History of Changes for Study: NCT02935634

A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer (FRACTION-GC)

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Study Record Versions

Version	Submitted Date	Changes
1	October 14, 2016	None (earliest Version on record)
2	October 25, 2016	References, Contacts/Locations, Conditions, Study Status and Study Identification
3	November 30, 2016	Recruitment Status, Study Status and Contacts/Locations
4	December 6, 2016	Contacts/Locations and Study Status
5	December 23, 2016	Contacts/Locations and Study Status
6	January 19, 2017	Study Status
7	January 23, 2017	Contacts/Locations and Study Status
8	February 16, 2017	Contacts/Locations and Study Status
9	March 3, 2017	Contacts/Locations and Study Status
10	March 29, 2017	Contacts/Locations, Study Status, Oversight and References
11	April 17, 2017	Contacts/Locations, Study Status and References
12	May 15, 2017	Contacts/Locations, Study Status and References
13	May 30, 2017	Contacts/Locations, Study Design and Study Status
14	June 30, 2017	Contacts/Locations and Study Status
15	July 18, 2017	Contacts/Locations and Study Status
16	July 31, 2017	Contacts/Locations and Study Status
17	August 15, 2017	Contacts/Locations and Study Status
18	August 30, 2017	Contacts/Locations and Study Status
19	September 1, 2017	Arms and Interventions, Contacts/Locations and Study Status
20	September 15, 2017	Study Status and Contacts/Locations
21	October 4, 2017	Study Status and Contacts/Locations
22	October 17, 2017	Contacts/Locations and Study Status
23	January 31, 2018	Contacts/Locations, Arms and Interventions, Outcome Measures and Study Status
24	February 22, 2018	Contacts/Locations and Study Status
25	March 12, 2018	Study Status and Contacts/Locations
26	April 9, 2018	Contacts/Locations and Study Status
27	May 7, 2018	Contacts/Locations and Study Status
28	October 2, 2018	Contacts/Locations, References and Study Status
29	November 27, 2018	Contacts/Locations and Study Status
30	January 30, 2019	Contacts/Locations and Study Status
31	May 28, 2019	Contacts/Locations and Study Status
32	September 19, 2019	Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures, Eligibility and Study Design
33	October 24, 2019	Arms and Interventions, Study Status and Sponsor/Collaborators
34	December 5, 2019	Contacts/Locations and Study Status
35	April 24, 2020	Contacts/Locations and Study Status
36	May 20, 2020	Contacts/Locations and Study Status
37	June 9, 2020	Study Status
38	June 15, 2020	Contacts/Locations and Study Status
39	August 24, 2020	Contacts/Locations and Study Status
40	July 14, 2021	Recruitment Status, Contacts/Locations, Study Status, Arms and Interventions and Study Design
41	January 20, 2022	Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Outcome Measures, References, Study Design, Study Description and Study Identification
42	March 17, 2022	Study Status
43	April 13, 2022	Contacts/Locations and Study Status
44	May 5, 2022	Study Status and Contacts/Locations
45	August 18, 2022	Contacts/Locations and Study Status
46	November 30, 2022	Study Status and Contacts/Locations
47	May 9, 2023	Recruitment Status, Study Status, Outcome Measures, Document Section, Results and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CA018-003
Brief Title:	A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer (FRACTION-GC)
Official Title:	A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer (FRACTION-Gastric Cancer)
Secondary IDs:	2016-002807-24 [EudraCT Number]

Study Status


Record Verification:	May 2023
Overall Status:	Completed
Study Start:	November 29, 2016
Primary Completion:	May 11, 2022 [Actual]
Study Completion:	May 11, 2022 [Actual]

First Submitted:	October 14, 2016
First Submitted that Met QC Criteria:	October 14, 2016
First Posted:	October 17, 2016 [Estimate]

Results First Submitted:	May 9, 2023
Results First Submitted that Met QC Criteria:	May 9, 2023
Results First Posted:	June 9, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	May 9, 2023
Last Update Posted:	June 9, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Bristol-Myers Squibb
Responsible Party:	Sponsor
Collaborators:	Clovis Oncology, Inc.

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


Brief Summary:	The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of Nivolumab in combination with Ipilimumab or other treatment therapies in participants with advanced gastric cancer.
Detailed Description:

Conditions


Conditions:	Advanced Gastric Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	6
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	190 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: Nivolumab + Ipilimumab	Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Biological: Ipilimumab Specified dose on specified days Other Names: Yervoy BMS-734016
Experimental: Nivolumab + Relatlimab	Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Biological: Relatlimab Specified dose on specified days Other Names: BMS-986016
Experimental: Nivolumab + BMS-986205	Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Biological: BMS-986205 Specified dose on specified days
Experimental: Nivolumab + Rucaparib	Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Drug: Rucaparib Specified dose on specified days Other Names: Rubraca
Experimental: Ipilimumab + Rucaparib	Biological: Ipilimumab Specified dose on specified days Other Names: Yervoy BMS-734016 Drug: Rucaparib Specified dose on specified days Other Names: Rubraca
Experimental: Nivolumab + Ipilimumab + Rucaparib	Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Biological: Ipilimumab Specified dose on specified days Other Names: Yervoy BMS-734016 Drug: Rucaparib Specified dose on specified days Other Names: Rubraca

Outcome Measures

[See Results Section.]


Primary Outcome Measures:
1.	Objective Response Rate (ORR) by Investigator [ Time Frame: From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months) ] ORR is the percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.
2.	Median Duration of Response (DOR) [ Time Frame: From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months) ] Duration of Response (DOR) is the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method.
3.	Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks [ Time Frame: 24 weeks after first dose ] The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula.
Secondary Outcome Measures:
1.	Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death [ Time Frame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months) ] An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
2.	Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests [ Time Frame: From first dose to 100 days after last dose of study therapy (approximately 30 months) ] The number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
3.	Number of Participants With Laboratory Abnormalities in Specific Liver Tests [ Time Frame: From first dose to 100 days after last dose of study therapy (approximately 30 months) ] The number of participants with laboratory abnormalities in specific liver tests based on US conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 At least 1 lesion with measurable disease Exclusion Criteria: HER2-positive tumor and previously untreated with trastuzumab Suspected, known or progressive central nervous system metastases Other active malignancy requiring concurrent intervention Active, known or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply

Contacts/Locations


Study Officials:	Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Locations:	United States, Arizona
	Mayo Clinic Arizona Phoenix, Arizona, United States, 85054
	United States, California
	Local Institution - 0020 Duarte, California, United States, 91010-3000
	United States, Colorado
	University Of Colorado Aurora, Colorado, United States, 80045
	United States, Connecticut
	Local Institution - 0032 New Haven, Connecticut, United States, 06520
	United States, District of Columbia
	Local Institution - 0036 Washington, District of Columbia, United States, 20007
	United States, Florida
	UF Health Medical Oncology - Davis Cancer Pavilion Gainesville, Florida, United States, 32610
	Local Institution - 0038 Jacksonville, Florida, United States, 32224
	United States, Maryland
	Local Institution - 0006 Baltimore, Maryland, United States, 21224
	United States, Minnesota
	Local Institution - 0017 Rochester, Minnesota, United States, 55905
	United States, Missouri
	Local Institution - 0003 Saint Louis, Missouri, United States, 63110
	United States, New Jersey
	Local Institution - 0001 Hackensack, New Jersey, United States, 07601
	United States, New York
	Local Institution - 0007 New York, New York, United States, 10065
	United States, Oregon
	Local Institution - 0002 Portland, Oregon, United States, 97225
	United States, Pennsylvania
	Local Institution - 0005 Philadelphia, Pennsylvania, United States, 19111
	UPMC Pittsburgh, Pennsylvania, United States, 15232
	United States, Washington
	Local Institution - 0004 Seattle, Washington, United States, 98109
	Australia
	Local Institution Randwick, Australia, 2031
	Australia, New South Wales
	Local Institution - 0035 Westmead, New South Wales, Australia, 2145
	Australia, Victoria
	Local Institution - 0033 Heidelberg, Victoria, Australia, 3084
	Canada, Alberta
	Local Institution Edmonton, Alberta, Canada, T6G 1Z2
	Canada, British Columbia
	Local Institution Vancouver, British Columbia, Canada, V5Z 4E6
	Canada, Ontario
	Local Institution Ottawa, Ontario, Canada, K1H 8L6
	Local Institution - 0021 Toronto, Ontario, Canada, M5G 2M9
	Local Institution - 0025 Toronto,, Ontario, Canada, M4N 3M5
	Germany
	Local Institution - 0039 Heidelberg, Germany, 69120
	Local Institution - 0043 Leipzig, Germany, 04103
	Israel
	Local Institution Ramat Gan, Israel, 52621
	Local Institution Tel Aviv, Israel, 64239
	Italy
	IRCCS Istituto Nazionale Tumori Milano Milano, Italy, 20133
	Italy, Lombardia
	Local Institution - 0014 Milan, Lombardia, Italy, 20141
	Netherlands
	Local Institution Amsterdam, Netherlands, 1081 HV
	Local Institution Utrecht, Netherlands, 3584 CX
	Singapore
	Local Institution - 0050 Singapore, Singapore, 169610
	Switzerland
	Local Institution - 0042 Zuerich, Switzerland, 8091
	Switzerland, Graubünden (de)
	Local Institution - 0041 Chur, Graubünden (de), Switzerland, 7000

IPDSharing


Plan to Share IPD:

References


Citations:
Links:	URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html Description: BMS Clinical Trial Information
	URL: https://www.bmsstudyconnect.com/s/US/English/USenHome Description: BMS Clinical Trial Patient Recruiting
	URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html Description: Investigator Inquiry Form
	URL: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm Description: FDA Safety Alerts and Recalls
Available IPD/Information:

Document Section


	Study Protocol and Statistical Analysis Plan Document Date: August 13, 2021 Uploaded: 05/09/2023 13:23 File Name: Prot_SAP_000.pdf

Participant Flow

Recruitment Details

Pre-assignment Details

Of the 190 participants that were randomized, 104 were initially randomized to Track 1 and 86 were initially randomized to Track 2. The 93 participants that started treatment in Track 2 include the total number of participants that received treatment in each arm which incorporates the 20 participants from Track 1 or 2 that were re-randomized to receive a different treatment combination in Track 2.

Arm/Group Title

Nivolumab + Ipilimumab

Nivolumab + BMS-986016

Nivolumab + BMS-986205

Nivolumab + Rucaparib

Ipilimumab + Rucaparib

Nivolumab + Ipilimumab + Rucaparib

Arm/Group Description

Participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.

Participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.

Participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.

Participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.

Participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.

Participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.

Period Title: Randomization

Started

Randomized to Track 1

Randomized to Track 2

Completed

Not Completed

Reason Not Completed

Participant withdrew consent

Death

Other reasons

Period Title: Treatment: Track 1

Started^[1]

Re-Randomized to Track 2

Completed

Not Completed

Reason Not Completed

Disease progression

Adverse event unrelated to study drug

Lost to Follow-up

Study drug toxicity

Participant request to discontinue treatment

Participant withdrew consent

Other reasons

[1]	Treatment naive participants

Period Title: Treatment: Track 2

Started^[1]

No Pre-Randomization

Re-Randomized From Track 1 Nivolumab + Relatlimab

Re-Randomized From Track 1 Nivolumab + Ipilimumab

Re-Randomized From Track 2 Nivolumab + Relatlimab

Re-Randomized From Track 2 Nivolumab + BMS986205

Previously Un-Treated But Re-Randomized

Re-Randomized From Track 2 Nivolumab + Ipilimumab

Completed

Not Completed

Reason Not Completed

Disease progression

Adverse event unrelated to study drug

Study drug toxicity

Participant request to discontinue treatment

Participant withdrew consent

[1]	Treatment experienced participants

Baseline Characteristics

Arm/Group Title

Track 1: Nivolumab + Ipilimumab

Track 1: Nivolumab + BMS-986016

Track 1: Nivolumab + BMS-986205

Track 1: Nivolumab + Rucaparib

Track 1: Ipilimumab + Rucaparib

Track 1: Nivolumab + Ipilimumab + Rucaparib

Track 2: Nivolumab + Ipilimumab

Track 2: Nivolumab + BMS-986016

Track 2: Nivolumab + BMS-986205

Track 2: Nivolumab + Rucaparib

Track 2: Ipilimumab + Rucaparib

Track 2: Nivolumab + Ipilimumab + Rucaparib

Total

Arm/Group Description

Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.

Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.

Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.

Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.

Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.

Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.

Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.

Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.

Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.

Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.

Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.

Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.

Total of all reporting groups

Overall Number of Baseline Participants

190

Baseline Analysis Population Description

[Not Specified]

Age, Continuous

Mean (Standard Deviation)
Unit of measure: Years

Number Analyzed

23 Participants

22 Participants

38 Participants

7 Participants

8 Participants

6 Participants

19 Participants

32 Participants

24 Participants

5 Participants

2 Participants

4 Participants

190 Participants

62.0(11.0)

58.1(12.6)

60.6(12.9)

58.1(10.4)

57.4(13.9)

59.5(6.7)

55.9(12.0)

61.8(11.8)

64.2(9.2)

58.0(16.2)

57.0(2.8)

53.0(16.4)

60.1(11.8)

Sex: Female, Male

Measure Type: Count of Participants
Unit of measure: Participants

Number Analyzed

23 Participants

22 Participants

38 Participants

7 Participants

8 Participants

6 Participants

19 Participants

32 Participants

24 Participants

5 Participants

2 Participants

4 Participants

190 Participants

Female

21.74%

18.18%

36.84%

50%

33.33%

10.53%

21.88%

37.5%

20%

25.26%

Male

78.26%

81.82%

63.16%

100%

50%

66.67%

89.47%

78.12%

62.5%

80%

100%

142

74.74%

Ethnicity (NIH/OMB)

Measure Type: Count of Participants
Unit of measure: Participants

Number Analyzed

23 Participants

22 Participants

38 Participants

7 Participants

8 Participants

6 Participants

19 Participants

32 Participants

24 Participants

5 Participants

2 Participants

4 Participants

190 Participants

Hispanic or Latino

4.35%

2.63%

5.26%

4.17%

2.11%

Not Hispanic or Latino

56.52%

77.27%

44.74%

28.57%

25%

66.67%

73.68%

78.12%

70.83%

60%

100%

50%

118

62.11%

Unknown or Not Reported

39.13%

22.73%

52.63%

71.43%

75%

33.33%

21.05%

21.88%

25%

40%

50%

35.79%

Race/Ethnicity, Customized^[1]

Measure Type: Count of Participants
Unit of measure: Participants

Number Analyzed

23 Participants

22 Participants

38 Participants

7 Participants

8 Participants

6 Participants

19 Participants

32 Participants

24 Participants

5 Participants

2 Participants

4 Participants

190 Participants

White

95.65%

86.36%

84.21%

100%

87.5%

100%

68.42%

90.62%

79.17%

80%

50%

75%

162

85.26%

Black or African American

2.63%

12.5%

6.25%

12.5%

50%

25%

4.74%

Asian

4.35%

9.09%

2.63%

10.53%

3.12%

8.33%

4.74%

American Indian or Alaska Native

2.63%

0.53%

Native Hawaiian or Other Pacific Islander

5.26%

0.53%

Other

4.55%

5.26%

10.53%

20%

3.16%

Not reported

2.63%

5.26%

1.05%

[1]	Measure Description: Race

Outcome Measures

1. Primary Outcome:

Title

Objective Response Rate (ORR) by Investigator

Description

ORR is the percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.

Time Frame

From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)

Outcome Measure Data

Analysis Population Description

All treated participants


Arm/Group Title	Track 1: Nivolumab + Ipilimumab	Track 1: Nivolumab + BMS-986016	Track 1: Nivolumab + BMS-986205	Track 1: Nivolumab + Rucaparib	Track 1: Ipilimumab + Rucaparib	Track 1: Nivolumab + Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab	Track 2: Nivolumab + BMS-986016	Track 2: Nivolumab + BMS-986205	Track 2: Nivolumab + Rucaparib	Track 2: Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab + Rucaparib
Arm/Group Description	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
Overall Number of Participants Analyzed	23	20	38	7	8	6	23	36	22	6	2	4
Number (95% Confidence Interval) Unit of Measure: Percent of participants	4.3(0.1 to 21.9)	5.0(0.1 to 24.9)	13.2(4.4 to 28.1)	0(0.0 to 41.0)	0(0.0 to 36.9)	16.7(0.4 to 64.1)	8.7(1.1 to 28.0)	5.6(0.7 to 18.7)	0(0.0 to 15.4)	0(0.0 to 45.9)	0(0.0 to 84.2)	0(0.0 to 60.2)

2. Primary Outcome:

Title

Median Duration of Response (DOR)

Description

Duration of Response (DOR) is the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method.

Time Frame

From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months)

Outcome Measure Data

Analysis Population Description

All treated participants with a complete response (CR) or partial response (PR)


Arm/Group Title	Track 1: Nivolumab + Ipilimumab	Track 1: Nivolumab + BMS-986016	Track 1: Nivolumab + BMS-986205	Track 1: Nivolumab + Rucaparib	Track 1: Ipilimumab + Rucaparib	Track 1: Nivolumab + Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab	Track 2: Nivolumab + BMS-986016	Track 2: Nivolumab + BMS-986205	Track 2: Nivolumab + Rucaparib	Track 2: Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab + Rucaparib
Arm/Group Description	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
Overall Number of Participants Analyzed	1	1	5	0	0	1	2	2	0	0	0	0
Median (Full Range) Unit of Measure: Weeks	156.0(156.0 to 156.0)	NA(113.4 to 113.4)^[1]	NA(37.3 to 144.0)^[1]			NA(0.1 to 0.1)^[1]	14.71(0.1 to 14.71)	16.86(8.1 to 25.6)

[1]	NA Explanation: Unable to calculate DOR due to insufficient number of participants who responded

3. Primary Outcome:

Title

Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks

Description

The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula.

Time Frame

24 weeks after first dose

Outcome Measure Data

Analysis Population Description

All treated participants


Arm/Group Title	Track 1: Nivolumab + Ipilimumab	Track 1: Nivolumab + BMS-986016	Track 1: Nivolumab + BMS-986205	Track 1: Nivolumab + Rucaparib	Track 1: Ipilimumab + Rucaparib	Track 1: Nivolumab + Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab	Track 2: Nivolumab + BMS-986016	Track 2: Nivolumab + BMS-986205	Track 2: Nivolumab + Rucaparib	Track 2: Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab + Rucaparib
Arm/Group Description	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
Overall Number of Participants Analyzed	23	20	38	7	8	6	23	36	22	6	2	4
Number (95% Confidence Interval) Unit of Measure: Proportion of participants	NA(NA to NA)^[1]	NA(NA to NA)^[1]	0.240(0.114 to 0.393)	NA(NA to NA)^[1]	NA(NA to NA)^[1]	NA(NA to NA)^[1]	NA(NA to NA)^[1]	0.170(0.063 to 0.322)	NA(NA to NA)^[1]	NA(NA to NA)^[1]	NA(NA to NA)^[1]	NA(NA to NA)^[1]

[1]	NA Explanation: Insufficient number of participants with events

4. Secondary Outcome:

Title

Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death

Description

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.

Time Frame

From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months)

Outcome Measure Data

Analysis Population Description

All treated participants


Arm/Group Title	Track 1: Nivolumab + Ipilimumab	Track 1: Nivolumab + BMS-986016	Track 1: Nivolumab + BMS-986205	Track 1: Nivolumab + Rucaparib	Track 1: Ipilimumab + Rucaparib	Track 1: Nivolumab + Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab	Track 2: Nivolumab + BMS-986016	Track 2: Nivolumab + BMS-986205	Track 2: Nivolumab + Rucaparib	Track 2: Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab + Rucaparib
Arm/Group Description	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
Overall Number of Participants Analyzed	23	20	38	7	8	6	23	36	22	6	2	4
Measure Type: Number Unit of Measure: Participants
Adverse Events (AEs)	23 100%	20 100%	38 100%	7 100%	8 100%	6 100%	23 100%	36 100%	22 100%	6 100%	2 100%	4 100%
Serious Adverse Events (SAEs)	19 82.6%	15 75%	24 63.2%	5 71.4%	6 75%	4 66.7%	17 73.9%	24 66.7%	12 54.5%	4 66.7%	2 100%	3 75%
AEs Leading to Discontinuation	9 39.1%	7 35%	11 28.9%	3 42.9%	4 50%	4 66.7%	10 43.5%	8 22.2%	2 9.1%	0 0%	1 50%	0 0%
Death	19 82.6%	15 75%	26 68.4%	7 100%	5 62.5%	4 66.7%	19 82.6%	26 72.2%	13 59.1%	3 50%	2 100%	3 75%

5. Secondary Outcome:

Title

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

Description

The number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.

Time Frame

From first dose to 100 days after last dose of study therapy (approximately 30 months)

Outcome Measure Data

Analysis Population Description

All treated participants with at least one on-treatment TSH measurement


Arm/Group Title	Track 1: Nivolumab + Ipilimumab	Track 1: Nivolumab + BMS-986016	Track 1: Nivolumab + BMS-986205	Track 1: Nivolumab + Rucaparib	Track 1: Ipilimumab + Rucaparib	Track 1: Nivolumab + Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab	Track 2: Nivolumab + BMS-986016	Track 2: Nivolumab + BMS-986205	Track 2: Nivolumab + Rucaparib	Track 2: Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab + Rucaparib
Arm/Group Description	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
Overall Number of Participants Analyzed	18	16	26	6	3	3	22	27	18	5	1	3
Measure Type: Count of Participants Unit of Measure: Participants
TSH > ULN	4 22.2%	4 25%	6 23.1%	1 16.7%	1 33.3%	1 33.3%	11 50%	5 18.5%	5 27.8%	0 0%	1 100%	1 33.3%
TSH > ULN WITH TSH <= ULN AT BASELINE	3 16.7%	3 18.8%	4 15.4%	0 0%	1 33.3%	1 33.3%	6 27.3%	1 3.7%	4 22.2%	0 0%	1 100%	0 0%
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN	1 5.6%	2 12.5%	2 7.7%	0 0%	1 33.3%	1 33.3%	5 22.7%	2 7.4%	2 11.1%	0 0%	0 0%	1 33.3%
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN	1 5.6%	1 6.2%	1 3.8%	1 16.7%	0 0%	0 0%	3 13.6%	2 7.4%	0 0%	0 0%	0 0%	0 0%
TSH > ULN WITH FT3/FT4 TEST MISSING	2 11.1%	1 6.2%	3 11.5%	0 0%	0 0%	0 0%	3 13.6%	1 3.7%	3 16.7%	0 0%	1 100%	0 0%
TSH < LLN	1 5.6%	2 12.5%	5 19.2%	0 0%	0 0%	0 0%	4 18.2%	6 22.2%	0 0%	0 0%	0 0%	0 0%
TSH <LLN WITH TSH >= LLN AT BASELINE	0 0%	1 6.2%	3 11.5%	0 0%	0 0%	0 0%	3 13.6%	5 18.5%	0 0%	0 0%	0 0%	0 0%
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN	1 5.6%	0 0%	2 7.7%	0 0%	0 0%	0 0%	3 13.6%	2 7.4%	0 0%	0 0%	0 0%	0 0%
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN	0 0%	2 12.5%	1 3.8%	0 0%	0 0%	0 0%	1 4.5%	0 0%	0 0%	0 0%	0 0%	0 0%
TSH < LLN WITH FT3/FT4 TEST MISSING	0 0%	0 0%	2 7.7%	0 0%	0 0%	0 0%	0 0%	4 14.8%	0 0%	0 0%	0 0%	0 0%

6. Secondary Outcome:

Title

Number of Participants With Laboratory Abnormalities in Specific Liver Tests

Description

The number of participants with laboratory abnormalities in specific liver tests based on US conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal

Time Frame

From first dose to 100 days after last dose of study therapy (approximately 30 months)

Outcome Measure Data

Analysis Population Description

All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement


Arm/Group Title	Track 1: Nivolumab + Ipilimumab	Track 1: Nivolumab + BMS-986016	Track 1: Nivolumab + BMS-986205	Track 1: Nivolumab + Rucaparib	Track 1: Ipilimumab + Rucaparib	Track 1: Nivolumab + Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab	Track 2: Nivolumab + BMS-986016	Track 2: Nivolumab + BMS-986205	Track 2: Nivolumab + Rucaparib	Track 2: Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab + Rucaparib
Arm/Group Description	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
Overall Number of Participants Analyzed	19	20	33	6	8	4	22	32	22	6	2	3
Measure Type: Count of Participants Unit of Measure: Participants
ALT OR AST > 3XULN	6 31.6%	6 30%	5 15.2%	1 16.7%	2 25%	1 25%	6 27.3%	2 6.2%	2 9.1%	3 50%	1 50%	0 0%
ALT OR AST> 5XULN	3 15.8%	2 10%	3 9.1%	0 0%	1 12.5%	1 25%	4 18.2%	1 3.1%	0 0%	0 0%	1 50%	0 0%
ALT OR AST> 10XULN	2 10.5%	1 5%	2 6.1%	0 0%	0 0%	0 0%	3 13.6%	0 0%	0 0%	0 0%	1 50%	0 0%
ALT OR AST > 20XULN	0 0%	0 0%	1 3%	0 0%	0 0%	0 0%	1 4.5%	0 0%	0 0%	0 0%	0 0%	0 0%
TOTAL BILIRUBIN > 2XULN	2 10.5%	3 15%	0 0%	1 16.7%	1 12.5%	1 25%	3 13.6%	1 3.1%	3 13.6%	1 16.7%	0 0%	0 0%
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY	2 10.5%	2 10%	0 0%	1 16.7%	1 12.5%	1 25%	2 9.1%	0 0%	0 0%	1 16.7%	0 0%	0 0%
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS	2 10.5%	2 10%	0 0%	1 16.7%	1 12.5%	1 25%	2 9.1%	0 0%	0 0%	1 16.7%	0 0%	0 0%

Adverse Events


Time Frame	Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
Adverse Event Reporting Description	The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.

Arm/Group Title	Track 1: Nivolumab + Ipilimumab	Track 1: Nivolumab + BMS-986016	Track 1: Nivolumab + BMS-986205	Track 1: Nivolumab + Rucaparib	Track 1: Ipilimumab + Rucaparib	Track 1: Nivolumab + Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab	Track 2: Nivolumab + BMS-986016	Track 2: Nivolumab + BMS-986205	Track 2: Nivolumab + Rucaparib	Track 2: Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab + Rucaparib
Arm/Group Description	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
All-Cause Mortality
	Track 1: Nivolumab + Ipilimumab	Track 1: Nivolumab + BMS-986016	Track 1: Nivolumab + BMS-986205	Track 1: Nivolumab + Rucaparib	Track 1: Ipilimumab + Rucaparib	Track 1: Nivolumab + Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab	Track 2: Nivolumab + BMS-986016	Track 2: Nivolumab + BMS-986205	Track 2: Nivolumab + Rucaparib	Track 2: Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab + Rucaparib
	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)
Total	19 / 23 (82.61%)	15 / 23 (65.22%)	26 / 39 (66.67%)	7 / 7 (100%)	5 / 8 (62.5%)	4 / 6 (66.67%)	19 / 28 (67.86%)	26 / 41 (63.41%)	13 / 25 (52%)	3 / 6 (50%)	2 / 2 (100%)	3 / 4 (75%)
Serious Adverse Events
	Track 1: Nivolumab + Ipilimumab	Track 1: Nivolumab + BMS-986016	Track 1: Nivolumab + BMS-986205	Track 1: Nivolumab + Rucaparib	Track 1: Ipilimumab + Rucaparib	Track 1: Nivolumab + Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab	Track 2: Nivolumab + BMS-986016	Track 2: Nivolumab + BMS-986205	Track 2: Nivolumab + Rucaparib	Track 2: Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab + Rucaparib
	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)
Total	19 / 23 (82.61%)	15 / 20 (75%)	24 / 38 (63.16%)	5 / 7 (71.43%)	6 / 8 (75%)	4 / 6 (66.67%)	17 / 23 (73.91%)	24 / 36 (66.67%)	12 / 22 (54.55%)	4 / 6 (66.67%)	2 / 2 (100%)	3 / 4 (75%)
Blood and lymphatic system disorders
Anaemia ^{† A}	1 / 23 (4.35%)	3 / 20 (15%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Febrile neutropenia ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Cardiac disorders
Atrial fibrillation ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Supraventricular tachycardia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Endocrine disorders
Adrenal insufficiency ^{† A}	0 / 23 (0%)	1 / 20 (5%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Basedow's disease ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Lymphocytic hypophysitis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Secondary adrenocortical insufficiency ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Gastrointestinal disorders
Abdominal pain ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	3 / 36 (8.33%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Abdominal pain upper ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Ascites ^{† A}	0 / 23 (0%)	1 / 20 (5%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Colitis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Constipation ^{† A}	0 / 23 (0%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Diarrhoea ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Duodenal obstruction ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Dysphagia ^{† A}	1 / 23 (4.35%)	2 / 20 (10%)	4 / 38 (10.53%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Gastric haemorrhage ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Gastric perforation ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Haematemesis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Ileus ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Large intestinal obstruction ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Large intestine perforation ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Nausea ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Oesophageal perforation ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Oesophageal stenosis ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Small intestinal obstruction ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Upper gastrointestinal haemorrhage ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Vomiting ^{† A}	0 / 23 (0%)	2 / 20 (10%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
General disorders
Asthenia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Chest discomfort ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Death ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Fatigue ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
General physical health deterioration ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	2 / 7 (28.57%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Multiple organ dysfunction syndrome ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Non-cardiac chest pain ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pain ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Performance status decreased ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pyrexia ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	1 / 2 (50%)	0 / 4 (0%)
Sudden death ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Systemic inflammatory response syndrome ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hepatobiliary disorders
Autoimmune hepatitis ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Cholecystitis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hepatic failure ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hepatic haematoma ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hepatitis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Hyperbilirubinaemia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Portal vein thrombosis ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Infections and infestations
Atypical pneumonia ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Clostridium difficile infection ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Ophthalmic herpes zoster ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pneumocystis jirovecii pneumonia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pneumonia ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	1 / 2 (50%)	0 / 4 (0%)
Pneumonia viral ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Sepsis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Skin bacterial infection ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Streptococcal bacteraemia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Upper respiratory tract infection ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Urinary tract infection ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Vascular device infection ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Wound infection ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Injury, poisoning and procedural complications
Acetabulum fracture ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Fall ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Femur fracture ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Procedural pain ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Investigations
Aspartate aminotransferase increased ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Blood bilirubin increased ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Blood creatinine increased ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hepatic enzyme increased ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Neutrophil count decreased ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Weight decreased ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Metabolism and nutrition disorders
Dehydration ^{† A}	0 / 23 (0%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Failure to thrive ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hyperkalaemia ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hyponatraemia ^{† A}	1 / 23 (4.35%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Metabolic acidosis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Back pain ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Flank pain ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Intervertebral disc protrusion ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Muscular weakness ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Keratoacanthoma ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Malignant neoplasm progression ^{† A}	11 / 23 (47.83%)	6 / 20 (30%)	11 / 38 (28.95%)	0 / 7 (0%)	3 / 8 (37.5%)	0 / 6 (0%)	5 / 23 (21.74%)	9 / 36 (25%)	8 / 22 (36.36%)	2 / 6 (33.33%)	1 / 2 (50%)	2 / 4 (50%)
Metastases to central nervous system ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Tumour haemorrhage ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Tumour pain ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Tumour perforation ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Nervous system disorders
Brain oedema ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Cerebral infarction ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Cerebrovascular accident ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Encephalopathy ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Haemorrhage intracranial ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Seizure ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Syncope ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Transient ischaemic attack ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Product Issues
Device dislocation ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Psychiatric disorders
Delirium ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Renal and urinary disorders
Acute kidney injury ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Urinary tract obstruction ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Aspiration ^{† A}	3 / 23 (13.04%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Dyspnoea ^{† A}	0 / 23 (0%)	1 / 20 (5%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	2 / 22 (9.09%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Haemoptysis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hypoxia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pleural effusion ^{† A}	3 / 23 (13.04%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pneumothorax ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pulmonary embolism ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Respiratory failure ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Skin and subcutaneous tissue disorders
Decubitus ulcer ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Rash ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Vascular disorders
Embolism ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hypotension ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Superior vena cava stenosis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
†Indicates events were collected by systematic assessment. ATerm from vocabulary, 25.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Track 1: Nivolumab + Ipilimumab	Track 1: Nivolumab + BMS-986016	Track 1: Nivolumab + BMS-986205	Track 1: Nivolumab + Rucaparib	Track 1: Ipilimumab + Rucaparib	Track 1: Nivolumab + Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab	Track 2: Nivolumab + BMS-986016	Track 2: Nivolumab + BMS-986205	Track 2: Nivolumab + Rucaparib	Track 2: Ipilimumab + Rucaparib	Track 2: Nivolumab + Ipilimumab + Rucaparib
	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)
Total	21 / 23 (91.3%)	20 / 20 (100%)	38 / 38 (100%)	7 / 7 (100%)	8 / 8 (100%)	6 / 6 (100%)	23 / 23 (100%)	34 / 36 (94.44%)	21 / 22 (95.45%)	6 / 6 (100%)	2 / 2 (100%)	4 / 4 (100%)
Blood and lymphatic system disorders
Anaemia ^{† A}	6 / 23 (26.09%)	8 / 20 (40%)	12 / 38 (31.58%)	1 / 7 (14.29%)	3 / 8 (37.5%)	2 / 6 (33.33%)	7 / 23 (30.43%)	11 / 36 (30.56%)	7 / 22 (31.82%)	1 / 6 (16.67%)	0 / 2 (0%)	1 / 4 (25%)
Coagulopathy ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Leukocytosis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Lymphadenopathy ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Lymphopenia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Neutropenia ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	2 / 36 (5.56%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Cardiac disorders
Atrial fibrillation ^{† A}	2 / 23 (8.7%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Palpitations ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	1 / 6 (16.67%)	2 / 23 (8.7%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Sinus tachycardia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Tachycardia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Ear and labyrinth disorders
Cerumen impaction ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Vertigo ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	2 / 36 (5.56%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Endocrine disorders
Hyperthyroidism ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hypothyroidism ^{† A}	1 / 23 (4.35%)	3 / 20 (15%)	4 / 38 (10.53%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	3 / 23 (13.04%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Eye disorders
Vision blurred ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	1 / 23 (4.35%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Gastrointestinal disorders
Abdominal distension ^{† A}	2 / 23 (8.7%)	0 / 20 (0%)	3 / 38 (7.89%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Abdominal pain ^{† A}	7 / 23 (30.43%)	7 / 20 (35%)	11 / 38 (28.95%)	2 / 7 (28.57%)	1 / 8 (12.5%)	2 / 6 (33.33%)	7 / 23 (30.43%)	6 / 36 (16.67%)	1 / 22 (4.55%)	3 / 6 (50%)	0 / 2 (0%)	2 / 4 (50%)
Abdominal pain lower ^{† A}	0 / 23 (0%)	3 / 20 (15%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Abdominal pain upper ^{† A}	1 / 23 (4.35%)	4 / 20 (20%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	2 / 6 (33.33%)	1 / 23 (4.35%)	2 / 36 (5.56%)	3 / 22 (13.64%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Ascites ^{† A}	0 / 23 (0%)	1 / 20 (5%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Colitis ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Constipation ^{† A}	3 / 23 (13.04%)	5 / 20 (25%)	9 / 38 (23.68%)	2 / 7 (28.57%)	2 / 8 (25%)	2 / 6 (33.33%)	7 / 23 (30.43%)	6 / 36 (16.67%)	4 / 22 (18.18%)	2 / 6 (33.33%)	1 / 2 (50%)	1 / 4 (25%)
Diarrhoea ^{† A}	2 / 23 (8.7%)	5 / 20 (25%)	7 / 38 (18.42%)	4 / 7 (57.14%)	1 / 8 (12.5%)	2 / 6 (33.33%)	7 / 23 (30.43%)	7 / 36 (19.44%)	3 / 22 (13.64%)	2 / 6 (33.33%)	1 / 2 (50%)	1 / 4 (25%)
Dry mouth ^{† A}	1 / 23 (4.35%)	1 / 20 (5%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	2 / 23 (8.7%)	1 / 36 (2.78%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Dyspepsia ^{† A}	0 / 23 (0%)	2 / 20 (10%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Dysphagia ^{† A}	6 / 23 (26.09%)	3 / 20 (15%)	8 / 38 (21.05%)	3 / 7 (42.86%)	0 / 8 (0%)	2 / 6 (33.33%)	4 / 23 (17.39%)	5 / 36 (13.89%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Flatulence ^{† A}	1 / 23 (4.35%)	1 / 20 (5%)	3 / 38 (7.89%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	1 / 36 (2.78%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Gastrooesophageal reflux disease ^{† A}	0 / 23 (0%)	4 / 20 (20%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	2 / 22 (9.09%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Ileus ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Jejunal stenosis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Large intestinal obstruction ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Nausea ^{† A}	8 / 23 (34.78%)	10 / 20 (50%)	17 / 38 (44.74%)	4 / 7 (57.14%)	4 / 8 (50%)	2 / 6 (33.33%)	10 / 23 (43.48%)	9 / 36 (25%)	6 / 22 (27.27%)	4 / 6 (66.67%)	0 / 2 (0%)	2 / 4 (50%)
Oesophageal pain ^{† A}	0 / 23 (0%)	1 / 20 (5%)	1 / 38 (2.63%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Oesophageal stenosis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	2 / 7 (28.57%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Rectal haemorrhage ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Stomatitis ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Vomiting ^{† A}	7 / 23 (30.43%)	5 / 20 (25%)	7 / 38 (18.42%)	0 / 7 (0%)	1 / 8 (12.5%)	2 / 6 (33.33%)	7 / 23 (30.43%)	7 / 36 (19.44%)	1 / 22 (4.55%)	2 / 6 (33.33%)	0 / 2 (0%)	2 / 4 (50%)
General disorders
Asthenia ^{† A}	4 / 23 (17.39%)	3 / 20 (15%)	4 / 38 (10.53%)	0 / 7 (0%)	2 / 8 (25%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Chills ^{† A}	0 / 23 (0%)	1 / 20 (5%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	2 / 6 (33.33%)	1 / 2 (50%)	0 / 4 (0%)
Early satiety ^{† A}	0 / 23 (0%)	1 / 20 (5%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Fatigue ^{† A}	13 / 23 (56.52%)	11 / 20 (55%)	23 / 38 (60.53%)	2 / 7 (28.57%)	5 / 8 (62.5%)	2 / 6 (33.33%)	10 / 23 (43.48%)	22 / 36 (61.11%)	11 / 22 (50%)	5 / 6 (83.33%)	2 / 2 (100%)	2 / 4 (50%)
General physical health deterioration ^{† A}	2 / 23 (8.7%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Influenza like illness ^{† A}	1 / 23 (4.35%)	1 / 20 (5%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Malaise ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	2 / 36 (5.56%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Mucosal inflammation ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Non-cardiac chest pain ^{† A}	0 / 23 (0%)	0 / 20 (0%)	3 / 38 (7.89%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	1 / 36 (2.78%)	2 / 22 (9.09%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Oedema peripheral ^{† A}	3 / 23 (13.04%)	1 / 20 (5%)	3 / 38 (7.89%)	1 / 7 (14.29%)	1 / 8 (12.5%)	1 / 6 (16.67%)	1 / 23 (4.35%)	5 / 36 (13.89%)	4 / 22 (18.18%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Pain ^{† A}	1 / 23 (4.35%)	1 / 20 (5%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pyrexia ^{† A}	7 / 23 (30.43%)	3 / 20 (15%)	8 / 38 (21.05%)	1 / 7 (14.29%)	2 / 8 (25%)	0 / 6 (0%)	4 / 23 (17.39%)	5 / 36 (13.89%)	2 / 22 (9.09%)	2 / 6 (33.33%)	0 / 2 (0%)	1 / 4 (25%)
Hepatobiliary disorders
Autoimmune hepatitis ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Infections and infestations
Bronchitis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
COVID-19 ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Cellulitis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Clostridium difficile infection ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Genital herpes ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Lymph gland infection ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Paronychia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Pneumonia ^{† A}	1 / 23 (4.35%)	1 / 20 (5%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Sepsis ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Urinary tract infection ^{† A}	0 / 23 (0%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Injury, poisoning and procedural complications
Arthropod bite ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Contusion ^{† A}	1 / 23 (4.35%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Fall ^{† A}	0 / 23 (0%)	1 / 20 (5%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Infusion related reaction ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Investigations
Activated partial thromboplastin time prolonged ^{† A}	0 / 23 (0%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	2 / 36 (5.56%)	2 / 22 (9.09%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Alanine aminotransferase increased ^{† A}	0 / 23 (0%)	5 / 20 (25%)	7 / 38 (18.42%)	1 / 7 (14.29%)	3 / 8 (37.5%)	4 / 6 (66.67%)	5 / 23 (21.74%)	3 / 36 (8.33%)	2 / 22 (9.09%)	1 / 6 (16.67%)	1 / 2 (50%)	0 / 4 (0%)
Amylase increased ^{† A}	1 / 23 (4.35%)	3 / 20 (15%)	4 / 38 (10.53%)	1 / 7 (14.29%)	1 / 8 (12.5%)	0 / 6 (0%)	1 / 23 (4.35%)	1 / 36 (2.78%)	3 / 22 (13.64%)	1 / 6 (16.67%)	1 / 2 (50%)	0 / 4 (0%)
Aspartate aminotransferase increased ^{† A}	0 / 23 (0%)	5 / 20 (25%)	8 / 38 (21.05%)	2 / 7 (28.57%)	3 / 8 (37.5%)	4 / 6 (66.67%)	5 / 23 (21.74%)	3 / 36 (8.33%)	4 / 22 (18.18%)	1 / 6 (16.67%)	1 / 2 (50%)	1 / 4 (25%)
Blood alkaline phosphatase increased ^{† A}	3 / 23 (13.04%)	3 / 20 (15%)	5 / 38 (13.16%)	3 / 7 (42.86%)	1 / 8 (12.5%)	2 / 6 (33.33%)	6 / 23 (26.09%)	4 / 36 (11.11%)	4 / 22 (18.18%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Blood bilirubin increased ^{† A}	2 / 23 (8.7%)	6 / 20 (30%)	3 / 38 (7.89%)	2 / 7 (28.57%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	2 / 36 (5.56%)	3 / 22 (13.64%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Blood creatine increased ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	1 / 4 (25%)
Blood creatine phosphokinase increased ^{† A}	0 / 23 (0%)	2 / 20 (10%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Blood creatinine increased ^{† A}	0 / 23 (0%)	1 / 20 (5%)	3 / 38 (7.89%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	1 / 36 (2.78%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Blood pressure increased ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Blood urea increased ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
C-reactive protein increased ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	1 / 4 (25%)
Electrocardiogram QT prolonged ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Gamma-glutamyltransferase increased ^{† A}	4 / 23 (17.39%)	2 / 20 (10%)	2 / 38 (5.26%)	2 / 7 (28.57%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Glomerular filtration rate decreased ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
International normalised ratio increased ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	3 / 36 (8.33%)	2 / 22 (9.09%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Lipase increased ^{† A}	2 / 23 (8.7%)	3 / 20 (15%)	3 / 38 (7.89%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	1 / 36 (2.78%)	4 / 22 (18.18%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Lymph node palpable ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Lymphocyte count decreased ^{† A}	0 / 23 (0%)	1 / 20 (5%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	6 / 36 (16.67%)	3 / 22 (13.64%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Neutrophil count decreased ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	1 / 22 (4.55%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Platelet count decreased ^{† A}	0 / 23 (0%)	2 / 20 (10%)	2 / 38 (5.26%)	0 / 7 (0%)	1 / 8 (12.5%)	1 / 6 (16.67%)	0 / 23 (0%)	2 / 36 (5.56%)	3 / 22 (13.64%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Weight decreased ^{† A}	4 / 23 (17.39%)	2 / 20 (10%)	4 / 38 (10.53%)	2 / 7 (28.57%)	2 / 8 (25%)	0 / 6 (0%)	2 / 23 (8.7%)	2 / 36 (5.56%)	2 / 22 (9.09%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
White blood cell count decreased ^{† A}	0 / 23 (0%)	2 / 20 (10%)	1 / 38 (2.63%)	1 / 7 (14.29%)	1 / 8 (12.5%)	1 / 6 (16.67%)	0 / 23 (0%)	4 / 36 (11.11%)	2 / 22 (9.09%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Metabolism and nutrition disorders
Decreased appetite ^{† A}	10 / 23 (43.48%)	10 / 20 (50%)	9 / 38 (23.68%)	2 / 7 (28.57%)	2 / 8 (25%)	0 / 6 (0%)	7 / 23 (30.43%)	14 / 36 (38.89%)	8 / 22 (36.36%)	2 / 6 (33.33%)	1 / 2 (50%)	2 / 4 (50%)
Dehydration ^{† A}	0 / 23 (0%)	0 / 20 (0%)	3 / 38 (7.89%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	1 / 23 (4.35%)	2 / 36 (5.56%)	3 / 22 (13.64%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Hyperglycaemia ^{† A}	1 / 23 (4.35%)	2 / 20 (10%)	4 / 38 (10.53%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	7 / 36 (19.44%)	4 / 22 (18.18%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hyperkalaemia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hypermagnesaemia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hypoalbuminaemia ^{† A}	3 / 23 (13.04%)	5 / 20 (25%)	4 / 38 (10.53%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	5 / 36 (13.89%)	3 / 22 (13.64%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Hypocalcaemia ^{† A}	0 / 23 (0%)	2 / 20 (10%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	4 / 36 (11.11%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hypokalaemia ^{† A}	3 / 23 (13.04%)	3 / 20 (15%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	2 / 23 (8.7%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Hypomagnesaemia ^{† A}	2 / 23 (8.7%)	2 / 20 (10%)	3 / 38 (7.89%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	4 / 36 (11.11%)	1 / 22 (4.55%)	0 / 6 (0%)	1 / 2 (50%)	1 / 4 (25%)
Hyponatraemia ^{† A}	5 / 23 (21.74%)	5 / 20 (25%)	4 / 38 (10.53%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	4 / 36 (11.11%)	1 / 22 (4.55%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Hypophosphataemia ^{† A}	0 / 23 (0%)	3 / 20 (15%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	1 / 2 (50%)	1 / 4 (25%)
Iron deficiency ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia ^{† A}	2 / 23 (8.7%)	4 / 20 (20%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	5 / 23 (21.74%)	3 / 36 (8.33%)	2 / 22 (9.09%)	1 / 6 (16.67%)	0 / 2 (0%)	1 / 4 (25%)
Arthritis ^{† A}	0 / 23 (0%)	2 / 20 (10%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Back pain ^{† A}	2 / 23 (8.7%)	5 / 20 (25%)	3 / 38 (7.89%)	1 / 7 (14.29%)	1 / 8 (12.5%)	0 / 6 (0%)	3 / 23 (13.04%)	3 / 36 (8.33%)	3 / 22 (13.64%)	3 / 6 (50%)	0 / 2 (0%)	0 / 4 (0%)
Chondrocalcinosis pyrophosphate ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Muscle spasms ^{† A}	0 / 23 (0%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	2 / 36 (5.56%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Muscular weakness ^{† A}	0 / 23 (0%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	1 / 36 (2.78%)	1 / 22 (4.55%)	1 / 6 (16.67%)	0 / 2 (0%)	1 / 4 (25%)
Musculoskeletal chest pain ^{† A}	0 / 23 (0%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	1 / 6 (16.67%)	0 / 23 (0%)	1 / 36 (2.78%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Musculoskeletal pain ^{† A}	2 / 23 (8.7%)	1 / 20 (5%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Myalgia ^{† A}	1 / 23 (4.35%)	2 / 20 (10%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	2 / 36 (5.56%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	1 / 4 (25%)
Neck pain ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	3 / 36 (8.33%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pain in extremity ^{† A}	2 / 23 (8.7%)	2 / 20 (10%)	4 / 38 (10.53%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	2 / 23 (8.7%)	0 / 36 (0%)	1 / 22 (4.55%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Sacral pain ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Nervous system disorders
Disturbance in attention ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Dizziness ^{† A}	2 / 23 (8.7%)	1 / 20 (5%)	5 / 38 (13.16%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	5 / 23 (21.74%)	9 / 36 (25%)	4 / 22 (18.18%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Dysgeusia ^{† A}	0 / 23 (0%)	4 / 20 (20%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	1 / 36 (2.78%)	1 / 22 (4.55%)	0 / 6 (0%)	1 / 2 (50%)	1 / 4 (25%)
Headache ^{† A}	0 / 23 (0%)	2 / 20 (10%)	6 / 38 (15.79%)	0 / 7 (0%)	0 / 8 (0%)	2 / 6 (33.33%)	1 / 23 (4.35%)	5 / 36 (13.89%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Paraesthesia ^{† A}	0 / 23 (0%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Peripheral sensory neuropathy ^{† A}	0 / 23 (0%)	1 / 20 (5%)	3 / 38 (7.89%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	3 / 36 (8.33%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Polyneuropathy ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Restless legs syndrome ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Tremor ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Psychiatric disorders
Anxiety ^{† A}	0 / 23 (0%)	1 / 20 (5%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	0 / 36 (0%)	2 / 22 (9.09%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Confusional state ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	3 / 23 (13.04%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Depression ^{† A}	2 / 23 (8.7%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	3 / 36 (8.33%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Insomnia ^{† A}	0 / 23 (0%)	1 / 20 (5%)	3 / 38 (7.89%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	3 / 23 (13.04%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	1 / 2 (50%)	1 / 4 (25%)
Panic attack ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Restlessness ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Suicidal ideation ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Renal and urinary disorders
Dysuria ^{† A}	0 / 23 (0%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Proteinuria ^{† A}	0 / 23 (0%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Reproductive system and breast disorders
Ejaculation disorder ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Oedema genital ^{† A}	2 / 23 (8.7%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Cough ^{† A}	6 / 23 (26.09%)	4 / 20 (20%)	8 / 38 (21.05%)	1 / 7 (14.29%)	0 / 8 (0%)	1 / 6 (16.67%)	4 / 23 (17.39%)	7 / 36 (19.44%)	3 / 22 (13.64%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Dyspnoea ^{† A}	4 / 23 (17.39%)	2 / 20 (10%)	7 / 38 (18.42%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	5 / 23 (21.74%)	6 / 36 (16.67%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Dyspnoea exertional ^{† A}	2 / 23 (8.7%)	1 / 20 (5%)	1 / 38 (2.63%)	1 / 7 (14.29%)	0 / 8 (0%)	1 / 6 (16.67%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Hiccups ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Nasal congestion ^{† A}	2 / 23 (8.7%)	1 / 20 (5%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	2 / 23 (8.7%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	1 / 4 (25%)
Oropharyngeal pain ^{† A}	0 / 23 (0%)	1 / 20 (5%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pleural effusion ^{† A}	2 / 23 (8.7%)	0 / 20 (0%)	1 / 38 (2.63%)	1 / 7 (14.29%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Pneumonitis ^{† A}	0 / 23 (0%)	1 / 20 (5%)	1 / 38 (2.63%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	1 / 23 (4.35%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Productive cough ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	1 / 38 (2.63%)	1 / 7 (14.29%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Upper-airway cough syndrome ^{† A}	0 / 23 (0%)	0 / 20 (0%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	3 / 36 (8.33%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Skin and subcutaneous tissue disorders
Alopecia ^{† A}	0 / 23 (0%)	2 / 20 (10%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Dermatitis acneiform ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	1 / 23 (4.35%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Dry skin ^{† A}	0 / 23 (0%)	3 / 20 (15%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	2 / 23 (8.7%)	5 / 36 (13.89%)	1 / 22 (4.55%)	1 / 6 (16.67%)	0 / 2 (0%)	1 / 4 (25%)
Night sweats ^{† A}	0 / 23 (0%)	0 / 20 (0%)	2 / 38 (5.26%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Photosensitivity reaction ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
Pruritus ^{† A}	2 / 23 (8.7%)	1 / 20 (5%)	4 / 38 (10.53%)	0 / 7 (0%)	1 / 8 (12.5%)	2 / 6 (33.33%)	6 / 23 (26.09%)	4 / 36 (11.11%)	2 / 22 (9.09%)	0 / 6 (0%)	1 / 2 (50%)	1 / 4 (25%)
Rash ^{† A}	1 / 23 (4.35%)	2 / 20 (10%)	4 / 38 (10.53%)	0 / 7 (0%)	3 / 8 (37.5%)	0 / 6 (0%)	1 / 23 (4.35%)	1 / 36 (2.78%)	0 / 22 (0%)	2 / 6 (33.33%)	1 / 2 (50%)	0 / 4 (0%)
Rash maculo-papular ^{† A}	5 / 23 (21.74%)	1 / 20 (5%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	1 / 22 (4.55%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Rash papular ^{† A}	3 / 23 (13.04%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	1 / 36 (2.78%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Skin fissures ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	1 / 7 (14.29%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Vascular disorders
Deep vein thrombosis ^{† A}	1 / 23 (4.35%)	0 / 20 (0%)	1 / 38 (2.63%)	0 / 7 (0%)	1 / 8 (12.5%)	0 / 6 (0%)	1 / 23 (4.35%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Hypertension ^{† A}	1 / 23 (4.35%)	1 / 20 (5%)	3 / 38 (7.89%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	2 / 36 (5.56%)	0 / 22 (0%)	0 / 6 (0%)	1 / 2 (50%)	0 / 4 (0%)
Hypotension ^{† A}	1 / 23 (4.35%)	1 / 20 (5%)	2 / 38 (5.26%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	2 / 23 (8.7%)	2 / 36 (5.56%)	2 / 22 (9.09%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Jugular vein thrombosis ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	1 / 6 (16.67%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	0 / 6 (0%)	0 / 2 (0%)	0 / 4 (0%)
Orthostatic hypotension ^{† A}	0 / 23 (0%)	0 / 20 (0%)	0 / 38 (0%)	0 / 7 (0%)	0 / 8 (0%)	0 / 6 (0%)	0 / 23 (0%)	0 / 36 (0%)	0 / 22 (0%)	1 / 6 (16.67%)	0 / 2 (0%)	0 / 4 (0%)
†Indicates events were collected by systematic assessment. ATerm from vocabulary, 25.0

Limitations and Caveats


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Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact:
Name/Official Title:	Bristol-Myers Squibb Study Director
Organization:	Bristol-Myers Squibb
Phone:	Please Email
Email:	Clinical.Trials@bms.com