Trial Outcomes & Findings for Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma (NCT NCT00636168)

NCT ID: NCT00636168

Last Updated: 2019-12-17

Results Overview

Recurrence free survival (RFS) was programmatically determined based on the disease recurrence data provided by the IRC and was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A participant who died without reported recurrence was considered to have recurrence on the date of death. For those participants who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. The primary analysis was event-driven and planned when at least 512 RFS events assessed per IRC were collected.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1211 participants
• Primary outcome timeframe: Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.
• Results posted on: 2019-12-17

Participant Flow

Protocol definition of Enrolled population: All 1211 participants who signed the Informed Consent Form; 951 were randomized to treatment and 945 were treated. Reasons for not being randomized: 193 were ineligible; 42 refused; 19 could not be randomized within 12 weeks after complete lymph node dissection; 6 due to other reasons.

Participant milestones

Measure	Ipilimumab 10mg/kg Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Randomized to Study Drug STARTED	475	476
Randomized to Study Drug COMPLETED	471	474
Randomized to Study Drug NOT COMPLETED	4	2
Treated With Study Drug STARTED	471	474
Treated With Study Drug COMPLETED	63	143
Treated With Study Drug NOT COMPLETED	408	331
Long Term Follow-Up STARTED	141	143
Long Term Follow-Up COMPLETED	130	129
Long Term Follow-Up NOT COMPLETED	11	14

Reasons for withdrawal

Measure	Ipilimumab 10mg/kg Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Randomized to Study Drug Withdrawal by Subject	2	2
Randomized to Study Drug Adverse Event	1	0
Randomized to Study Drug No longer meets study criteria	1	0
Treated With Study Drug Recurrence of disease	135	282
Treated With Study Drug Adverse Event	250	22
Treated With Study Drug Participant withdrew consent	16	21
Treated With Study Drug Poor/non-compliance	1	3
Treated With Study Drug Death	3	0
Treated With Study Drug Pregnancy	1	0
Treated With Study Drug No longer meets study criteria	1	0
Treated With Study Drug Other reason	1	3
Long Term Follow-Up Lost to Follow-up	3	3
Long Term Follow-Up Participant withdrew consent	0	2
Long Term Follow-Up Death	8	9

Baseline Characteristics

Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma

Baseline characteristics by cohort

Measure	Ipilimumab 10mg/kg n=475 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=476 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Total n=951 Participants Total of all reporting groups
Age, Continuous	50.7 years STANDARD_DEVIATION 12.90 • n=5 Participants	51.5 years STANDARD_DEVIATION 12.82 • n=7 Participants	51.1 years STANDARD_DEVIATION 12.86 • n=5 Participants
Sex: Female, Male Female	179 Participants n=5 Participants	183 Participants n=7 Participants	362 Participants n=5 Participants
Sex: Female, Male Male	296 Participants n=5 Participants	293 Participants n=7 Participants	589 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	470 Participants n=5 Participants	476 Participants n=7 Participants	946 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.

Population: Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization

Recurrence free survival (RFS) was programmatically determined based on the disease recurrence data provided by the IRC and was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A participant who died without reported recurrence was considered to have recurrence on the date of death. For those participants who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. The primary analysis was event-driven and planned when at least 512 RFS events assessed per IRC were collected.

Outcome measures

Measure	Ipilimumab 10mg/kg n=475 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=476 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population	26.09 months Interval 19.32 to 39.26	17.05 months Interval 13.4 to 21.62

PRIMARY outcome

Timeframe: Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years.

Population: Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization

Recurrence was defined as appearance of one or more new melanoma lesions: local, regional or distant metastasis. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. A participant who died without reported recurrence was considered to have recurred on the date of death. Disease was assessed at randomization and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression.

Outcome measures

Measure	Ipilimumab 10mg/kg n=475 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=476 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population	234 Participants Interval 19.32 to 39.26	294 Participants Interval 13.4 to 21.62

PRIMARY outcome

Timeframe: At years 1, 2, and 3

Population: Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization

Yearly recurrence-free survival rates, eg. at 1 year, defined as the probability that a participant was recurrence-free at 1 year following randomization, were estimated for each treatment group using the Kaplan-Meier product-limit method, along with their corresponding log-log transformed 95% confidence intervals. RFS was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A participant who died without reported recurrence was considered to have recurrence on the date of death. For those who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. CT and MRI were mandatory to establish recurrence.

Outcome measures

Measure	Ipilimumab 10mg/kg n=475 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=476 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population RFS Rate at 1 Year	63.50 Percentage of participants Interval 58.89 to 67.74	56.13 Percentage of participants Interval 51.52 to 60.47
Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population RFS Rate at 2 Years	51.45 Percentage of participants Interval 46.69 to 56.0	43.83 Percentage of participants Interval 39.27 to 48.28
Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population RFS Rate at 3 Years	46.48 Percentage of participants Interval 41.46 to 51.34	34.79 Percentage of participants Interval 30.12 to 39.5

SECONDARY outcome

Timeframe: From June 2008 to January 2016 (approximately 90 months)

Population: Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization

Distant Metastasis-Free Survival (DMFS) was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, DMFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. Disease was assessed at baseline (randomization) and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression.

Outcome measures

Measure	Ipilimumab 10mg/kg n=475 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=476 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population	48.30 Months Interval 35.45 to 71.56	27.47 Months Interval 21.91 to 34.79

SECONDARY outcome

Timeframe: From June 2008 to January 2016 (approximately 90 months)

Population: Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization

DMFS was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, DMFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. Disease was assessed at baseline (randomization) and every 12 weeks (2 weeks) for 3 years, then every 24 weeks until documented distant progression.

Outcome measures

Measure	Ipilimumab 10mg/kg n=475 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=476 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Number of Participants With Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population	227 Participants	279 Participants

SECONDARY outcome

Timeframe: At years 1, 2, 3, 4 and 5

Population: Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization

Yearly distant metastasis-free survival rates, e.g. at 1 year, defined as the probability that a participant was alive at 1 year following randomization, were estimated via the Kaplan-Meier method. Distant Metastasis-Free Survival (DMFS) was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment. Participants with disease at baseline were considered to have an event on the day of randomization.

Outcome measures

Measure	Ipilimumab 10mg/kg n=475 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=476 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population DMFS Rate at 5 Years	48.29 Percentage of participants Interval 43.36 to 53.04	38.90 Percentage of participants Interval 34.29 to 43.47
Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population DMFS Rate at 1 Year	74.27 Percentage of participants Interval 69.98 to 78.04	65.77 Percentage of participants Interval 61.27 to 69.88
Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population DMFS Rate at 2 Years	61.48 Percentage of participants Interval 56.75 to 65.85	53.26 Percentage of participants Interval 48.58 to 57.7
Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population DMFS Rate at 3 Years	53.90 Percentage of participants Interval 49.04 to 58.5	45.17 Percentage of participants Interval 40.53 to 49.7
Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population DMFS Rate at 4 Years	50.19 Percentage of participants Interval 45.3 to 54.87	41.48 Percentage of participants Interval 36.87 to 46.02

SECONDARY outcome

Timeframe: From June 2008 to January 2016 (approximately 90 months)

Population: Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization

OS was defined as the time from the date of randomization to the date of death. For those participants who had not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.

Outcome measures

Measure	Ipilimumab 10mg/kg n=475 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=476 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Overall Survival in the Intent to Treat (ITT) Population	86.60 Months Interval 86.6 to Upper limit was not reached because the number of participants with a followup of more than 7 years was too small	NA Months Interval 59.3 to Median and upper limit were not reached because the number of participants with a followup of more than 7 years was too small

SECONDARY outcome

Timeframe: From date of randomization to date of death, assessed up to 9 years

Population: Intent to Treat Population: All randomized participants,analyzed in the arm to which they were allocated by randomization

OS was defined as the time from the date of randomization to the date of death. For those participants who had not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.Yearly survival rates, e.g. at 3 years, defined as the probability that a participant was alive at 3 years following randomization, were estimated via the Kaplan-Meier method

Outcome measures

Measure	Ipilimumab 10mg/kg n=475 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=476 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Rate of Overall Survival (OS) OS Rate at 1 year	93.53 Percentage of participants Interval 90.88 to 95.43	87.72 Percentage of participants Interval 84.4 to 90.37
Rate of Overall Survival (OS) OS Rate at 2 years	82.55 Percentage of participants Interval 78.76 to 85.73	75.27 Percentage of participants Interval 71.1 to 78.92
Rate of Overall Survival (OS) OS Rate at 3 years	74.20 Percentage of participants Interval 69.9 to 77.98	65.43 Percentage of participants Interval 60.91 to 69.56
Rate of Overall Survival (OS) OS Rate at 4 years	67.79 Percentage of participants Interval 63.24 to 71.9	60.34 Percentage of participants Interval 55.72 to 64.64
Rate of Overall Survival (OS) OS Rate at 5 years	65.42 Percentage of participants Interval 60.8 to 69.64	54.43 Percentage of participants Interval 49.71 to 58.89
Rate of Overall Survival (OS) OS Rate at 7 years	60.0 Percentage of participants Interval 55.0 to 64.7	51.3 Percentage of participants Interval 46.5 to 55.9

SECONDARY outcome

Timeframe: Day 1 up to 70 days after last dose; up to 5 years

Population: Safety population: All randomized participants who received at least 1 dose of study therapy

AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. irAEs=unknown etiology consistent with an immune phenomenon, considered as causally related to drug. imARs=based on investigator's assessment of immune-mediated etiology [excluding novel maintenance events (ie, patients with imARs occurring for the first time during maintenance)]. 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 (D-R)=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death.

Outcome measures

Measure	Ipilimumab 10mg/kg n=471 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=474 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study AE leading to Discontinuation (Any Grade)	247 Participants	43 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study SAE (At least 5%, Any Grade)	257 Participants	128 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study D-R SAE (Any Grade)	217 Participants	10 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study irAE (Any Grade)	426 Participants	188 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study gastrointestinal irAE (Any Grade)	217 Participants	85 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study endocrine irAE (Any Grade)	178 Participants	38 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study liver irAE (Any Grade)	115 Participants	20 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study skin irAE (Any Grade)	298 Participants	99 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study neurological irAE (Any Grade)	21 Participants	9 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study other irAE (Any Grade)	111 Participants	23 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study imAR (Grade 3-4)	194 Participants	16 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study imAR (Grade 5)	1 Participants	0 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study enterocolitis imAR (Grade 5)	1 Participants	0 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study enterocolitis imAR (Grade 3-4)	76 Participants	4 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study endocrinopathy imAR (Grade 3-4)	39 Participants	1 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study hepatitis imAR (Grade 3-4)	51 Participants	1 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study dermatitis imAR (Grade 3-4)	19 Participants	2 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study neuropathy imAR (Grade 3-4)	10 Participants	0 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population On-study other imAR (Grade 3-4)	30 Participants	9 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population Any Death	162 Participants	214 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population Death within 70 days of last dose study drug	6 Participants	6 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population Death within 30 days of last dose study drug	1 Participants	0 Participants
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population Drug-related Deaths	4 Participants	0 Participants

SECONDARY outcome

Timeframe: SAEs and NSAEs: Day 1 up to 70 days after last dose(safety window). Deaths: All deaths regardless of 70 day safety window.Up to 10 years

Population: Safety population: All randomized participants who received at least 1 dose of study therapy

AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. 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.

Outcome measures

Measure	Ipilimumab 10mg/kg n=471 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=474 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Number of Participants With Serious Adverse Events (SAEs), Non-serious AEs (NSAEs) and Number of Deaths: Overall Study No. of deaths	173 Participants	223 Participants
Number of Participants With Serious Adverse Events (SAEs), Non-serious AEs (NSAEs) and Number of Deaths: Overall Study No. of participants with SAEs	257 Participants	128 Participants
Number of Participants With Serious Adverse Events (SAEs), Non-serious AEs (NSAEs) and Number of Deaths: Overall Study No of participants with NSAEs	441 Participants	382 Participants

SECONDARY outcome

Timeframe: Day 1 up to 70 days after last dose; up to 5 years

Population: All participants who received at least one dose of ipilimumab or placebo, adjusted for person-years (P-Y) of exposure; P-Y=467.4; P-Y=781.7 for ipilimumab and placebo, respectively.

P-Y = person-years of exposure. Incidence rate per 100 person-years of exposure (IR/100 P-Y) was calculated as event count * 100 /person-years of exposure. MedDRA Version: 19. Duplicate AEs have been eliminated and overlapping and contiguous occurrences of the same event have been collapsed.

Outcome measures

Measure	Ipilimumab 10mg/kg n=471 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=474 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Exposure Adjusted Incidence Rate of Adverse Events Including Multiple Occurrences of Unique Events	1171.8 Events per 100 person-years of exposure	465.0 Events per 100 person-years of exposure

SECONDARY outcome

Timeframe: Baseline up to 2 years from randomization

Population: All randomized participants (ITT) analyzed in the arm to which they were allocated by randomization were analyzed. At timepoint level, all randomized participants (ITT) with a measurement at the timepoint were analyzed.

Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scales linearly transformed to 0-100 scales. Higher scores for Global Health Status indicate better HRQoL. An increase from baseline indicates improvement in HRQoL compared to baseline. HRQoL was administered within 1 week prior to first dose (baseline) and on Days 22, 43, 64 (+/- 3 days), Week 24 and every 12 weeks up to 2 years, independent of disease progression.

Outcome measures

Measure	Ipilimumab 10mg/kg n=400 Participants Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).	Placebo n=421 Participants Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 48 Day 330	-3.67 units on a scale Standard Deviation 20.17	1.54 units on a scale Standard Deviation 18.87
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 60 Day 414	-5.30 units on a scale Standard Deviation 21.34	2.84 units on a scale Standard Deviation 17.05
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 72 day 498	-4.07 units on a scale Standard Deviation 23.19	1.18 units on a scale Standard Deviation 17.46
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 84 Day 582	-3.90 units on a scale Standard Deviation 22.06	1.84 units on a scale Standard Deviation 17.08
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 96 Day 666	-4.48 units on a scale Standard Deviation 21.71	1.36 units on a scale Standard Deviation 18.67
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 108 Day 750	-4.27 units on a scale Standard Deviation 20.35	2.45 units on a scale Standard Deviation 16.72
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 4 Day 22	-2.29 units on a scale Standard Deviation 15.96	1.33 units on a scale Standard Deviation 14.02
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 7, Day 43	-6.64 units on a scale Standard Deviation 20.44	-0.10 units on a scale Standard Deviation 16.75
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 10 Day 64	-9.06 units on a scale Standard Deviation 23.56	-0.23 units on a scale Standard Deviation 16.18
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 24 Day 162 (300, 347)	-4.33 units on a scale Standard Deviation 21.55	1.37 units on a scale Standard Deviation 17.00
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint Week 36 Day 246	-5.09 units on a scale Standard Deviation 21.32	1.52 units on a scale Standard Deviation 18.52

Adverse Events

IPILIMUMAB 10 MG/KG

Serious events: 257 serious events

Other events: 441 other events

Deaths: 173 deaths

PLACEBO

Serious events: 128 serious events

Other events: 382 other events

Deaths: 223 deaths

Serious adverse events

Measure	IPILIMUMAB 10 MG/KG n=471 participants at risk	PLACEBO n=474 participants at risk
Gastrointestinal disorders Enteritis	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Blood and lymphatic system disorders Lymphadenopathy	1.1% 5/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.63% 3/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Blood and lymphatic system disorders Lymphoid tissue hyperplasia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Blood and lymphatic system disorders Thrombocytopenia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Acute coronary syndrome	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Atrial fibrillation	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Atrial flutter	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Atrial tachycardia	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Bifascicular block	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Cardiac arrest	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Cardiac failure	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Cardiopulmonary failure	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Coronary artery disease	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Silent myocardial infarction	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Cardiac disorders Tachycardia	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Ear and labyrinth disorders Deafness unilateral	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Ear and labyrinth disorders Hypoacusis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Adrenal insufficiency	0.85% 4/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Adrenocorticotropic hormone deficiency	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Autoimmune thyroiditis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Basedow's disease	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Endocrine disorder	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Hyperadrenocorticism	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Hyperthyroidism	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Hypophysitis	7.9% 37/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Hypopituitarism	2.1% 10/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Hypothyroidism	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Lymphocytic hypophysitis	1.1% 5/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Thyroiditis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Eye disorders Autoimmune uveitis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Eye disorders Episcleritis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Eye disorders Ulcerative keratitis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Eye disorders Uveitis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Abdominal hernia	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Abdominal pain	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Abdominal pain lower	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Anal fissure	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Autoimmune colitis	0.85% 4/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Colitis	10.8% 51/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Colitis ulcerative	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Constipation	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Diarrhoea	7.6% 36/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	1.3% 6/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Duodenal ulcer	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Dysphagia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Enterocolitis haemorrhagic	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Gastric haemorrhage	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Gastritis	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Haemorrhoids	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Inguinal hernia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Intestinal perforation	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Nausea	0.85% 4/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Oesophageal haemorrhage	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Pancreatitis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Pancreatitis acute	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Rectal haemorrhage	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Umbilical hernia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Vomiting	1.7% 8/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Adverse event	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Asthenia	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Chest pain	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Disease progression	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.84% 4/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Disease recurrence	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.63% 3/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Fatigue	1.1% 5/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Influenza like illness	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Multiple organ dysfunction syndrome	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Pyrexia	3.8% 18/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Retention cyst	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Sudden death	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Hepatobiliary disorders Autoimmune hepatitis	2.5% 12/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Hepatobiliary disorders Cholecystitis	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Hepatobiliary disorders Hepatitis	0.85% 4/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Hepatobiliary disorders Hepatocellular injury	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Hepatobiliary disorders Hepatotoxicity	1.1% 5/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Hepatobiliary disorders Hyperbilirubinaemia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Immune system disorders Anaphylactoid reaction	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Immune system disorders Autoimmune disorder	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Immune system disorders Drug hypersensitivity	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Immune system disorders Hypersensitivity	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Immune system disorders Sarcoidosis	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Appendicitis	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Appendicitis perforated	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.63% 3/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Bacteraemia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Bacterial infection	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Beta haemolytic streptococcal infection	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Bronchitis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Cellulitis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.84% 4/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Cystitis	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Diarrhoea infectious	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Endocarditis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Erysipelas	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	1.5% 7/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations External ear cellulitis	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Gastroenteritis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Gastroenteritis viral	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Gastrointestinal infection	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Groin infection	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations H1N1 influenza	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Herpes ophthalmic	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Herpes zoster	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Infection	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Laryngitis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Localised infection	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Lung infection	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Meningitis	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Meningitis aseptic	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Meningitis bacterial	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Neuroborreliosis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Osteomyelitis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Otitis externa	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Perirectal abscess	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Pneumonia	0.85% 4/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Post procedural infection	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Sepsis	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Septic embolus	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Skin infection	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Staphylococcal infection	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Tooth infection	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Urinary tract infection	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Viral infection	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Wound infection	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Injury, poisoning and procedural complications Infusion related reaction	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Injury, poisoning and procedural complications Post procedural complication	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Injury, poisoning and procedural complications Radius fracture	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Injury, poisoning and procedural complications Respiratory tract procedural complication	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Injury, poisoning and procedural complications Seroma	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Alanine aminotransferase increased	3.6% 17/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Aspartate aminotransferase increased	3.2% 15/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Blood corticotrophin decreased	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Blood creatinine increased	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Ejection fraction decreased	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Gamma-glutamyltransferase increased	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Influenza A virus test positive	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Lipase increased	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Liver function test increased	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Lymph nodes scan abnormal	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Thyroid function test abnormal	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Transaminases increased	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Weight decreased	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Metabolism and nutrition disorders Dehydration	0.85% 4/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Metabolism and nutrition disorders Hyperglycaemia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Metabolism and nutrition disorders Hypoglycaemia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Metabolism and nutrition disorders Hypokalaemia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Metabolism and nutrition disorders Hyponatraemia	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Arthralgia	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Arthritis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Neck mass	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.63% 3/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	2.5% 12/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system melanoma	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endobronchial lipoma	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	1.9% 9/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.63% 3/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.85% 4/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	1.3% 6/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma recurrent	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	1.5% 7/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to adrenals	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to skin	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	2.3% 11/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncocytoma	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage 0	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancy	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	1.3% 6/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.84% 4/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Ataxia	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Autoimmune neuropathy	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Axonal neuropathy	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Carotid artery stenosis	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Cerebral thrombosis	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Cranial nerve disorder	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Guillain-Barre syndrome	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Haemorrhage intracranial	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Headache	1.3% 6/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Meningoradiculitis	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Neuropathy peripheral	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Peripheral motor neuropathy	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Peripheral sensory neuropathy	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Polyneuropathy	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Presyncope	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Seizure	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Spinal cord compression	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Syncope	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Trigeminal nerve disorder	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Psychiatric disorders Confusional state	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Psychiatric disorders Depression	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Psychiatric disorders Mental status changes	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Psychiatric disorders Substance-induced psychotic disorder	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Renal and urinary disorders Cystitis haemorrhagic	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Renal and urinary disorders Hydronephrosis	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Renal and urinary disorders Renal failure	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Renal and urinary disorders Urinary tract obstruction	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Reproductive system and breast disorders Ovarian cyst	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Eosinophilic pneumonia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.64% 3/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Pulmonary sarcoidosis	0.42% 2/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Angioedema	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Drug eruption	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Pruritus	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Rash	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Rash maculo-papular	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Vascular disorders Circulatory collapse	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Vascular disorders Haematoma	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Vascular disorders Hypotension	0.85% 4/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.00% 0/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Vascular disorders Lymphoedema	0.21% 1/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Vascular disorders Withdrawal hypertension	0.00% 0/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.21% 1/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)

Other adverse events

Measure	IPILIMUMAB 10 MG/KG n=471 participants at risk	PLACEBO n=474 participants at risk
Endocrine disorders Hypophysitis	11.9% 56/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	0.42% 2/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Endocrine disorders Hypothyroidism	10.0% 47/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	1.5% 7/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Abdominal pain	13.6% 64/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	9.3% 44/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Colitis	9.1% 43/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	1.1% 5/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Constipation	6.6% 31/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	6.3% 30/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Diarrhoea	48.6% 229/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	29.7% 141/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Nausea	24.8% 117/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	17.3% 82/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Gastrointestinal disorders Vomiting	13.0% 61/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	5.7% 27/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Asthenia	6.2% 29/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	8.0% 38/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Fatigue	39.9% 188/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	30.2% 143/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Influenza like illness	7.4% 35/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	6.3% 30/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Oedema peripheral	4.5% 21/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	5.7% 27/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
General disorders Pyrexia	15.5% 73/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	4.6% 22/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Infections and infestations Nasopharyngitis	4.5% 21/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	6.5% 31/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Alanine aminotransferase increased	20.2% 95/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	5.5% 26/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Aspartate aminotransferase increased	15.3% 72/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	5.5% 26/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Blood lactate dehydrogenase increased	7.0% 33/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	2.5% 12/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Blood testosterone decreased	6.2% 29/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	1.7% 8/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Lipase increased	8.9% 42/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	6.3% 30/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Weight decreased	31.6% 149/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	8.9% 42/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Investigations Weight increased	15.1% 71/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	24.1% 114/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Metabolism and nutrition disorders Decreased appetite	13.8% 65/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	3.4% 16/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Arthralgia	7.2% 34/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	9.5% 45/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Back pain	6.2% 29/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	8.6% 41/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.4% 16/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	5.5% 26/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Myalgia	4.5% 21/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	5.1% 24/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Musculoskeletal and connective tissue disorders Pain in extremity	4.5% 21/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	7.6% 36/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Dizziness	6.2% 29/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	3.8% 18/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Nervous system disorders Headache	31.8% 150/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	17.9% 85/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Psychiatric disorders Anxiety	4.5% 21/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	5.3% 25/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Psychiatric disorders Insomnia	9.6% 45/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	4.4% 21/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Cough	14.4% 68/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	10.1% 48/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.6% 31/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	3.4% 16/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Dermatitis acneiform	5.5% 26/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	1.3% 6/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Pruritus	43.1% 203/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	14.8% 70/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
Skin and subcutaneous tissue disorders Rash	39.5% 186/471 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)	16.9% 80/474 • Day 1 up to 70 days after last dose. Up to 10 years. Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER