, 68, 66)
21.4
(12.5 to 32.29)
32.4
(21.5 to 44.8)
18.2
(9.8 to 29.6)
irBORR (irRC) SCLC cohort (n=43, 42, 45)
48.8
(33.3 to 64.5)
71.4
(55.4 to 84.3)
53.3
(37.9 to 68.3)
6.Secondary Outcome
Title Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to a treatment group.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 113 110 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
irDCR (irRC) NSCLC cohort (n=70, 68, 66)
70.0
(57.9 to 80.4)
86.8
(76.4 to 93.8)
81.8
(70.4 to 90.2)
DCR (mWHO criteria) NSCLC cohort (n=70, 68, 66)
57.1
(44.7 to 68.9)
77.9
(66.2 to 87.1)
72.7
(60.4 to 83.0)
rDCR (irRC) SCLC cohort (n=43, 42, 45)
81.4
(66.6 to 91.6)
92.9
(80.5 to 98.5)
95.6
(84.9 to 99.5)
DCR (mWHO criteria) SCLC cohort (n=43, 42, 45)
69.8
(53.9 to 82.8)
81.0
(65.9 to 91.4)
93.3
(81.7 to 98.6)
7.Secondary Outcome
Title Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC
Hide Description 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.
Time Frame Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to a treatment group.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 113 110 111
Median (95% Confidence Interval)
Unit of Measure: Months
irDoR (irRC) NSCLC cohort (n=70, 63, 62)
6.70
(4.21 to 8.51)
5.55
(4.27 to 6.74)
4.01
(4.01 to 5.72)
DoR (mWHO criteria) NSCLC cohort (n=70, 63, 62)
5.42
(4.21 to 7.43)
5.55
(4.27 to 6.74)
4.01
(3.94 to 5.59)
irDoR (irRC) SCLC cohort (n=43, 42, 45)
5.95
(4.53 to 10.8)
5.78
(4.44 to 6.67)
4.21
(3.91 to 6.41)
DoR (mWHO criteria) SCLC cohort (n=43, 42, 45)
7.62
(4.90 to 11.1)
5.78
(3.94 to 6.57)
4.21
(3.91 to 5.95)
8.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 71 67 65
Measure Type: Number
Unit of Measure: Participants
Deaths (total) 52 50 51
Deaths within 30 days of last dose of study drug 11 7 8
Deaths within 70 days of last dose of study drug 21 16 18
SAEs (total) 49 36 33
SAEs, Grade 3 17 16 9
SAEs, Grade 4 10 4 5
SAEs, Grade 5 20 15 18
SAEs, Drug-related 20 13 11
SAEs, Drug-related Grade 5 2 1 2
AEs leading to discontinuation (disc) (total) 28 19 15
AEs leading to disc, Drug-related (all) 16 7 8
AEs leading to disc, Drug-related Grade 3 9 6 4
AEs leading to disc, Drug-related Grade 4 1 0 0
AEs leading to disc, Drug-related Grade 5 1 0 1
AEs (total) 71 64 64
AEs, Grades 3 and 4 40 36 26
AEs, Drug-related Any Grade 56 56 54
AEs, Drug-related Grades 3 and 4 29 26 24
AEs, Drug-related Grade 5 2 1 2
9.Secondary Outcome
Title Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade
Hide Description CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 71 67 65
Measure Type: Number
Unit of Measure: Percentage of participants
White blood cell count, Grades 3 and 4 7.7 6.2 3.2
Hemoglobin, Any grade 90.8 98.5 90.2
Hemoglobin, Grades 3 and 4 10.8 6.2 6.3
ANC, Grades 3 and 4 7.7 1.5 9.5
Platelets, Grades 3 and 4 1.5 3.1 9.5
10.Secondary Outcome
Title irPFS in Participants With SCLC Per irRC
Hide Description IRC performed TA.
Time Frame Randomization date to date of irPD or death (maximum reached: 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with SCLC who were randomized to a treatment group.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 43 42 45
Mean (95% Confidence Interval)
Unit of Measure: Months
5.68
(5.19 to 6.87)
6.44
(5.29 to 7.75)
5.26
(4.67 to 5.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1098
Comments [Not Specified]
Method 1-sided log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.751
Confidence Interval (2-Sided) 95%
0.475 to 1.188
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ipilimumab + Paclitaxel/Carboplatin (Sequential), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0282
Comments [Not Specified]
Method 1-sided log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.640
Confidence Interval (2-Sided) 95%
0.403 to 1.1016
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 65 65 62
Measure Type: Number
Unit of Measure: Participants
Alanine aminotransferase (ALT), Grade 1 24 15 19
ALT, Grade 2 2 4 3
ALT, Grades 3 and 4 1 1 1
Aspartate aminotransferase (AST), Grade 1 16 18 20
AST, Grade 2 0 2 0
AST, Grades 3 and 4 1 1 1
Total bilirubin, Grade 1 1 3 2
Total bilirubin, Grade 2 3 2 1
Total bilirubin, Grades 3 and 4 0 0 0
Alkaline phosphatase, Grade 1 24 28 24
Alkaline phosphatase, Grade 2 1 2 3
Alkaline phosphatase, Grades 3 and 4 0 1 1
12.Secondary Outcome
Title Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 71 67 65
Measure Type: Number
Unit of Measure: Participants
Vital sign measurements 0 0 0
Physical examination findings 0 0 0
13.Secondary Outcome
Title Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade
Hide Description 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.
Time Frame At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 71 67 65
Measure Type: Number
Unit of Measure: Percentage of participants
Lipase, Grades 3 and 4 7.7 6.2 3.2
Amylase, Grades 3 and 4 1.5 4.6 1.6
14.Secondary Outcome
Title Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline
Hide Description 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.
Time Frame Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 61 56
Measure Type: Number
Unit of Measure: Participants
2 1
15.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with SCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 42 42 44
Measure Type: Number
Unit of Measure: Participants
Deaths (total) 37 31 35
Deaths within 30 days of last dose of study drug 6 2 1
Deaths within 70 days of last dose of study drug 13 7 8
SAEs (total) 25 21 20
SAEs, Grade 3 7 6 4
SAEs, Grade 4 3 4 4
SAEs, Grade 5 12 7 7
SAEs, Drug-related 10 12 6
SAEs, Drug-related Grade 5 1 0 0
AEs leading to discontinuation (disc) (total) 14 13 12
AEs leading to disc, Drug-related (all) 9 7 7
AEs leading to disc, Drug-related Grade 3 3 3 4
AEs leading to disc, Drug-related Grade 4 2 2 0
AEs leading to disc, Drug-related Grade 5 1 0 0
AEs (total) 41 40 43
AEs, Grades 3 and 4 19 22 19
AEs, Grade 5 12 7 7
AEs, Drug-related (all) 36 40 40
AEs, Drug-related,Grades 3 and 4 18 21 13
AEs, Drug-related, Grade 5 1 0 0
16.Secondary Outcome
Title Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade
Hide Description CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.
Time Frame At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 42 42 44
Measure Type: Number
Unit of Measure: Participants
White blood cells, Grade 1 (n=39, 42, 43) 7 11 13
White blood cells, Grade 2 (n= 39, 42, 43) 10 9 7
White blood cells, Grades 3 (n= 39, 42, 43) 0 2 0
White blood cells, Grade 4 (n= 39, 42, 43) 0 0 0
Absolute neutrophil count, Grade 1 (n= 39, 42, 43) 8 8 8
Absolute neutrophil count, Grade 2 (n= 39, 42, 43) 8 9 91
Absolute neutrophil count, Grade 3 (n= 39, 42, 43) 2 2 1
Absolute neutrophil count, Grade 4 (n= 39, 42, 43) 1 2 0
Platelet count, Grade 1 (n= 39, 42, 43) 15 18 23
Platelet count, Grade 2 (n= 39, 42, 43) 2 3 3
Platelet count, Grade 3 (n= 39, 42, 43) 1 2 1
Platelet count, Grade 4 (n= 39, 42, 43) 0 1 0
Hemoglobin, Grade 1 (n= 39, 42, 43) 26 24 25
Hemoglobin, Grade 2 (n= 39, 42, 43) 8 10 11
Hemoglobin, Grade 3 (n= 39, 42, 43) 2 2 3
Hemoglobin, Grade 4 (n= 39, 42, 43) 0 2 0
17.Secondary Outcome
Title Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade
Hide Description 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.
Time Frame At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 42 42 44
Measure Type: Number
Unit of Measure: Participants
ALT, Grade 1 12 12 8
ALT, Grade 2 2 3 1
ALT, Grades 3 & 4 7 2 0
AST, Grade 1 11 13 12
AST, Grade 2 4 1 2
AST, Grades 3 & 4 5 3 0
Total bilirubin, Grade 1 4 5 3
Total bilirubin, Grade 2 1 0 0
Total bilirubin, Grades 3 & 4 1 0 0
ALK, Grade 1 15 14 16
ALK, Grade 2 1 3 2
ALK, Grades 3 & 4 0 0 0
18.Secondary Outcome
Title Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade
Hide Description 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.
Time Frame At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 42 42 44
Measure Type: Number
Unit of Measure: Percentage of participants
Lipase, Grades 3 and 4 7.7 16.7 11.6
Amylase, Grades 3 and 4 5.1 4.8 4.7
Creatinine, Grades 3 and 4 0 0 0
19.Secondary Outcome
Title Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria
Hide Description 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.
Time Frame Randomization date to date of progression or death (of censored, maximum reached: 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with SCLC who were randomized to a treatment group.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 43 42 45
Mean (95% Confidence Interval)
Unit of Measure: Months
3.89
(2.89 to 5.85)
5.22
(4.14 to 6.57)
5.19
(4.40 to 5.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3846
Comments [Not Specified]
Method 1-sided Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.933
Confidence Interval (2-Sided) 95%
0.588 to 1.481
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3700
Comments [Not Specified]
Method 1-sided Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.927
Confidence Interval (2-Sided) 95%
0.591 to 1.453
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings
Hide Description 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.
Time Frame Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 42 42 44
Measure Type: Number
Unit of Measure: Participants
Vital sign measurements 0 0 0
Physical examination findings 0 0 0
21.Secondary Outcome
Title Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline
Hide Description 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.
Time Frame Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Ipilimumab + Paclitaxel/Carboplatin (Sequential)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 38 41
Measure Type: Number
Unit of Measure: Participants
Positive at any timepoint (n=42, 42) 2 3
Positive postbaseline (n=38, 41) 2 0
22.Secondary Outcome
Title Overall Survival in Participants With SCLC
Hide Description 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.
Time Frame Randomization date to date of death (of censored, maximum reached: 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with SCLC who were randomized to a treatment group.
Arm/Group Title Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) Placebo + Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 43 42 45
Median (95% Confidence Interval)
Unit of Measure: Months
3.89
(2.89 to 5.85)
5.22
(4.14 to 6.57)
5.19
(4.40 to 5.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4132
Comments [Not Specified]
Method 1-sided Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.947
Confidence Interval (2-Sided) 95%
0.585 to 1.536
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent), Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential), Placebo + Paclitaxel/Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1287
Comments [Not Specified]
Method 1-sided Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.753
Confidence Interval (2-Sided) 95%
0.461 to 1.232
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC Placebo + Paclitaxel/Carboplatin NSCLC Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC Placebo + Paclitaxel/Carboplatin SCLC
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC Placebo + Paclitaxel/Carboplatin NSCLC Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC Placebo + Paclitaxel/Carboplatin SCLC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC Placebo + Paclitaxel/Carboplatin NSCLC Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC Placebo + Paclitaxel/Carboplatin SCLC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/71 (69.01%)   36/67 (53.73%)   33/65 (50.77%)   25/42 (59.52%)   21/42 (50.00%)   20/44 (45.45%) 
Blood and lymphatic system disorders             
ANAEMIA  1  4/71 (5.63%)  4/67 (5.97%)  1/65 (1.54%)  0/42 (0.00%)  2/42 (4.76%)  2/44 (4.55%) 
FEBRILE NEUTROPENIA  1  2/71 (2.82%)  1/67 (1.49%)  2/65 (3.08%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
LEUKOCYTOSIS  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
NEUTROPENIA  1  3/71 (4.23%)  0/67 (0.00%)  3/65 (4.62%)  0/42 (0.00%)  3/42 (7.14%)  3/44 (6.82%) 
PANCYTOPENIA  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
THROMBOCYTOPENIA  1  1/71 (1.41%)  0/67 (0.00%)  2/65 (3.08%)  0/42 (0.00%)  3/42 (7.14%)  1/44 (2.27%) 
LEUKOPENIA  1  1/71 (1.41%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Cardiac disorders             
PERICARDIAL EFFUSION  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
ACUTE MYOCARDIAL INFARCTION  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
ATRIAL FIBRILLATION  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
CARDIAC FAILURE  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
TACHYARRHYTHMIA  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
ANGINA PECTORIS  1  0/71 (0.00%)  2/67 (2.99%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
MYOCARDIAL INFARCTION  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
CARDIAC FAILURE CONGESTIVE  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
CARDIO-RESPIRATORY ARREST  1  0/71 (0.00%)  2/67 (2.99%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
VENTRICULAR FIBRILLATION  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
Congenital, familial and genetic disorders             
TRACHEO-OESOPHAGEAL FISTULA  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
ICHTHYOSIS  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Ear and labyrinth disorders             
VERTIGO  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Endocrine disorders             
HYPOPITUITARISM  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
HYPOPHYSITIS  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Eye disorders             
OPTIC ISCHAEMIC NEUROPATHY  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
MACULAR CYST  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Gastrointestinal disorders             
NAUSEA  1  0/71 (0.00%)  1/67 (1.49%)  2/65 (3.08%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
COLITIS  1  0/71 (0.00%)  2/67 (2.99%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
CONSTIPATION  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
DYSPHAGIA  1  0/71 (0.00%)  2/67 (2.99%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
VOMITING  1  0/71 (0.00%)  2/67 (2.99%)  2/65 (3.08%)  0/42 (0.00%)  0/42 (0.00%)  2/44 (4.55%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
ILEAL PERFORATION  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
SALIVARY GLAND CALCULUS  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
ABDOMINAL DISTENSION  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
DIARRHOEA  1  7/71 (9.86%)  5/67 (7.46%)  4/65 (6.15%)  1/42 (2.38%)  2/42 (4.76%)  1/44 (2.27%) 
DUODENAL ULCER  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
ENTERITIS  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
GASTROINTESTINAL PERFORATION  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
OESOPHAGEAL DISORDER  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PANCREATITIS  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
ABDOMINAL HERNIA  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
EROSIVE OESOPHAGITIS  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
GASTRITIS EROSIVE  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
RECTAL HAEMORRHAGE  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
General disorders             
GENERAL PHYSICAL HEALTH DETERIORATION  1  2/71 (2.82%)  1/67 (1.49%)  0/65 (0.00%)  2/42 (4.76%)  0/42 (0.00%)  0/44 (0.00%) 
MULTI-ORGAN FAILURE  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
PYREXIA  1  1/71 (1.41%)  3/67 (4.48%)  0/65 (0.00%)  4/42 (9.52%)  0/42 (0.00%)  0/44 (0.00%) 
ASTHENIA  1  1/71 (1.41%)  1/67 (1.49%)  1/65 (1.54%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
OEDEMA PERIPHERAL  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
CHEST PAIN  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
PAIN  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
DEATH  1  2/71 (2.82%)  4/67 (5.97%)  2/65 (3.08%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
FATIGUE  1  1/71 (1.41%)  2/67 (2.99%)  1/65 (1.54%)  1/42 (2.38%)  1/42 (2.38%)  1/44 (2.27%) 
LOCALISED OEDEMA  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
SUDDEN DEATH  1  0/71 (0.00%)  2/67 (2.99%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
DISEASE PROGRESSION  1  5/71 (7.04%)  1/67 (1.49%)  4/65 (6.15%)  1/42 (2.38%)  0/42 (0.00%)  1/44 (2.27%) 
DROWNING  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Hepatobiliary disorders             
AUTOIMMUNE HEPATITIS  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
HEPATITIS  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
HEPATITIS ACUTE  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
BILIARY COLIC  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
HEPATOTOXICITY  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
BILE DUCT STENOSIS  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Immune system disorders             
HYPERSENSITIVITY  1  1/71 (1.41%)  1/67 (1.49%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
ANAPHYLACTIC REACTION  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Infections and infestations             
GASTROENTERITIS SHIGELLA  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
SEPSIS  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  1/42 (2.38%)  1/44 (2.27%) 
SIALOADENITIS  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
URINARY TRACT INFECTION  1  1/71 (1.41%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
ERYSIPELAS  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
GASTROENTERITIS  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
CELLULITIS  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
FEBRILE INFECTION  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
GASTROINTESTINAL INFECTION  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
PSEUDOMONAL SEPSIS  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
BRONCHITIS  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
SEPTIC SHOCK  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
MENINGITIS  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
LOBAR PNEUMONIA  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PLEURAL INFECTION BACTERIAL  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PNEUMONIA  1  5/71 (7.04%)  2/67 (2.99%)  2/65 (3.08%)  0/42 (0.00%)  0/42 (0.00%)  2/44 (4.55%) 
Injury, poisoning and procedural complications             
UPPER LIMB FRACTURE  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
FEMUR FRACTURE  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PROCEDURAL PAIN  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
HIP FRACTURE  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Investigations             
ALANINE AMINOTRANSFERASE INCREASED  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  2/42 (4.76%)  1/42 (2.38%)  0/44 (0.00%) 
WEIGHT DECREASED  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  2/42 (4.76%)  1/42 (2.38%)  0/44 (0.00%) 
HEPATIC ENZYME INCREASED  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
Metabolism and nutrition disorders             
METABOLIC ACIDOSIS  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
DEHYDRATION  1  2/71 (2.82%)  2/67 (2.99%)  4/65 (6.15%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
CACHEXIA  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
HYPERGLYCAEMIA  1  1/71 (1.41%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
HYPERCALCAEMIA  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
MALNUTRITION  1  0/71 (0.00%)  1/67 (1.49%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
HYPOKALAEMIA  1  1/71 (1.41%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
ACIDOSIS  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
HYPOCALCAEMIA  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
HYPONATRAEMIA  1  1/71 (1.41%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Musculoskeletal and connective tissue disorders             
MUSCULAR WEAKNESS  1  0/71 (0.00%)  1/67 (1.49%)  3/65 (4.62%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PAIN IN EXTREMITY  1  0/71 (0.00%)  1/67 (1.49%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PATHOLOGICAL FRACTURE  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
MALIGNANT PLEURAL EFFUSION  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
METASTATIC NEOPLASM  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
TUMOUR PAIN  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
LUNG NEOPLASM  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
MALIGNANT NEOPLASM PROGRESSION  1  2/71 (2.82%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PERICARDIAL EFFUSION MALIGNANT  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
LUNG CANCER METASTATIC  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
NEOPLASM PROGRESSION  1  3/71 (4.23%)  1/67 (1.49%)  3/65 (4.62%)  4/42 (9.52%)  2/42 (4.76%)  3/44 (6.82%) 
NON-SMALL CELL LUNG CANCER  1  0/71 (0.00%)  2/67 (2.99%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
METASTASES TO CENTRAL NERVOUS SYSTEM  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
SQUAMOUS CELL CARCINOMA  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
LUNG NEOPLASM MALIGNANT  1  4/71 (5.63%)  4/67 (5.97%)  5/65 (7.69%)  4/42 (9.52%)  6/42 (14.29%)  5/44 (11.36%) 
Nervous system disorders             
SYNCOPE  1  1/71 (1.41%)  1/67 (1.49%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
CEREBRAL HAEMORRHAGE  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
DYSARTHRIA  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
HEADACHE  1  0/71 (0.00%)  2/67 (2.99%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
HYDROCEPHALUS  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
ATAXIA  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
EPILEPSY  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
CERVICAL CORD COMPRESSION  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
CONVULSION  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  1/42 (2.38%)  0/42 (0.00%)  1/44 (2.27%) 
GRAND MAL CONVULSION  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PERIPHERAL SENSORIMOTOR NEUROPATHY  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
BASAL GANGLIA HAEMORRHAGE  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
MONOPLEGIA  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
NEUROPATHY PERIPHERAL  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PERIPHERAL MOTOR NEUROPATHY  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PERIPHERAL SENSORY NEUROPATHY  1  0/71 (0.00%)  1/67 (1.49%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
OCCIPITAL NEURALGIA  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Psychiatric disorders             
CONFUSIONAL STATE  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Renal and urinary disorders             
RENAL FAILURE ACUTE  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
ACUTE RESPIRATORY FAILURE  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PLEURAL EFFUSION  1  3/71 (4.23%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
PNEUMOTHORAX  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
PULMONARY EMBOLISM  1  4/71 (5.63%)  2/67 (2.99%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
BRONCHITIS CHRONIC  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
BRONCHOSPASM  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
OBSTRUCTIVE AIRWAYS DISORDER  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
HAEMOPTYSIS  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
PNEUMONIA ASPIRATION  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
MEDIASTINAL DISORDER  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PULMONARY HAEMORRHAGE  1  0/71 (0.00%)  0/67 (0.00%)  3/65 (4.62%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
DYSPNOEA  1  4/71 (5.63%)  2/67 (2.99%)  2/65 (3.08%)  2/42 (4.76%)  1/42 (2.38%)  1/44 (2.27%) 
LUNG DISORDER  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Skin and subcutaneous tissue disorders             
ERYTHEMA MULTIFORME  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
RASH  1  1/71 (1.41%)  1/67 (1.49%)  1/65 (1.54%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
RASH MACULAR  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
TOXIC EPIDERMAL NECROLYSIS  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
DERMATITIS EXFOLIATIVE  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/44 (0.00%) 
Vascular disorders             
ARTERIAL THROMBOSIS  1  0/71 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
HYPOTENSION  1  1/71 (1.41%)  1/67 (1.49%)  2/65 (3.08%)  1/42 (2.38%)  0/42 (0.00%)  1/44 (2.27%) 
PERIPHERAL ISCHAEMIA  1  1/71 (1.41%)  0/67 (0.00%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
THROMBOPHLEBITIS  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
DEEP VEIN THROMBOSIS  1  1/71 (1.41%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
VENOUS THROMBOSIS  1  0/71 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
HYPERTENSION  1  0/71 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC Placebo + Paclitaxel/Carboplatin NSCLC Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC Placebo + Paclitaxel/Carboplatin SCLC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   63/71 (88.73%)   63/67 (94.03%)   59/65 (90.77%)   36/42 (85.71%)   39/42 (92.86%)   41/44 (93.18%) 
Blood and lymphatic system disorders             
ANAEMIA  1  22/71 (30.99%)  15/67 (22.39%)  19/65 (29.23%)  13/42 (30.95%)  12/42 (28.57%)  10/44 (22.73%) 
NEUTROPENIA  1  11/71 (15.49%)  15/67 (22.39%)  15/65 (23.08%)  11/42 (26.19%)  8/42 (19.05%)  6/44 (13.64%) 
THROMBOCYTOPENIA  1  10/71 (14.08%)  13/67 (19.40%)  12/65 (18.46%)  5/42 (11.90%)  6/42 (14.29%)  7/44 (15.91%) 
LEUKOPENIA  1  6/71 (8.45%)  4/67 (5.97%)  7/65 (10.77%)  6/42 (14.29%)  4/42 (9.52%)  2/44 (4.55%) 
Cardiac disorders             
TACHYCARDIA  1  4/71 (5.63%)  1/67 (1.49%)  0/65 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  3/44 (6.82%) 
Eye disorders             
VISION BLURRED  1  5/71 (7.04%)  2/67 (2.99%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Gastrointestinal disorders             
NAUSEA  1  22/71 (30.99%)  27/67 (40.30%)  22/65 (33.85%)  11/42 (26.19%)  13/42 (30.95%)  13/44 (29.55%) 
ABDOMINAL PAIN UPPER  1  4/71 (5.63%)  3/67 (4.48%)  2/65 (3.08%)  1/42 (2.38%)  1/42 (2.38%)  1/44 (2.27%) 
CONSTIPATION  1  13/71 (18.31%)  10/67 (14.93%)  15/65 (23.08%)  5/42 (11.90%)  4/42 (9.52%)  9/44 (20.45%) 
DYSPHAGIA  1  1/71 (1.41%)  5/67 (7.46%)  3/65 (4.62%)  1/42 (2.38%)  1/42 (2.38%)  2/44 (4.55%) 
VOMITING  1  19/71 (26.76%)  14/67 (20.90%)  13/65 (20.00%)  5/42 (11.90%)  5/42 (11.90%)  4/44 (9.09%) 
ABDOMINAL PAIN  1  4/71 (5.63%)  1/67 (1.49%)  8/65 (12.31%)  0/42 (0.00%)  4/42 (9.52%)  1/44 (2.27%) 
DIARRHOEA  1  21/71 (29.58%)  20/67 (29.85%)  14/65 (21.54%)  12/42 (28.57%)  14/42 (33.33%)  7/44 (15.91%) 
DYSPEPSIA  1  5/71 (7.04%)  1/67 (1.49%)  4/65 (6.15%)  1/42 (2.38%)  0/42 (0.00%)  1/44 (2.27%) 
STOMATITIS  1  1/71 (1.41%)  1/67 (1.49%)  0/65 (0.00%)  4/42 (9.52%)  1/42 (2.38%)  3/44 (6.82%) 
General disorders             
PYREXIA  1  17/71 (23.94%)  11/67 (16.42%)  7/65 (10.77%)  6/42 (14.29%)  6/42 (14.29%)  5/44 (11.36%) 
ASTHENIA  1  14/71 (19.72%)  20/67 (29.85%)  11/65 (16.92%)  4/42 (9.52%)  7/42 (16.67%)  8/44 (18.18%) 
CHILLS  1  4/71 (5.63%)  1/67 (1.49%)  6/65 (9.23%)  2/42 (4.76%)  1/42 (2.38%)  0/44 (0.00%) 
OEDEMA PERIPHERAL  1  8/71 (11.27%)  6/67 (8.96%)  6/65 (9.23%)  0/42 (0.00%)  3/42 (7.14%)  4/44 (9.09%) 
CHEST PAIN  1  9/71 (12.68%)  8/67 (11.94%)  11/65 (16.92%)  4/42 (9.52%)  12/42 (28.57%)  9/44 (20.45%) 
PAIN  1  7/71 (9.86%)  8/67 (11.94%)  7/65 (10.77%)  3/42 (7.14%)  6/42 (14.29%)  5/44 (11.36%) 
FATIGUE  1  26/71 (36.62%)  24/67 (35.82%)  24/65 (36.92%)  15/42 (35.71%)  15/42 (35.71%)  19/44 (43.18%) 
Infections and infestations             
PNEUMONIA  1  7/71 (9.86%)  1/67 (1.49%)  1/65 (1.54%)  3/42 (7.14%)  1/42 (2.38%)  0/44 (0.00%) 
Investigations             
ALANINE AMINOTRANSFERASE INCREASED  1  4/71 (5.63%)  6/67 (8.96%)  2/65 (3.08%)  4/42 (9.52%)  4/42 (9.52%)  0/44 (0.00%) 
WEIGHT DECREASED  1  10/71 (14.08%)  10/67 (14.93%)  5/65 (7.69%)  6/42 (14.29%)  7/42 (16.67%)  3/44 (6.82%) 
HAEMOGLOBIN DECREASED  1  3/71 (4.23%)  5/67 (7.46%)  2/65 (3.08%)  0/42 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  4/71 (5.63%)  5/67 (7.46%)  3/65 (4.62%)  4/42 (9.52%)  5/42 (11.90%)  0/44 (0.00%) 
Metabolism and nutrition disorders             
DECREASED APPETITE  1  13/71 (18.31%)  10/67 (14.93%)  11/65 (16.92%)  9/42 (21.43%)  8/42 (19.05%)  11/44 (25.00%) 
DEHYDRATION  1  4/71 (5.63%)  5/67 (7.46%)  3/65 (4.62%)  1/42 (2.38%)  2/42 (4.76%)  3/44 (6.82%) 
HYPERGLYCAEMIA  1  4/71 (5.63%)  2/67 (2.99%)  1/65 (1.54%)  1/42 (2.38%)  0/42 (0.00%)  1/44 (2.27%) 
HYPERCALCAEMIA  1  4/71 (5.63%)  0/67 (0.00%)  2/65 (3.08%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
HYPOMAGNESAEMIA  1  5/71 (7.04%)  1/67 (1.49%)  6/65 (9.23%)  1/42 (2.38%)  2/42 (4.76%)  1/44 (2.27%) 
HYPOKALAEMIA  1  4/71 (5.63%)  6/67 (8.96%)  5/65 (7.69%)  1/42 (2.38%)  2/42 (4.76%)  0/44 (0.00%) 
HYPONATRAEMIA  1  3/71 (4.23%)  2/67 (2.99%)  4/65 (6.15%)  1/42 (2.38%)  1/42 (2.38%)  0/44 (0.00%) 
Musculoskeletal and connective tissue disorders             
ARTHRALGIA  1  18/71 (25.35%)  11/67 (16.42%)  10/65 (15.38%)  13/42 (30.95%)  23/42 (54.76%)  15/44 (34.09%) 
PAIN IN EXTREMITY  1  7/71 (9.86%)  9/67 (13.43%)  5/65 (7.69%)  5/42 (11.90%)  6/42 (14.29%)  4/44 (9.09%) 
MUSCULOSKELETAL PAIN  1  3/71 (4.23%)  7/67 (10.45%)  7/65 (10.77%)  1/42 (2.38%)  2/42 (4.76%)  6/44 (13.64%) 
BONE PAIN  1  5/71 (7.04%)  5/67 (7.46%)  6/65 (9.23%)  4/42 (9.52%)  4/42 (9.52%)  6/44 (13.64%) 
BACK PAIN  1  11/71 (15.49%)  6/67 (8.96%)  9/65 (13.85%)  2/42 (4.76%)  3/42 (7.14%)  3/44 (6.82%) 
MYALGIA  1  11/71 (15.49%)  9/67 (13.43%)  2/65 (3.08%)  3/42 (7.14%)  5/42 (11.90%)  5/44 (11.36%) 
Nervous system disorders             
DIZZINESS  1  9/71 (12.68%)  7/67 (10.45%)  5/65 (7.69%)  1/42 (2.38%)  2/42 (4.76%)  2/44 (4.55%) 
HEADACHE  1  8/71 (11.27%)  9/67 (13.43%)  8/65 (12.31%)  3/42 (7.14%)  10/42 (23.81%)  5/44 (11.36%) 
DYSGEUSIA  1  7/71 (9.86%)  2/67 (2.99%)  3/65 (4.62%)  0/42 (0.00%)  2/42 (4.76%)  1/44 (2.27%) 
NEUROPATHY PERIPHERAL  1  12/71 (16.90%)  10/67 (14.93%)  19/65 (29.23%)  6/42 (14.29%)  12/42 (28.57%)  5/44 (11.36%) 
PERIPHERAL MOTOR NEUROPATHY  1  1/71 (1.41%)  0/67 (0.00%)  3/65 (4.62%)  0/42 (0.00%)  3/42 (7.14%)  1/44 (2.27%) 
PERIPHERAL SENSORY NEUROPATHY  1  7/71 (9.86%)  14/67 (20.90%)  9/65 (13.85%)  10/42 (23.81%)  15/42 (35.71%)  14/44 (31.82%) 
Psychiatric disorders             
ANXIETY  1  2/71 (2.82%)  2/67 (2.99%)  7/65 (10.77%)  1/42 (2.38%)  1/42 (2.38%)  1/44 (2.27%) 
DEPRESSION  1  4/71 (5.63%)  2/67 (2.99%)  2/65 (3.08%)  0/42 (0.00%)  0/42 (0.00%)  2/44 (4.55%) 
INSOMNIA  1  8/71 (11.27%)  5/67 (7.46%)  5/65 (7.69%)  2/42 (4.76%)  3/42 (7.14%)  2/44 (4.55%) 
Respiratory, thoracic and mediastinal disorders             
HYPOXIA  1  5/71 (7.04%)  1/67 (1.49%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
EPISTAXIS  1  2/71 (2.82%)  2/67 (2.99%)  5/65 (7.69%)  1/42 (2.38%)  2/42 (4.76%)  0/44 (0.00%) 
COUGH  1  16/71 (22.54%)  18/67 (26.87%)  12/65 (18.46%)  9/42 (21.43%)  8/42 (19.05%)  8/44 (18.18%) 
HAEMOPTYSIS  1  6/71 (8.45%)  4/67 (5.97%)  4/65 (6.15%)  4/42 (9.52%)  3/42 (7.14%)  4/44 (9.09%) 
PRODUCTIVE COUGH  1  3/71 (4.23%)  0/67 (0.00%)  0/65 (0.00%)  4/42 (9.52%)  0/42 (0.00%)  0/44 (0.00%) 
DYSPHONIA  1  4/71 (5.63%)  2/67 (2.99%)  2/65 (3.08%)  1/42 (2.38%)  4/42 (9.52%)  1/44 (2.27%) 
DYSPNOEA  1  21/71 (29.58%)  11/67 (16.42%)  17/65 (26.15%)  16/42 (38.10%)  12/42 (28.57%)  17/44 (38.64%) 
OROPHARYNGEAL PAIN  1  0/71 (0.00%)  1/67 (1.49%)  4/65 (6.15%)  2/42 (4.76%)  2/42 (4.76%)  1/44 (2.27%) 
Skin and subcutaneous tissue disorders             
ERYTHEMA  1  4/71 (5.63%)  2/67 (2.99%)  1/65 (1.54%)  0/42 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
PRURITUS  1  14/71 (19.72%)  7/67 (10.45%)  4/65 (6.15%)  10/42 (23.81%)  9/42 (21.43%)  2/44 (4.55%) 
RASH  1  24/71 (33.80%)  9/67 (13.43%)  6/65 (9.23%)  16/42 (38.10%)  12/42 (28.57%)  3/44 (6.82%) 
DRY SKIN  1  4/71 (5.63%)  5/67 (7.46%)  1/65 (1.54%)  1/42 (2.38%)  0/42 (0.00%)  1/44 (2.27%) 
ALOPECIA  1  27/71 (38.03%)  32/67 (47.76%)  31/65 (47.69%)  24/42 (57.14%)  29/42 (69.05%)  28/44 (63.64%) 
Vascular disorders             
HYPOTENSION  1  4/71 (5.63%)  1/67 (1.49%)  8/65 (12.31%)  0/42 (0.00%)  2/42 (4.76%)  0/44 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00527735    
Other Study ID Numbers: CA184-041
First Submitted: September 7, 2007
First Posted: September 11, 2007
Results First Submitted: February 23, 2012
Results First Posted: July 16, 2012
Last Update Posted: July 18, 2018