Trial Outcomes & Findings for Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure (NCT NCT03016325)

Last Updated: 2021-01-06

Results Overview

Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) \< 90 mm Hg (confirmed by a repeated value \< 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

329 participants

Primary outcome timeframe

From start of infusion up to 6 hours post end of infusion

Results posted on

2021-01-06

Participant Flow

Main study cohorts: 100 participants in Part I and 222 in Part II were assigned to treatment (322 randomized in total), of which 97 and 214, respectively, were treated (311 total treated). Reasons not treated (Part I): 3 other reasons. Reasons not treated (Part II): 2 no longer met study criteria; 1 adverse event (AE); 5 other reasons. Japanese-specific cohort: 18 participants were randomized and treated in Part II (Japan cohort)

Participant milestones

Participant milestones
Measure	Placebo - Part I Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)	BMS-986231 - Part I Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)	Placebo - Part II Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours	BMS-986231 6 µg/kg/Min - Part II BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Treatment Period STARTED	48	49	71	71	72	6	6	6
Treatment Period COMPLETED	48	48	70	71	70	6	6	6
Treatment Period NOT COMPLETED	0	1	1	0	2	0	0	0
32-Day Follow-Up Period STARTED	48	49	71	71	72	6	6	6
32-Day Follow-Up Period COMPLETED	44	47	62	63	64	6	5	6
32-Day Follow-Up Period NOT COMPLETED	4	2	9	8	8	0	1	0
182-Day Follow-Up Period STARTED	48	49	71	71	72	6	6	6
182-Day Follow-Up Period COMPLETED	44	45	60	58	60	1	2	1
182-Day Follow-Up Period NOT COMPLETED	4	4	11	13	12	5	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo - Part I Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)	BMS-986231 - Part I Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)	Placebo - Part II Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours	BMS-986231 6 µg/kg/Min - Part II BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Treatment Period Participant withdrew consent	0	1	0	0	0	0	0	0
Treatment Period Death	0	0	0	0	2	0	0	0
Treatment Period Participant refuses assessments	0	0	1	0	0	0	0	0
32-Day Follow-Up Period Death	2	0	5	6	3	0	0	0
32-Day Follow-Up Period Lost to Follow-up	1	0	1	1	0	0	0	0
32-Day Follow-Up Period Poor/non-compliance	1	0	0	1	1	0	0	0
32-Day Follow-Up Period Participant refused to visit	0	1	2	0	2	0	0	0
32-Day Follow-Up Period Participant withdrew consent	0	0	0	0	2	0	1	0
32-Day Follow-Up Period Family doctor OK'd participant, per call	0	0	1	0	0	0	0	0
32-Day Follow-Up Period withdrew from Day 5, D32 form not done	0	1	0	0	0	0	0	0
182-Day Follow-Up Period Death	3	3	11	12	9	0	0	1
182-Day Follow-Up Period Alive, per national insurance system	1	0	0	0	0	0	0	0
182-Day Follow-Up Period Participant withdrew consent	0	0	0	0	1	0	1	0
182-Day Follow-Up Period Alive, per Family doctor	0	0	0	0	1	0	0	0
182-Day Follow-Up Period Alive, per civil unit	0	0	0	0	1	0	0	0
182-Day Follow-Up Period Vital status collected via EMR	0	0	0	1	0	0	0	0
182-Day Follow-Up Period withdrew from D5, D32/182 forms not done	0	1	0	0	0	0	0	0
182-Day Follow-Up Period No cont D182 FU, Sponsor admin reason	0	0	0	0	0	5	3	4

Baseline Characteristics

Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo - Part I n=48 Participants Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)	BMS-986231 - Part I n=49 Participants Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)	Placebo - Part II n=71 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Total n=329 Participants Total of all reporting groups
Age, Continuous	66.0 Years STANDARD_DEVIATION 12.23 • n=93 Participants	64.6 Years STANDARD_DEVIATION 12.23 • n=4 Participants	67.3 Years STANDARD_DEVIATION 11.52 • n=27 Participants	69.2 Years STANDARD_DEVIATION 11.41 • n=483 Participants	70.0 Years STANDARD_DEVIATION 11.52 • n=36 Participants	65.3 Years STANDARD_DEVIATION 17.88 • n=10 Participants	69.5 Years STANDARD_DEVIATION 13.31 • n=115 Participants	76.7 Years STANDARD_DEVIATION 10.48 • n=40 Participants	67.9 Years STANDARD_DEVIATION 11.94 • n=8 Participants
Age, Customized < 65 years	17 Participants n=93 Participants	24 Participants n=4 Participants	21 Participants n=27 Participants	23 Participants n=483 Participants	19 Participants n=36 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=40 Participants	111 Participants n=8 Participants
Age, Customized 65 -to <=75 years	22 Participants n=93 Participants	15 Participants n=4 Participants	36 Participants n=27 Participants	26 Participants n=483 Participants	30 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=40 Participants	132 Participants n=8 Participants
Age, Customized >75 years	9 Participants n=93 Participants	10 Participants n=4 Participants	14 Participants n=27 Participants	22 Participants n=483 Participants	23 Participants n=36 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	3 Participants n=40 Participants	86 Participants n=8 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants	20 Participants n=483 Participants	15 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=40 Participants	74 Participants n=8 Participants
Sex: Female, Male Male	40 Participants n=93 Participants	39 Participants n=4 Participants	53 Participants n=27 Participants	51 Participants n=483 Participants	57 Participants n=36 Participants	6 Participants n=10 Participants	5 Participants n=115 Participants	4 Participants n=40 Participants	255 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	9 Participants n=27 Participants	11 Participants n=483 Participants	11 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	32 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=93 Participants	45 Participants n=4 Participants	18 Participants n=27 Participants	23 Participants n=483 Participants	20 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	150 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	3 Participants n=4 Participants	44 Participants n=27 Participants	37 Participants n=483 Participants	41 Participants n=36 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=40 Participants	147 Participants n=8 Participants
Race/Ethnicity, Customized White	35 Participants n=93 Participants	37 Participants n=4 Participants	63 Participants n=27 Participants	62 Participants n=483 Participants	66 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	263 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	11 Participants n=93 Participants	11 Participants n=4 Participants	4 Participants n=27 Participants	7 Participants n=483 Participants	4 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	37 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	2 Participants n=36 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=40 Participants	24 Participants n=8 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	5 Participants n=8 Participants

PRIMARY outcome

Timeframe: From start of infusion up to 6 hours post end of infusion

Population: All treated participants

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion clinically relevant hypotension	20.4 Percentage of participants Interval 10.24 to 34.34	18.3 Percentage of participants Interval 10.13 to 29.27	8.3 Percentage of participants Interval 2.32 to 19.98	21.1 Percentage of participants Interval 12.33 to 32.44	34.7 Percentage of participants Interval 23.88 to 46.86	0 Percentage of participants Interval 0.0 to 45.93	33.3 Percentage of participants Interval 4.33 to 77.72	50.0 Percentage of participants Interval 11.81 to 88.19
Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion symptoms of hypotension	6.1 Percentage of participants Interval 1.28 to 16.87	1.4 Percentage of participants Interval 0.04 to 7.6	2.1 Percentage of participants Interval 0.05 to 11.07	2.8 Percentage of participants Interval 0.34 to 9.81	8.3 Percentage of participants Interval 3.12 to 17.26	0 Percentage of participants Interval 0.0 to 45.93	0 Percentage of participants Interval 0.0 to 45.93	0 Percentage of participants Interval 0.0 to 45.93
Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion confirmed SBP < 90 mmHg	20.4 Percentage of participants Interval 10.24 to 34.34	18.3 Percentage of participants Interval 10.13 to 29.27	6.3 Percentage of participants Interval 1.31 to 17.2	21.1 Percentage of participants Interval 12.33 to 32.44	29.2 Percentage of participants Interval 19.05 to 41.07	0 Percentage of participants Interval 0.0 to 45.93	33.3 Percentage of participants Interval 4.33 to 77.72	50.0 Percentage of participants Interval 11.81 to 88.19

SECONDARY outcome

Timeframe: 0, 24, 48, 72, 120 hour or discharge; Day 32

Population: All treated participants

Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 72 hour	-373.86 pmol/L Standard Deviation 702.530	-249.26 pmol/L Standard Deviation 655.999	-396.21 pmol/L Standard Deviation 675.761	-118.86 pmol/L Standard Deviation 900.798	-293.94 pmol/L Standard Deviation 685.681	-433.08 pmol/L Standard Deviation 761.573	9.89 pmol/L Standard Deviation 523.754	-229.56 pmol/L Standard Deviation 809.850
Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 120 hour	-409.53 pmol/L Standard Deviation 751.624	-140.60 pmol/L Standard Deviation 1358.127	-541.36 pmol/L Standard Deviation 773.006	-76.20 pmol/L Standard Deviation 993.110	-390.21 pmol/L Standard Deviation 717.114	-434.36 pmol/L Standard Deviation 659.528	-379.06 pmol/L Standard Deviation 244.917	-552.55 pmol/L Standard Deviation 824.009
Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 24 hour	-364.46 pmol/L Standard Deviation 456.158	-147.96 pmol/L Standard Deviation 452.239	-270.88 pmol/L Standard Deviation 400.320	-340.74 pmol/L Standard Deviation 430.639	-416.91 pmol/L Standard Deviation 503.825	-129.70 pmol/L Standard Deviation 255.716	-165.93 pmol/L Standard Deviation 185.910	-397.60 pmol/L Standard Deviation 330.721
Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 48 hour	-510.51 pmol/L Standard Deviation 592.734	-210.87 pmol/L Standard Deviation 580.487	-405.06 pmol/L Standard Deviation 591.711	-300.87 pmol/L Standard Deviation 725.268	-472.32 pmol/L Standard Deviation 610.590	-329.24 pmol/L Standard Deviation 646.985	-251.73 pmol/L Standard Deviation 243.794	-497.35 pmol/L Standard Deviation 725.286
Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 Day 32	-91.61 pmol/L Standard Deviation 2254.397	-321.73 pmol/L Standard Deviation 600.297	-202.07 pmol/L Standard Deviation 799.169	-361.73 pmol/L Standard Deviation 782.881	-476.86 pmol/L Standard Deviation 716.072	-556.69 pmol/L Standard Deviation 1288.342	-343.64 pmol/L Standard Deviation 377.590	-706.11 pmol/L Standard Deviation 1111.877

SECONDARY outcome

Timeframe: Hours 6, 12, 24, 48, and 72

Population: All treated participants

Endpoint was measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72. Participants were asked to report their absolute current severity of dyspnea on an 11-point numerical rating scale (NRS; range 0 to 10). The numerical rating scale (NRS) was used to assess the degree of dyspnea (breathlessness), measured using an 11-point scale provided by the Sponsor. A score of 0 represents "I am not breathless at all" and 10 represents "I am the most breathless I can possibly imagine".

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 6 hour	-1.5 Scores on a scale Standard Deviation 1.64	-1.1 Scores on a scale Standard Deviation 1.90	-1.5 Scores on a scale Standard Deviation 1.84	-1.7 Scores on a scale Standard Deviation 1.94	-1.7 Scores on a scale Standard Deviation 2.13	-0.3 Scores on a scale Standard Deviation 1.03	0.0 Scores on a scale Standard Deviation 2.90	-1.3 Scores on a scale Standard Deviation 3.44
Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 72 hour	-3.7 Scores on a scale Standard Deviation 2.22	-3.2 Scores on a scale Standard Deviation 3.19	-2.9 Scores on a scale Standard Deviation 2.23	-3.9 Scores on a scale Standard Deviation 2.28	-3.2 Scores on a scale Standard Deviation 2.73	-1.2 Scores on a scale Standard Deviation 2.14	-1.2 Scores on a scale Standard Deviation 3.19	-2.0 Scores on a scale Standard Deviation 2.00
Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 24 hour	-2.1 Scores on a scale Standard Deviation 2.19	-2.1 Scores on a scale Standard Deviation 2.82	-2.0 Scores on a scale Standard Deviation 2.50	-2.9 Scores on a scale Standard Deviation 2.68	-2.2 Scores on a scale Standard Deviation 2.42	-0.8 Scores on a scale Standard Deviation 1.72	-1.5 Scores on a scale Standard Deviation 3.02	-1.2 Scores on a scale Standard Deviation 2.14
Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 12 hour	-2.2 Scores on a scale Standard Deviation 1.73	-1.7 Scores on a scale Standard Deviation 2.75	-2.1 Scores on a scale Standard Deviation 2.38	-2.4 Scores on a scale Standard Deviation 2.38	-2.0 Scores on a scale Standard Deviation 2.49	-1.0 Scores on a scale Standard Deviation 1.79	-0.2 Scores on a scale Standard Deviation 3.37	-1.4 Scores on a scale Standard Deviation 4.22
Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 48 hour	-2.6 Scores on a scale Standard Deviation 2.51	-2.8 Scores on a scale Standard Deviation 3.00	-2.8 Scores on a scale Standard Deviation 2.15	-3.4 Scores on a scale Standard Deviation 2.44	-2.8 Scores on a scale Standard Deviation 2.45	-1.2 Scores on a scale Standard Deviation 1.47	-0.8 Scores on a scale Standard Deviation 3.43	-2.0 Scores on a scale Standard Deviation 1.67

SECONDARY outcome

Timeframe: From start of infusion up to 6 hours post end of infusion

Population: All treated participants

The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion	6.1 Percentage of participants Interval 1.28 to 16.87	1.4 Percentage of participants Interval 0.04 to 7.6	2.1 Percentage of participants Interval 0.05 to 11.07	2.8 Percentage of participants Interval 0.34 to 9.81	8.3 Percentage of participants Interval 3.12 to 17.26	0 Percentage of participants Interval 0.0 to 45.93	0 Percentage of participants Interval 0.0 to 45.93	0 Percentage of participants Interval 0.0 to 45.93

SECONDARY outcome

Timeframe: From start of infusion up to 6 hours post end of infusion

Population: All treated participants

The percentage of participants experiencing SBP \< 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value)	20.4 Percentage of participants Interval 10.24 to 34.34	18.3 Percentage of participants Interval 10.13 to 29.27	6.3 Percentage of participants Interval 1.31 to 17.2	21.1 Percentage of participants Interval 12.33 to 32.44	29.2 Percentage of participants Interval 19.05 to 41.07	0 Percentage of participants Interval 0.0 to 45.93	33.3 Percentage of participants Interval 4.33 to 77.72	50.0 Percentage of participants Interval 11.81 to 88.19

SECONDARY outcome

Timeframe: 32 days

Population: All treated participants

Number of participants who experienced an in-study SAE. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32	14 Participants	23 Participants	11 Participants	15 Participants	15 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 120 hours (for AEs); up to 32 days (for SAEs)

Population: All treated participants Note: Discontinuation due to hypotension occurred per protocol-mandated lowering of blood pressure to \< 90 mmHg.

Number of participants who discontinued study treatment due to hypotension. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Hypotension defined as systolic blood pressure (SBP) \< 90 mmHg.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Number of Participants Who Discontinued Due to Hypotension	8 Participants	7 Participants	4 Participants	13 Participants	16 Participants	0 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: up to 120 hours (for AEs); up to 32 days (for SAEs)

Population: All treated participants Note: Discontinuation due to decreased blood pressure occurred per protocol-mandated lowering of blood pressure to \< 95 mmHg.

Number of participants who discontinued study treatment, experienced a down-titration (dose reduction) or dose interruption due to decreased blood pressure/hypotension are reported below. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. If the participant experienced systolic blood pressure (SBP) \< 95 mm Hg, without symptoms related to hypotension, the measurement was repeated within 15 minutes. If the SBP remained \< 95 mm Hg, the dose reduction occurred.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure discontinuation	8 Participants	7 Participants	4 Participants	13 Participants	15 Participants	0 Participants	1 Participants	3 Participants
Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure interruption	4 Participants	4 Participants	3 Participants	12 Participants	13 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure down-titration	9 Participants	9 Participants	3 Participants	10 Participants	25 Participants	0 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: up to 120 hours

Population: All treated participants

Number of participants who experienced an in-study AE. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours	39 Participants	48 Participants	31 Participants	48 Participants	55 Participants	2 Participants	6 Participants	6 Participants

SECONDARY outcome

Timeframe: through 182 days

Population: All treated participants

Number of participants who died (all- cause and CV related) through Day 182. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 CV=Cardiovascular

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 All-cause	3 Participants Interval 1.28 to 16.87	11 Participants Interval 8.0 to 26.03	3 Participants Interval 1.31 to 17.2	12 Participants Interval 9.05 to 27.66	9 Participants Interval 5.88 to 22.41	0 Participants Interval 0.0 to 45.93	0 Participants Interval 0.0 to 45.93	1 Participants Interval 0.42 to 64.12
Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 CV-related	2 Participants Interval 0.5 to 13.98	9 Participants Interval 5.96 to 22.7	3 Participants Interval 1.31 to 17.2	10 Participants Interval 6.97 to 24.38	4 Participants Interval 1.53 to 13.62	0 Participants Interval 0.0 to 45.93	0 Participants Interval 0.0 to 45.93	0 Participants Interval 0.0 to 45.93

SECONDARY outcome

Timeframe: from baseline to Hour 24, 48, and 72

Population: All treated participants

Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Troponin T From Baseline to Hour 24, 48, and 72 72 hour	6.76 ng/L Standard Deviation 66.673	-1.44 ng/L Standard Deviation 16.472	6.07 ng/L Standard Deviation 30.033	5.00 ng/L Standard Deviation 65.766	-13.05 ng/L Standard Deviation 68.276	-10.50 ng/L Standard Deviation 12.145	248.00 ng/L Standard Deviation 433.581	-15.00 ng/L Standard Deviation 25.169
Change in Troponin T From Baseline to Hour 24, 48, and 72 24 hour	-1.31 ng/L Standard Deviation 12.278	-1.80 ng/L Standard Deviation 11.266	4.11 ng/L Standard Deviation 27.303	-3.45 ng/L Standard Deviation 20.030	-8.09 ng/L Standard Deviation 37.864	-4.67 ng/L Standard Deviation 3.983	1.33 ng/L Standard Deviation 5.750	-7.67 ng/L Standard Deviation 16.669
Change in Troponin T From Baseline to Hour 24, 48, and 72 48 hour	14.56 ng/L Standard Deviation 81.979	-2.88 ng/L Standard Deviation 16.424	-0.93 ng/L Standard Deviation 22.714	8.08 ng/L Standard Deviation 71.672	-11.15 ng/L Standard Deviation 45.495	-10.67 ng/L Standard Deviation 10.633	49.50 ng/L Standard Deviation 118.417	-8.40 ng/L Standard Deviation 25.501

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

Number of participants who experienced an in-study Hematology marked laboratory abnormality (reported in \> 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology low erythrocytes values	1 Participants	1 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology low leukocyte counts	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology high leukocyte counts	2 Participants	5 Participants	5 Participants	4 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology low hemoglobin values	5 Participants	5 Participants	4 Participants	6 Participants	4 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology low platelet values	2 Participants	2 Participants	4 Participants	7 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology low neutrophils values	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology low hematocrit values	1 Participants	1 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

Number of participants who experienced an in-study Chemistry marked laboratory abnormality (reported in \> 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high urate values	15 Participants	10 Participants	10 Participants	20 Participants	8 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high bilirubin values	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high bicarbonate values	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry low albumin values	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry low bicarbonate values	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry low sodium values	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry low calcium values	0 Participants	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high blood urea nitrogen values	16 Participants	23 Participants	23 Participants	23 Participants	18 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high potassium values	5 Participants	6 Participants	2 Participants	7 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high alanine aminotransferase (ALT) values	1 Participants	5 Participants	6 Participants	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high alkaline phosphatase values	0 Participants	2 Participants	5 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry low protein values	9 Participants	3 Participants	3 Participants	8 Participants	4 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high asparate aminotransferase values	0 Participants	4 Participants	4 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry low chloride counts	2 Participants	1 Participants	1 Participants	4 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high creatine kinase values	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high protein values	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry high sodium values	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

Number of participants who experienced an in-study Urinalysis marked laboratory abnormality (reported in \> 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis high protein values	11 Participants	16 Participants	10 Participants	13 Participants	17 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis high erythrocyte values	1 Participants	1 Participants	1 Participants	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis high leukocytes values	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants with a 120-hour evaluation

The change in baseline for vital signs was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=26 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=50 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=29 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=48 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=44 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Vital Signs From Baseline to 120 Hours - Blood Pressure systolic blood pressure, mmHg	0.0 mmHg Standard Deviation 17.75	-4.3 mmHg Standard Deviation 15.23	-6.8 mmHg Standard Deviation 16.60	-7.9 mmHg Standard Deviation 15.60	-8.8 mmHg Standard Deviation 14.01	-10.3 mmHg Standard Deviation 15.60	-17.5 mmHg Standard Deviation 9.14	-6.2 mmHg Standard Deviation 16.44
Change in Vital Signs From Baseline to 120 Hours - Blood Pressure diastolic blood pressure, mmHg	-1.9 mmHg Standard Deviation 13.53	-4.4 mmHg Standard Deviation 12.99	-4.0 mmHg Standard Deviation 12.67	-3.4 mmHg Standard Deviation 14.37	-1.6 mmHg Standard Deviation 10.83	1.7 mmHg Standard Deviation 16.24	-15.7 mmHg Standard Deviation 19.08	-9.3 mmHg Standard Deviation 14.45

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for vital signs was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Vital Signs From Baseline to 120 Hours - Heart Rate	-9.1 beats/min Standard Deviation 17.13	-8.3 beats/min Standard Deviation 15.55	-1.8 beats/min Standard Deviation 15.53	-4.6 beats/min Standard Deviation 15.40	-6.3 beats/min Standard Deviation 15.60	-6.7 beats/min Standard Deviation 21.88	-3.0 beats/min Standard Deviation 13.31	3.8 beats/min Standard Deviation 11.55

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for vital signs was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate	-3.0 breaths/min Standard Deviation 4.82	-2.9 breaths/min Standard Deviation 3.80	-2.6 breaths/min Standard Deviation 3.93	-2.6 breaths/min Standard Deviation 4.33	-1.8 breaths/min Standard Deviation 3.96	-2.3 breaths/min Standard Deviation 2.88	0.0 breaths/min Standard Deviation 9.98	-1.4 breaths/min Standard Deviation 3.58

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for vital signs was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Vital Signs From Baseline to 120 Hours - Temperature	0.09 degrees C Standard Deviation 0.649	0.04 degrees C Standard Deviation 0.427	-0.04 degrees C Standard Deviation 0.643	0.00 degrees C Standard Deviation 0.342	-0.05 degrees C Standard Deviation 0.481	-0.47 degrees C Standard Deviation 0.650	-0.27 degrees C Standard Deviation 0.535	0.44 degrees C Standard Deviation 0.541

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for ECGs was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=5 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate	-6.8 beats/min Standard Deviation 21.31	-7.1 beats/min Standard Deviation 17.46	-5.3 beats/min Standard Deviation 9.36	-5.1 beats/min Standard Deviation 18.64	-6.1 beats/min Standard Deviation 17.33	2.0 beats/min Standard Deviation 10.72	-13.0 beats/min Standard Deviation 12.62	-5.2 beats/min Standard Deviation 14.85

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for ECGs was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration QRS Duration, Aggregate, msec	-0.1 msec Standard Deviation 12.46	1.6 msec Standard Deviation 20.29	5.1 msec Standard Deviation 22.19	-1.6 msec Standard Deviation 13.22	2.7 msec Standard Deviation 16.77	-3.0 msec Standard Deviation 4.80	-2.5 msec Standard Deviation 7.20	3.0 msec Standard Deviation 4.38
Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration QTcF Interval, Aggregate, msec	-13.9 msec Standard Deviation 41.56	-4.0 msec Standard Deviation 51.04	-27.5 msec Standard Deviation 41.79	-4.0 msec Standard Deviation 33.59	-10.3 msec Standard Deviation 37.63	-24.8 msec Standard Deviation 20.00	-8.8 msec Standard Deviation 22.35	3.2 msec Standard Deviation 22.93
Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration PR Interval, Aggregate, msec	-2.3 msec Standard Deviation 32.11	-0.1 msec Standard Deviation 23.49	-17.4 msec Standard Deviation 66.31	10.9 msec Standard Deviation 22.02	2.0 msec Standard Deviation 25.41	-1.5 msec Standard Deviation 16.50	10.4 msec Standard Deviation 26.32	6.0 msec Standard Deviation 30.10
Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration QT Interval, Aggregate, msec	7.2 msec Standard Deviation 48.25	8.7 msec Standard Deviation 53.17	-10.6 msec Standard Deviation 49.20	5.8 msec Standard Deviation 42.19	-0.3 msec Standard Deviation 45.39	-30.0 msec Standard Deviation 28.17	5.7 msec Standard Deviation 24.41	16.5 msec Standard Deviation 50.22

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for physical measurements was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Physical Measurements From Baseline to 120 Hours	0.10 kg Standard Deviation 0.285	-2.87 kg Standard Deviation 4.447	0.00 kg Standard Deviation 0383	-2.96 kg Standard Deviation 4.231	-1.83 kg Standard Deviation 5.295	-3.58 kg Standard Deviation 2.182	-3.97 kg Standard Deviation 2.160	-6.08 kg Standard Deviation 4.009

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants with a 120-hour evaluation

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=23 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=41 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=30 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=36 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=39 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L leukocyte, x10^9 c/L	-1.38 x10^9 cells/L Standard Deviation 1.892	-0.20 x10^9 cells/L Standard Deviation 4.370	0.12 x10^9 cells/L Standard Deviation 3.078	0.20 x10^9 cells/L Standard Deviation 2.549	-0.09 x10^9 cells/L Standard Deviation 1.980	—	—	—
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L platelet, x10^9 c/L	-5.77 x10^9 cells/L Standard Deviation 34.666	1.84 x10^9 cells/L Standard Deviation 40.808	5.63 x10^9 cells/L Standard Deviation 31.679	3.26 x10^9 cells/L Standard Deviation 37.888	1.26 x10^9 cells/L Standard Deviation 31.135	—	—	—

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants with a 120-hour evaluation

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=23 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=46 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=30 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=42 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=43 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L hemoglobin, g/L	-0.70 g/L Standard Deviation 8.573	1.20 g/L Standard Deviation 11.487	-0.67 g/L Standard Deviation 11.851	0.94 g/L Standard Deviation 11.684	1.38 g/L Standard Deviation 9.161	—	—	—
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L protein, g/L	2.77 g/L Standard Deviation 5.839	0.57 g/L Standard Deviation 8.178	1.10 g/L Standard Deviation 6.172	0.38 g/L Standard Deviation 6.048	-0.05 g/L Standard Deviation 5.367	—	—	—

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L blood urea nitrogen, mmol/L	0.32 mmol/L Standard Deviation 3.164	1.96 mmol/L Standard Deviation 3.920	4.01 mmol/L Standard Deviation 5.474	2.15 mmol/L Standard Deviation 5.016	1.24 mmol/L Standard Deviation 3.655	—	—	—
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L urate, mmol/L	0.01 mmol/L Standard Deviation 0.108	-0.01 mmol/L Standard Deviation 0.126	0.06 mmol/L Standard Deviation 0.154	0.04 mmol/L Standard Deviation 0.147	-0.03 mmol/L Standard Deviation 0.111	—	—	—
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L potassium, mmol/L	0.28 mmol/L Standard Deviation 0.513	0.21 mmol/L Standard Deviation 0.692	0.19 mmol/L Standard Deviation 0.697	0.13 mmol/L Standard Deviation 0.558	0.15 mmol/L Standard Deviation 0.651	—	—	—

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L alkaline phosphatase, U/L	1.65 U/L Standard Deviation 11.052	-1.31 U/L Standard Deviation 25.186	-1.00 U/L Standard Deviation 28.018	5.43 U/L Standard Deviation 26.007	-0.49 U/L Standard Deviation 21.474	—	—	—
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L alanine aminotransferase (ALT), U/L	-2.73 U/L Standard Deviation 11.089	-3.22 U/L Standard Deviation 102.038	148.13 U/L Standard Deviation 837.833	30.36 U/L Standard Deviation 189.310	-13.07 U/L Standard Deviation 76.357	—	—	—
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L asparate aminotransferase, U/L	-2.77 U/L Standard Deviation 10.277	-11.15 U/L Standard Deviation 127.903	214.77 U/L Standard Deviation 1204.410	10.81 U/L Standard Deviation 65.009	-10.00 U/L Standard Deviation 52.075	—	—	—

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL	NA mg/dL Standard Deviation NA 120 hour data not collected	NA mg/dL Standard Deviation NA 120 hour data not collected	NA mg/dL Standard Deviation NA 120 hour data not collected	NA mg/dL Standard Deviation NA 120 hour data not collected	NA mg/dL Standard Deviation NA 120 hour data not collected	—	—	—

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=49 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=71 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=48 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II n=71 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L	0.02 x10^12 c/L Standard Deviation 0.305	0.04 x10^12 c/L Standard Deviation 0.409	-0.02 x10^12 c/L Standard Deviation 0.394	0.04 x10^12 c/L Standard Deviation 0.481	0.09 x10^12 c/L Standard Deviation 0.337	—	—	—

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=5 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)	74.13 nmol/L Standard Deviation 110.919	131.64 nmol/L Standard Deviation 407.611	79.38 nmol/L Standard Deviation 192.568	—	—	—	—	—

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=5 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)	-1.50 µmol/L Standard Deviation 6.775	12.40 µmol/L Standard Deviation 23.891	4.33 µmol/L Standard Deviation 17.728	—	—	—	—	—

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=5 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)	0.17 mg/L Standard Deviation 0.150	0.25 mg/L Standard Deviation 0.077	0.18 mg/L Standard Deviation 0.268	—	—	—	—	—

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=5 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=5 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion	-1.22 Fractional Potassium Excretion percent Standard Deviation 4.926	-12.34 Fractional Potassium Excretion percent Standard Deviation 13.316	4.88 Fractional Potassium Excretion percent Standard Deviation 8.009	—	—	—	—	—

SECONDARY outcome

Timeframe: to 120 hours

Population: All treated participants

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Outcome measures

Outcome measures
Measure	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 Participants BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=5 Participants BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	Placebo - Part II (Japan Cohort) n=6 Participants Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion	-2.62 Fractional Sodium Excretion percent Standard Deviation 4.538	-5.50 Fractional Sodium Excretion percent Standard Deviation 7.984	0.02 Fractional Sodium Excretion percent Standard Deviation 2.076	—	—	—	—	—

Adverse Events

Placebo - Part I

Serious events: 11 serious events

Other events: 18 other events

Deaths: 3 deaths

BMS-986231 - Part I

Serious events: 14 serious events

Other events: 40 other events

Deaths: 3 deaths

Placebo - Part II

Serious events: 23 serious events

Other events: 47 other events

Deaths: 11 deaths

BMS-986231 6 µg/kg/Min - Part II

Serious events: 15 serious events

Other events: 43 other events

Deaths: 12 deaths

BMS-986231 12 µg/kg/Min - Part II

Serious events: 15 serious events

Other events: 54 other events

Deaths: 9 deaths

Placebo - Part II (Japan Cohort)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo - Part I n=48 participants at risk Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)	BMS-986231 - Part I n=49 participants at risk Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)	Placebo - Part II n=71 participants at risk Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours	BMS-986231 6 µg/kg/Min - Part II n=71 participants at risk BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 participants at risk BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 participants at risk Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 participants at risk BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 participants at risk BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Cardiac disorders CORONARY ARTERY STENOSIS	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders ANGINA PECTORIS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders CARDIAC FAILURE	4.2% 2/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	12.2% 6/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	11.3% 8/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	9.7% 7/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	4.2% 2/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders CARDIAC FAILURE CONGESTIVE	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders CARDIOGENIC SHOCK	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	4.2% 3/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders CARDIORENAL SYNDROME	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders CARDIAC FAILURE ACUTE	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders CARDIAC ARREST	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders VENTRICULAR FIBRILLATION	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders CARDIAC FAILURE CHRONIC	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders SINUS BRADYCARDIA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Renal and urinary disorders ACUTE KIDNEY INJURY	6.2% 3/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders VENTRICULAR TACHYCARDIA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Infections and infestations ACINETOBACTER BACTERAEMIA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Infections and infestations PNEUMONIA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Infections and infestations BRONCHITIS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Infections and infestations CELLULITIS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Infections and infestations SEPTIC SHOCK	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Infections and infestations ENDOCARDITIS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Infections and infestations ERYSIPELAS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Psychiatric disorders DELIRIUM	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Psychiatric disorders ORGANIC BRAIN SYNDROME	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Respiratory, thoracic and mediastinal disorders HYPERCAPNIA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Metabolism and nutrition disorders HYPERNATRAEMIA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Metabolism and nutrition disorders FLUID OVERLOAD	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Nervous system disorders ALTERED STATE OF CONSCIOUSNESS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Renal and urinary disorders BLADDER MASS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Renal and urinary disorders END STAGE RENAL DISEASE	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Renal and urinary disorders RENAL FAILURE	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Investigations ELECTROCARDIOGRAM QRS COMPLEX PROLONGED	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Vascular disorders ANGIOPATHY	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Vascular disorders HYPOTENSION	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Vascular disorders ILIAC ARTERY OCCLUSION	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Vascular disorders PERIPHERAL ARTERY OCCLUSION	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Hepatobiliary disorders HEPATIC CONGESTION	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Injury, poisoning and procedural complications WRIST FRACTURE	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment

Other adverse events

Other adverse events
Measure	Placebo - Part I n=48 participants at risk Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)	BMS-986231 - Part I n=49 participants at risk Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)	Placebo - Part II n=71 participants at risk Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours	BMS-986231 6 µg/kg/Min - Part II n=71 participants at risk BMS-986231 dose of 6 µg/kg/min for 48 hours	BMS-986231 12 µg/kg/Min - Part II n=72 participants at risk BMS-986231 dose of 12 µg/kg/min for 48 hours	Placebo - Part II (Japan Cohort) n=6 participants at risk Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) n=6 participants at risk BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) n=6 participants at risk BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
Vascular disorders HYPOTENSION	10.4% 5/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	28.6% 14/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	21.1% 15/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	28.2% 20/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	43.1% 31/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	50.0% 3/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	66.7% 4/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders CARDIAC FAILURE	4.2% 2/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	12.2% 6/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	11.3% 8/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	9.7% 7/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders VENTRICULAR TACHYCARDIA	6.2% 3/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Nervous system disorders HEADACHE	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	12.2% 6/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	7.0% 5/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	5.6% 4/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Nervous system disorders DIZZINESS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	6.1% 3/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Metabolism and nutrition disorders HYPERURICAEMIA	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	8.2% 4/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	4.2% 3/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Metabolism and nutrition disorders HYPOKALAEMIA	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	6.1% 3/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	9.9% 7/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	11.3% 8/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	11.1% 8/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Psychiatric disorders INSOMNIA	4.2% 2/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	4.1% 2/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	8.5% 6/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Renal and urinary disorders ACUTE KIDNEY INJURY	6.2% 3/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Investigations BLOOD CREATININE INCREASED	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	5.6% 4/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Renal and urinary disorders RENAL IMPAIRMENT	6.2% 3/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	4.2% 3/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Gastrointestinal disorders CONSTIPATION	4.2% 2/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Gastrointestinal disorders DIARRHOEA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Infections and infestations URINARY TRACT INFECTION	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	4.1% 2/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	4.2% 3/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	4.2% 3/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Metabolism and nutrition disorders HYPOGLYCAEMIA	2.1% 1/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.0% 1/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Eye disorders VITREOUS DETACHMENT	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	4.2% 2/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	2.8% 2/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	1.4% 1/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment
Skin and subcutaneous tissue disorders RASH PRURITIC	0.00% 0/48 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/49 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/71 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/72 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	16.7% 1/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment	0.00% 0/6 • Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment

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