Evaluate the Safety and Efficacy of 48-Hour Infusions of... | NCT03016325

ID	Type	Description	Link
2016-001685-29	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Part 1 Cohort 1 HNO Donor	Experimental	Drug: HNO Donor
Placebo Part 1 Cohort 1	Placebo Comparator	Drug: Placebo
Part 2 Cohort 2 HNO Donor- low dose	Experimental	Drug: HNO Donor
Part 2 Cohort 2 HNO Donor- high dose	Experimental	Drug: HNO Donor
Placebo Part 2 Cohort 2	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
HNO Donor	Drug	Infusion	Part 1 Cohort 1 HNO Donor Part 2 Cohort 2 HNO Donor- high dose Part 2 Cohort 2 HNO Donor- low dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion	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	From start of infusion up to 6 hours post end of infusion

Secondary Outcomes

Measure	Description	Time Frame
Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32	Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)	0, 24, 48, 72, 120 hour or discharge; Day 32
Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72

Eligibility Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona Sarver Heart Center		Tucson	Arizona	85724	United States
University of Florida

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33248986	Derived	Felker GM, McMurray JJV, Cleland JG, O'Connor CM, Teerlink JR, Voors AA, Belohlavek J, Bohm M, Borentain M, Bueno H, Cole RT, DeSouza MM, Ezekowitz JA, Filippatos G, Lang NN, Kessler PD, Martinez FA, Mebazaa A, Metra M, Mosterd A, Pang PS, Ponikowski P, Sato N, Seiffert D, Ye J. Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study. JACC Heart Fail. 2021 Feb;9(2):146-157. doi: 10.1016/j.jchf.2020.10.012. Epub 2020 Nov 25.
30703258

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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)
FG001	BMS-986231 - Part I

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jun 21, 2017	Jun 22, 2020

Arm/Group Information

ID	Title	Description
BG000	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)
BG001	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)
BG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
BG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
BG004	BMS-986231 12 µg/kg/Min - Part II	BMS-986231 dose of 12 µg/kg/min for 48 hours
BG005	Placebo - Part II (Japan Cohort)	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
BG006	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
BG007	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
BG008	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00066.0± 12.23 BG00164.6± 12.23 BG00267.3± 11.52 BG003

Age, Customized

Age categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 65 years	BG00017 BG00124 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG00110 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0011 BG002

Race/Ethnicity, Customized

Race

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG00035 BG00137 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion

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

All treated participants

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004	BMS-986231 12 µg/kg/Min - Part II	BMS-986231 dose of 12 µg/kg/min for 48 hours
OG005	Placebo - Part II (Japan Cohort)	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
OG006	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
OG007	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants

Units	Counts
Participants	OG00048 OG00149 OG00271 OG003

Title

Denominators

Categories

clinically relevant hypotension

Title	Measurements
	OG0008.3(2.32 to 19.98) OG00120.4(10.24 to 34.34) OG00218.3(10.13 to 29.27)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Relative risk from placebo	2.45			2-Sided	95	0.83	14.53					Superiority	Part I, clinically relevant hypotension - relative risk
OG000 OG001

Secondary

Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32

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

All treated participants

Posted

Mean

Standard Deviation

pmol/L

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

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours

Secondary

Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72

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".

All treated participants

Posted

Mean

Standard Deviation

Scores on a scale

Hours 6, 12, 24, 48, and 72

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours

Secondary

Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion

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

All treated participants

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours

Secondary

Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value)

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.

All treated participants

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours

Secondary

Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32

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.

All treated participants

Posted

Number

Participants

32 days

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours

Secondary

Number of Participants Who Discontinued Due to Hypotension

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.

All treated participants

Note: Discontinuation due to hypotension occurred per protocol-mandated lowering of blood pressure to < 90 mmHg.

Posted

Number

Participants

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

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours

Secondary

Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure

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

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.

All treated participants

Note: Discontinuation due to decreased blood pressure occurred per protocol-mandated lowering of blood pressure to < 95 mmHg.

Posted

Number

Participants

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

ID	Title	Description
OG000	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)
OG001	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)

Secondary

Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours

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.

All treated participants

Posted

Number

Participants

up to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours

Secondary

Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182

Number of participants who died (all- cause and CV related) through Day 182.

Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

CV=Cardiovascular

All treated participants

Posted

Number

95% Confidence Interval

Participants

through 182 days

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours

Secondary

Change in Troponin T From Baseline to Hour 24, 48, and 72

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

All treated participants

Posted

Mean

Standard Deviation

ng/L

from baseline to Hour 24, 48, and 72

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004

Secondary

Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology

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

All treated participants

Posted

Number

Participants

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours

Secondary

Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry

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

All treated participants

Posted

Number

Participants

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours

Secondary

Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis

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

All treated participants

Posted

Number

Participants

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours

Secondary

Change in Vital Signs From Baseline to 120 Hours - Blood Pressure

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

All treated participants with a 120-hour evaluation

Posted

Mean

Standard Deviation

mmHg

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004	BMS-986231 12 µg/kg/Min - Part II

Secondary

Change in Vital Signs From Baseline to 120 Hours - Heart Rate

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

All treated participants

Posted

Mean

Standard Deviation

beats/min

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004	BMS-986231 12 µg/kg/Min - Part II

Secondary

Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate

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

All treated participants

Posted

Mean

Standard Deviation

breaths/min

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004	BMS-986231 12 µg/kg/Min - Part II

Secondary

Change in Vital Signs From Baseline to 120 Hours - Temperature

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

All treated participants

Posted

Mean

Standard Deviation

degrees C

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004	BMS-986231 12 µg/kg/Min - Part II

Secondary

Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate

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

All treated participants

Posted

Mean

Standard Deviation

beats/min

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004	BMS-986231 12 µg/kg/Min - Part II

Secondary

Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration

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

All treated participants

Posted

Mean

Standard Deviation

msec

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004	BMS-986231 12 µg/kg/Min - Part II

Secondary

Change in Physical Measurements From Baseline to 120 Hours

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

All treated participants

Posted

Mean

Standard Deviation

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004	BMS-986231 12 µg/kg/Min - Part II

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L

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

All treated participants with a 120-hour evaluation

Posted

Mean

Standard Deviation

x10^9 cells/L

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L

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

All treated participants with a 120-hour evaluation

Posted

Mean

Standard Deviation

g/L

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L

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

All treated participants

Posted

Mean

Standard Deviation

mmol/L

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L

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

All treated participants

Posted

Mean

Standard Deviation

U/L

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL

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

All treated participants

Posted

Mean

Standard Deviation

mg/dL

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L

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

All treated participants

Posted

Mean

Standard Deviation

x10^12 c/L

to 120 hours

ID	Title	Description
OG000	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)
OG001	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)
OG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
OG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours
OG004

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)

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

All treated participants

Posted

Mean

Standard Deviation

nmol/L

to 120 hours

ID	Title	Description
OG000	Placebo - Part II (Japan Cohort)	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
OG001	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
OG002	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants

Units	Counts
Participants

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)

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

All treated participants

Posted

Mean

Standard Deviation

µmol/L

to 120 hours

ID	Title	Description
OG000	Placebo - Part II (Japan Cohort)	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
OG001	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
OG002	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants

Units	Counts
Participants

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)

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

All treated participants

Posted

Mean

Standard Deviation

mg/L

to 120 hours

ID	Title	Description
OG000	Placebo - Part II (Japan Cohort)	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
OG001	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
OG002	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants

Units	Counts
Participants

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion

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

All treated participants

Posted

Mean

Standard Deviation

Fractional Potassium Excretion percent

to 120 hours

ID	Title	Description
OG000	Placebo - Part II (Japan Cohort)	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
OG001	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
OG002	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants

Units	Counts
Participants

Secondary

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion

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

All treated participants

Posted

Mean

Standard Deviation

Fractional Sodium Excretion percent

to 120 hours

ID	Title	Description
OG000	Placebo - Part II (Japan Cohort)	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
OG001	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
OG002	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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)	3	48	11	48	18	48
EG001	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)	3	49	14	49	40	49
EG002	Placebo - Part II	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours	11	71	23	71	47	71
EG003	BMS-986231 6 µg/kg/Min - Part II	BMS-986231 dose of 6 µg/kg/min for 48 hours	12	71	15	71	43	71
EG004	BMS-986231 12 µg/kg/Min - Part II	BMS-986231 dose of 12 µg/kg/min for 48 hours	9	72	15	72	54	72
EG005	Placebo - Part II (Japan Cohort)	Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants	0	6	1	6	2	6
EG006	BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants	0	6	0	6	6	6
EG007	BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)	BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants	1	6	1	6	6	6

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
CARDIAC FAILURE	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0002 affected48 at risk EG0016 affected49 at risk EG0028 affected71 at risk EG0032 affected71 at risk EG0047 affected72 at risk EG0050 affected6 at risk EG0060 affected6 at risk EG0070 affected6 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0002 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0001 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0001 affected48 at risk EG0011 affected49 at risk EG0023 affected71 at risk EG003
CARDIORENAL SYNDROME	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0011 affected49 at risk EG0021 affected71 at risk EG003
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0001 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0001 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0001 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
ANGINA PECTORIS	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0022 affected71 at risk EG003
SINUS BRADYCARDIA	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
VENTRICULAR ARRHYTHMIA	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
ACINETOBACTER BACTERAEMIA	Infections and infestations	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
CELLULITIS	Infections and infestations	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
ENDOCARDITIS	Infections and infestations	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
ERYSIPELAS	Infections and infestations	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0011 affected49 at risk EG0021 affected71 at risk EG003
DELIRIUM	Psychiatric disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
ORGANIC BRAIN SYNDROME	Psychiatric disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
HYPERCAPNIA	Respiratory, thoracic and mediastinal disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA version 22.0	Systematic Assessment		EG0001 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
SLEEP APNOEA SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
HYPERNATRAEMIA	Metabolism and nutrition disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA version 22.0	Systematic Assessment		EG0001 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA version 22.0	Systematic Assessment		EG0003 affected48 at risk EG0011 affected49 at risk EG0021 affected71 at risk EG003
BLADDER MASS	Renal and urinary disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
END STAGE RENAL DISEASE	Renal and urinary disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED	Investigations	MedDRA version 22.0	Systematic Assessment		EG0001 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
ANGIOPATHY	Vascular disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
ILIAC ARTERY OCCLUSION	Vascular disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
PERIPHERAL ARTERY OCCLUSION	Vascular disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA version 22.0	Systematic Assessment	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	EG0000 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
HEPATIC CONGESTION	Hepatobiliary disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA version 22.0	Systematic Assessment		EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
HYPOTENSION	Vascular disorders	MedDRA version 22.0	Systematic Assessment	EG0005 affected48 at risk EG00114 affected49 at risk EG00215 affected71 at risk EG00320 affected71 at risk EG00431 affected72 at risk EG0050 affected6 at risk EG0063 affected6 at risk EG0074 affected6 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA version 22.0	Systematic Assessment	EG0002 affected48 at risk EG0016 affected49 at risk EG0028 affected71 at risk EG003
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA version 22.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected49 at risk EG0022 affected71 at risk EG003
HEADACHE	Nervous system disorders	MedDRA version 22.0	Systematic Assessment	EG0001 affected48 at risk EG0016 affected49 at risk EG0025 affected71 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA version 22.0	Systematic Assessment	EG0000 affected48 at risk EG0013 affected49 at risk EG0020 affected71 at risk EG003
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA version 22.0	Systematic Assessment	EG0001 affected48 at risk EG0014 affected49 at risk EG0023 affected71 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA version 22.0	Systematic Assessment	EG0001 affected48 at risk EG0013 affected49 at risk EG0027 affected71 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA version 22.0	Systematic Assessment	EG0002 affected48 at risk EG0012 affected49 at risk EG0026 affected71 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA version 22.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected49 at risk EG0021 affected71 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA version 22.0	Systematic Assessment	EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA version 22.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected49 at risk EG0023 affected71 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA version 22.0	Systematic Assessment	EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA version 22.0	Systematic Assessment	EG0002 affected48 at risk EG0010 affected49 at risk EG0021 affected71 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA version 22.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected49 at risk EG0021 affected71 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA version 22.0	Systematic Assessment	EG0001 affected48 at risk EG0012 affected49 at risk EG0020 affected71 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA version 22.0	Systematic Assessment	EG0001 affected48 at risk EG0011 affected49 at risk EG0020 affected71 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA version 22.0	Systematic Assessment	EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA version 22.0	Systematic Assessment	EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
VITREOUS DETACHMENT	Eye disorders	MedDRA version 22.0	Systematic Assessment	EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA version 22.0	Systematic Assessment	EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA version 22.0	Systematic Assessment	EG0002 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003
RASH PRURITIC	Skin and subcutaneous tissue disorders	MedDRA version 22.0	Systematic Assessment	EG0000 affected48 at risk EG0010 affected49 at risk EG0020 affected71 at risk EG003

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases