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Clinical Trial Results:
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery

Summary
EudraCT number	2012-003942-33
Trial protocol	DK
Global end of trial date	07 Mar 2014

Results information
Results version number	v2(current)
This version publication date	18 May 2016
First version publication date	25 Jul 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set potential category issues

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

M13-796

ISRCTN number

US NCT number

NCT01777165

WHO universal trial number (UTN)

Sponsor organisation name

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation address

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire , United Kingdom, SL6 4XE

Public contact

Global Medical Information, AbbVie, 001 800-633-9110,

Scientific contact

Ann Eldred, MD, AbbVie, ann.eldred@abbvie.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

07 Mar 2014

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

07 Mar 2014

Was the trial ended prematurely?

Main objective of the trial

The study objective is to compare the safety and efficacy of doses of 800 mcg/kg, 1600 mcg/kg and 2100 mcg/kg intravenous (IV) infusions of ABT-719 to placebo in subjects who are at risk of acute kidney injury (AKI) and undergoing pre-defined on-pump cardiac surgery.

Protection of trial subjects

Subject and/or legal guardian read and understood the information provided about the study and gave written permission.

Background therapy

Evidence for comparator

Actual start date of recruitment

05 Feb 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Denmark: 49

Country: Number of subjects enrolled

United States: 191

Worldwide total number of subjects

240

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

162

85 years and over

Subject disposition

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Recruitment details

Subjects were enrolled at 39 investigative sites in Denmark and the United States.

Screening details

Screening visit occurred between Day -28 and Day -5 prior to surgery.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

A total of 6, 10-minute infusions administered 1) prior to skin incision; 2) before clamp release but at least 1 hour after the first dose 3) 6 hours (± 30 minutes) after clamp release; 4) 12 hours (± 30 minutes) after clamp release; 5) 24 hours (± 60 minutes) after clamp release; and 6) 48 hours (± 60 minutes) after clamp release.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Placebo administered by intravenous infusion

ABT-719 800 mcg/kg

Arm description

Six 10-minute infusions with a total dose of 800 mcg/kg ABT-719, administered 1) prior to skin incision (200 mcg/kg); 2) before clamp release but at least 1 hour after the first dose (400 mcg/kg); 3) 6 hours (± 30 minutes) after clamp release (200 mcg/kg); 4) 12 hours (± 30 minutes) after clamp release (0 mcg/kg); 5) 24 hours (± 60 minutes) after clamp release (0 mcg/kg); and 6) 48 hours (± 60 minutes) after clamp release (0 mcg/kg).

Arm type

Experimental

Investigational medicinal product name

ABT-719

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

ABT-719 administered by intravenous infusion

ABT-719 1600 mcg/kg

Arm description

Six 10-minute infusions with a total dose of 1600 mcg/kg ABT-719, administered 1) prior to skin incision (300 mcg/kg); 2) before clamp release but at least 1 hour after the first dose (600 mcg/kg); 3) 6 hours (± 30 minutes) after clamp release (200 mcg/kg); 4) 12 hours (± 30 minutes) after clamp release (200 mcg/kg); 5) 24 hours (± 60 minutes) after clamp release (200 mcg/kg); and 6) 48 hours (± 60 minutes) after clamp release (0 mcg/kg).

Arm type

Experimental

Investigational medicinal product name

ABT-719

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

ABT-719 administered by intravenous infusion

ABT-719 2100 mcg/kg

Arm description

Six 10-minute infusions with a total dose of 2100 mcg/kg ABT-719, administered 1) prior to skin incision (300 mcg/kg); 2) before clamp release but at least 1 hour after the first dose (600 mcg/kg); 3) 6 hours (± 30 minutes) after clamp release (300 mcg/kg); 4) 12 hours (± 30 minutes) after clamp release (300 mcg/kg); 5) 24 hours (± 60 minutes) after clamp release (300 mcg/kg); and 6) 48 hours (± 60 minutes) after clamp release (300 mcg/kg).

Arm type

Experimental

Investigational medicinal product name

ABT-719

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

ABT-719 administered by intravenous infusion

Number of subjects in period 1 ^[1]	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Started	59	57	59	56
Completed	51	54	55	49
Not completed	8	3	4	7
Other, not specified	8	3	4	7

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 240 subjects were enrolled; 9 subjects discontinued before receiving any study drug; and 231 subjects are included in the full analysis set (FAS).

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Reporting group title

ABT-719 800 mcg/kg

Reporting group description

Reporting group title

ABT-719 1600 mcg/kg

Reporting group description

Reporting group title

ABT-719 2100 mcg/kg

Reporting group description

Reporting group values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg	Total
Number of subjects	59	57	59	56	231
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	71.1 ± 9.39	68.9 ± 10.23	67.7 ± 12.54	68.6 ± 10.6	-
Gender categorical
Units: Subjects
Female	13	17	16	20	66
Male	46	40	43	36	165

End points

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Reporting group title

Placebo

Reporting group description

Reporting group title

ABT-719 800 mcg/kg

Reporting group description

Reporting group title

ABT-719 1600 mcg/kg

Reporting group description

Reporting group title

ABT-719 2100 mcg/kg

Reporting group description

Subject analysis set title

Placebo

Subject analysis set type

Per protocol

Subject analysis set description

All randomized subjects who received all 6 infusions of study drug and underwent the pre-defined on-pump cardiac surgery.

Subject analysis set title

ABT-719 800 mcg/kg

Subject analysis set type

Per protocol

Subject analysis set description

All randomized subjects who received all 6 infusions of study drug and underwent the pre-defined on-pump cardiac surgery.

Subject analysis set title

ABT-719 1600 mcg/kg

Subject analysis set type

Per protocol

Subject analysis set description

All randomized subjects who received all 6 infusions of study drug and underwent the pre-defined on-pump cardiac surgery.

Subject analysis set title

ABT-719 2100 mcg/kg

Subject analysis set type

Per protocol

Subject analysis set description

All randomized subjects who received all 6 infusions of study drug and underwent the pre-defined on-pump cardiac surgery.

Primary: Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Acute Kidney Injury Network (AKIN) Scoring Criteria

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End point title

Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Acute Kidney Injury Network (AKIN) Scoring Criteria

End point description

The AKIN is an evidence-based definition for AKI based on changes to serum creatinine (SCr), urine output (UO), and renal replacement therapy (RRT). The 3 severity grades are defined on the basis of the changes in SCr or UO where the worst of each criterion is used: Stage 1 (increased Cr x 1.5 or ≥ 0.3 mg/dL; UO < 0.5 mL/kg/hr x 6 hr), Stage 2 (increased Cr x 2; UO < 0.5 mL/kg/hr x 12 hr), and Stage 3 (increased Cr x 3 Cr ≥ 4 mg/dL with acute rise of ≥ 0.5 mg/dL; UO < 0.3 mL/kg/hr x 24 hr or anuria x 12 hr). A change in SCr of ≥ 26.2 µmol/L) defines the presence of AKI. The AKIN scoring criteria includes a time limit of 48 hours for diagnosis of AKI, and any patients receiving RRT are classified as Stage 3 AKI, regardless of the stage that the patient is in at the time of commencement of RRT. The number of subjects analyzed = all subjects in the full analysis set with available data.

End point type

Primary

End point timeframe

Day 0 (Surgery) to Day 7

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	58	55	59	56
Units: percentage of subjects
number (not applicable)
No	29.31	27.27	35.59	28.57
Stage 1	10.34	18.18	6.78	14.29
Stage 2	48.28	49.09	50.85	51.79
Stage 3	12.07	5.45	6.78	5.36
Any stage	70.69	72.73	64.41	71.43

Statistical analysis 1

Statistical analysis description

P-value from pairwise comparisons between each ABT-719 dose group and placebo using 2-sided Cochran-Mantel-Haenszel test after adjustment for type of surgery and SCr-based estimated glomerular filtration rate (eGFR).

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.848

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 2

Statistical analysis description

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

117

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.469

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3

Statistical analysis description

Comparison groups

Placebo v ABT-719 2100 mcg/kg

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.906

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 25% Reduction in Serum Creatinine Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

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End point title

Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 25% Reduction in Serum Creatinine Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

End point description

The percentage of subjects developing at least 1 of the composite events: death, needing RRT during the 90 day post-operative period, or having a ≥25% reduction in SCr eGFR at the Day 90 post-surgery visit. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	52	54	55	42
Units: percentage of subjects
number (not applicable)	19.23	12.96	10.91	20.41

No statistical analyses for this end point

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 50% Reduction in Serum Creatinine Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

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End point title

Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 50% Reduction in Serum Creatinine Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

End point description

The percentage of subjects developing at least 1 of the composite events: death, needing RRT during the 90 day post-operative period, or having a ≥50% reduction in SCr eGFR at the Day 90 post-surgery visit. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	52	54	55	49
Units: percentage of subjects
number (not applicable)	11.54	5.56	3.64	8.16

No statistical analyses for this end point

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 25% Reduction in S-Cystatin C Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

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End point title

Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 25% Reduction in S-Cystatin C Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

End point description

The percentage of subjects developing at least 1 of the composite events: death, needing RRT during the 90 day post-operative period, or having a ≥25% reduction in S-Cystatin C eGFR at the Day 90 post-surgery visit. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	52	54	55	49
Units: percentage of subjects
number (not applicable)	13.46	7.41	7.27	10.2

No statistical analyses for this end point

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 50% Reduction in S-Cystatin C Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

Top of page

End point title

Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 50% Reduction in S-Cystatin C Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

End point description

The percentage of subjects developing at least 1 of the composite events: death, needing RRT during the 90 day post-operative period, or having a ≥50% reduction in S-Cystatin C eGFR at the Day 90 post-surgery visit. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	49	52	52	46
Units: percentage of subjects
number (not applicable)	11.54	7.41	1.82	8.16

No statistical analyses for this end point

Secondary: Serum Neutrophil Gelatinase Associated Lipocalin (NGAL): Change from Baseline to Day 90

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End point title

Serum Neutrophil Gelatinase Associated Lipocalin (NGAL): Change from Baseline to Day 90

End point description

From repeated measures analysis. The least squares mean (LS mean) change from baseline to each visit in serum NGAL (ng/mL). Lower measures for NGAL are desirable. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	42	47	44	36
Units: ng/mL
least squares mean (standard error)	120.4 ± 38.6	78.5 ± 36.7	113.1 ± 37.8	113.7 ± 41.6

Statistical Analysis 1

Statistical analysis description

A mixed effects, repeated measures model including fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as fixed, continuous effects of baseline measurements and subject effects; the autoregressive variance-covariance structure is used.

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-41.9

Confidence interval

level

95%

sides

2-sided

lower limit

-146.3

upper limit

62.5

Variability estimate

Standard error of the mean

Dispersion value

53.2

Statistical Analysis 2

Statistical analysis description

Comparison groups

ABT-719 1600 mcg/kg v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-7.3

Confidence interval

level

95%

sides

2-sided

lower limit

-113.3

upper limit

62.5

Variability estimate

Standard error of the mean

Dispersion value

Statistical Analysis 3

Statistical analysis description

Comparison groups

Placebo v ABT-719 2100 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-6.8

Confidence interval

level

95%

sides

2-sided

lower limit

-118

upper limit

104.5

Variability estimate

Standard error of the mean

Dispersion value

56.7

Secondary: Urine Interleukin-18 (IL-18): Change from Baseline to Day 90

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End point title

Urine Interleukin-18 (IL-18): Change from Baseline to Day 90

End point description

From repeated measures analysis. The least squares mean (LS mean) change from baseline to each visit in urine IL-18 (pg/mL). Lower measures for IL-18 are desirable. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	43	47	44	36
Units: pg/mL
least squares mean (standard error)	1.7 ± 16.7	1.1 ± 15.9	6.3 ± 16.5	-2.7 ± 18.2

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-45.9

upper limit

44.6

Variability estimate

Standard error of the mean

Dispersion value

23.1

Statistical Analysis 2

Statistical analysis description

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

4.6

Confidence interval

level

95%

sides

2-sided

lower limit

-41.7

upper limit

50.8

Variability estimate

Standard error of the mean

Dispersion value

23.6

Statistical Analysis 3

Statistical analysis description

Comparison groups

Placebo v ABT-719 2100 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-4.4

Confidence interval

level

95%

sides

2-sided

lower limit

-53

upper limit

44.2

Variability estimate

Standard error of the mean

Dispersion value

24.8

Secondary: Urine Kidney Injury Molecule (KIM-1): Change from Baseline to Day 90

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End point title

Urine Kidney Injury Molecule (KIM-1): Change from Baseline to Day 90

End point description

From repeated measures analysis. The least squares mean (LS mean) change from baseline to each visit in urine KIM-1 (ng/mL). Lower measures for urine KIM-1 are desirable. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	43	47	44	36
Units: ng/mL
least squares mean (standard error)	0.17 ± 0.27	0.2 ± 0.25	-0.02 ± 0.26	0.36 ± 0.29

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-0.69

upper limit

0.74

Variability estimate

Standard error of the mean

Dispersion value

0.37

Statistical Analysis 2

Statistical analysis description

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.93

upper limit

0.54

Variability estimate

Standard error of the mean

Dispersion value

0.38

Statistical Analysis 3

Statistical analysis description

Comparison groups

Placebo v ABT-719 2100 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

0.19

Confidence interval

level

95%

sides

2-sided

lower limit

-0.58

upper limit

0.96

Variability estimate

Standard error of the mean

Dispersion value

0.4

Secondary: Urine Neutrophil Gelatinase Associated Lipocalin (NGAL): Change from Baseline to Day 90

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End point title

Urine Neutrophil Gelatinase Associated Lipocalin (NGAL): Change from Baseline to Day 90

End point description

From repeated measures analysis. The least squares mean (LS mean) change from baseline to each visit in NGAL (ng/mL). Lower measures for NGAL are desirable. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	43	47	44	36
Units: ng/mL
least squares mean (standard error)	399 ± 107.3	47 ± 103.7	18 ± 106.9	1 ± 118.2

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-352.3

Confidence interval

level

95%

sides

2-sided

lower limit

-645

upper limit

-60

Variability estimate

Standard error of the mean

Dispersion value

149.1

Statistical Analysis 2

Statistical analysis description

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-381.5

Confidence interval

level

95%

sides

2-sided

lower limit

-679

upper limit

-84

Variability estimate

Standard error of the mean

Dispersion value

151.54

Statistical Analysis 3

Statistical analysis description

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-389.7

Confidence interval

level

95%

sides

2-sided

lower limit

-711

upper limit

-86

Variability estimate

Standard error of the mean

Dispersion value

159.4

Secondary: Hospitalization Days Within 90 Days after Surgery

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End point title

Hospitalization Days Within 90 Days after Surgery

End point description

From ANOVA model. The LS mean number of days that subjects spent hospitalized, up to 90 days after surgery. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	51	54	55	49
Units: days
least squares mean (standard error)	19 ± 3.4	16.5 ± 3.3	12.2 ± 3.3	26.4 ± 3.5

Statistical Analysis 1

Statistical analysis description

ANOVA model with treatment as the factor.

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

105

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-2.4

Confidence interval

level

95%

sides

2-sided

lower limit

-10.2

upper limit

5.3

Variability estimate

Standard error of the mean

Dispersion value

4.7

Statistical Analysis 2

Statistical analysis description

ANOVA model with treatment as the factor.

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

106

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-6.8

Confidence interval

level

95%

sides

2-sided

lower limit

-14.5

upper limit

0.9

Variability estimate

Standard error of the mean

Dispersion value

4.7

Statistical Analysis 3

Statistical analysis description

ANOVA model with treatment as the factor.

Comparison groups

Placebo v ABT-719 2100 mcg/kg

Number of subjects included in analysis

100

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

7.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

15.4

Variability estimate

Standard error of the mean

Dispersion value

4.8

Secondary: Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Risk, Injury and Failure (RIFLE) Scoring Criteria

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End point title

Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Risk, Injury and Failure (RIFLE) Scoring Criteria

End point description

The RIFLE is an evidence-based definition for AKI based on changes to serum creatinine (SCr), urine output (UO), and two clinical outcomes (Loss [acute kidney failure for > 4 weeks] and End-stage renal disease). The 3 severity grades are defined on the basis of the changes in SCr or UO where the worst of each criterion is used: Risk (increased Cr x 1.5 or GFR decreased < 25%; UO < 0.5 mL/kg/hr x 6 hr), Injury (increased Cr x 2 or GFR decreased < 50%; UO < 0.5 mL/kg/hr x 12 hr), and Failure (increased Cr x 3 or GFR decreased < 25% or Cr ≥ 4 mg/dL with acute rise of ≥ 0.5 mg/dL; UO < 0.3 mL/kg/hr x 24 hr or anuria x 12 hr). The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 7

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	52	54	55	49
Units: percentage of subjects
number (not applicable)
No	26.92	25.93	32.73	22.45
Risk	11.54	14.81	9.09	18.37
Injury	51.92	53.7	52.73	53.06
Failure	9.62	5.56	5.45	6.12
Any stage	73.08	74.07	67.27	77.55

No statistical analyses for this end point

Secondary: Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Kidney Disease: Improving Global Outcomes (KDIGO) Scoring Criteria

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End point title

Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Kidney Disease: Improving Global Outcomes (KDIGO) Scoring Criteria

End point description

The KDIGO is based on the RIFLE and the AKIN criteria and risk relationships. AKI is defined as increase in SCr by ≥ 3 mg/dl (≥ 26.5 µmol/L) within 48 hours; increase in SCr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume < 0.5 mL/kg/h for 6 hours. The 3 severity grades are defined as: Stage 1 (increased Cr x 1.5-1.9 x baseline or ≥ 3 mg/dl [≥ 26.5 µmol/L] UO < 0.5 mL/kg/hr x 6-12 hr), Stage 2 (increased Cr x 2.0-2.9; UO < 0.5 mL/kg/hr x 12 hr), and Stage 3 (increased Cr x 3.0 OR increase Cr to ≥ 4.0 mg/dL (≥ 353.6 μmol/L) OR initiation of renal replacement therapy OR, in patients < 18 years, decrease in eGFR to < 35 mL/min per 1.73 m^2; UO < 0.3 mL/kg/hr for ≥ 24 hr or anuria for ≥ 12 hr). The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 7

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	52	54	55	49
Units: percentage of subjects
number (not applicable)
No	26.92	25.93	34.55	26.53
Stage 1	11.54	18.52	7.27	14.29
Stage 2	51.92	50	52.73	53.06
Stage 3	9.62	5.56	5.45	6.12
Any stage	73.08	74.07	65.45	73.47

No statistical analyses for this end point

Secondary: Serum Creatinine (SCr): Change from Baseline to Day 90

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End point title

Serum Creatinine (SCr): Change from Baseline to Day 90

End point description

From repeated measures analysis. The least squares mean (LS mean) change from baseline to each visit in SCr (µmol/L). Lower measures for SCr are desirable. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Baseline (Day 0) through Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	42	47	48	35
Units: µmol/L
least squares mean (standard error)	10.9 ± 3.54	9.3 ± 3.37	3.4 ± 3.38	6.5 ± 3.85

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-11.2

upper limit

Variability estimate

Standard error of the mean

Dispersion value

4.89

Statistical Analysis 2

Statistical analysis description

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-7.5

Confidence interval

level

95%

sides

2-sided

lower limit

-17.2

upper limit

2.1

Variability estimate

Standard error of the mean

Dispersion value

4.9

Statistical Analysis 3

Statistical analysis description

Comparison groups

Placebo v ABT-719 2100 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-4.3

Confidence interval

level

95%

sides

2-sided

lower limit

-14.6

upper limit

Variability estimate

Standard error of the mean

Dispersion value

5.25

Secondary: Serum Creatinine (SCr): Maximal Change from Baseline Over All Study Visits up to Day 7 (or Hospital Discharge)

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End point title

Serum Creatinine (SCr): Maximal Change from Baseline Over All Study Visits up to Day 7 (or Hospital Discharge)

End point description

From ANCOVA model. The least squares mean (LS mean) maximal change from baseline to each visit up to Day 7 in SCr (µmol/L). Lower measures for SCr are desirable. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Baseline (Day 0) through Day 7

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	51	54	50	48
Units: µmol/L
least squares mean (standard error)	30.2 ± 6.08	32.8 ± 5.9	26.3 ± 6.14	28.4 ± 6.26

Statistical Analysis 1

Statistical analysis description

ANCOVA model with treatment group as the factor and baseline as a covariate.

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

105

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-14

upper limit

19.3

Variability estimate

Standard error of the mean

Dispersion value

8.47

Statistical Analysis 2

Statistical analysis description

ANCOVA model with treatment group as the factor and baseline as a covariate.

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

101

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-3.9

Confidence interval

level

95%

sides

2-sided

lower limit

-20.9

upper limit

13.1

Variability estimate

Standard error of the mean

Dispersion value

8.64

Statistical Analysis 3

Statistical analysis description

ANCOVA model with treatment group as the factor and baseline as a covariate.

Comparison groups

Placebo v ABT-719 2100 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-19

upper limit

15.4

Variability estimate

Standard error of the mean

Dispersion value

8.73

Secondary: S-Cystatin C: Change from Baseline to Day 90

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End point title

S-Cystatin C: Change from Baseline to Day 90

End point description

From repeated measures analysis. The least squares mean (LS mean) change from baseline to each visit in S-Cystatin C (nmol/L). Lower measures for S-Cystatin C are desirable. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	40	47	46	35
Units: nmol/L
least squares mean (standard error)	16.1 ± 3.13	11.3 ± 2.96	11.6 ± 3.03	12.8 ± 3.34

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-4.7

Confidence interval

level

95%

sides

2-sided

lower limit

-13.2

upper limit

3.7

Variability estimate

Standard error of the mean

Dispersion value

4.31

Statistical Analysis 2

Statistical analysis description

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-4.5

Confidence interval

level

95%

sides

2-sided

lower limit

-13.1

upper limit

4.1

Variability estimate

Standard error of the mean

Dispersion value

4.36

Statistical Analysis 3

Statistical analysis description

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-3.3

Confidence interval

level

95%

sides

2-sided

lower limit

-12.3

upper limit

5.7

Variability estimate

Standard error of the mean

Dispersion value

4.58

Secondary: S-Cystatin C: Maximal Change from Baseline Over All Study Visits up to Day 7 (or Hospital Discharge)

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End point title

S-Cystatin C: Maximal Change from Baseline Over All Study Visits up to Day 7 (or Hospital Discharge)

End point description

From ANCOVA model. The least squares mean (LS mean) maximal change from baseline to each visit up to Day 7 in S-Cystatin C (nmol/L). Lower measures for S-Cystatin C are desirable. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Baseline (Day 0) through Day 7

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	51	54	50	48
Units: µmol/L
least squares mean (standard error)	22.6 ± 4.04	23 ± 3.92	18.4 ± 4.08	20.6 ± 4.16

Statistical Analysis 1

Statistical analysis description

ANCOVA model with treatment group as the factor and baseline as a covariate.

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

105

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-10.6

upper limit

11.5

Variability estimate

Standard error of the mean

Dispersion value

5.63

Statistical Analysis 2

Statistical analysis description

ANCOVA model with treatment group as the factor and baseline as a covariate.

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

101

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-4.1

Confidence interval

level

95%

sides

2-sided

lower limit

-15.4

upper limit

7.2

Variability estimate

Standard error of the mean

Dispersion value

5.74

Statistical Analysis 3

Statistical analysis description

ANCOVA model with treatment group as the factor and baseline as a covariate.

Comparison groups

Placebo v ABT-719 2100 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-13.4

upper limit

9.4

Variability estimate

Standard error of the mean

Dispersion value

5.8

Secondary: Measured Glomerular Filtration Rate (GFR): Change from Baseline to Day 90

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End point title

Measured Glomerular Filtration Rate (GFR): Change from Baseline to Day 90

End point description

From repeated measures analysis. The least squares mean (LS mean) change from baseline to each visit in GFR (L/min/1.73m^2). Higher measures for GFR are desirable. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Baseline (Day 0) through Day 7

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	42	45	48	35
Units: mL/min/1.73m^2
least squares mean (standard error)	-4 ± 1.72	-4.9 ± 1.67	-1.2 ± 1.67	-5.9 ± 1.86

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-5.6

upper limit

3.8

Variability estimate

Standard error of the mean

Dispersion value

2.41

Statistical Analysis 2

Statistical analysis description

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1.9

upper limit

7.5

Variability estimate

Standard error of the mean

Dispersion value

2.4

Statistical Analysis 3

Statistical analysis description

Comparison groups

Placebo v ABT-719 2100 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-6.9

upper limit

3.1

Variability estimate

Standard error of the mean

Dispersion value

2.54

Secondary: Estimated Glomerular Filtration Rate (eGFR): Change from Baseline to Day 90

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End point title

Estimated Glomerular Filtration Rate (eGFR): Change from Baseline to Day 90

End point description

From repeated measures analysis. The least squares mean (LS mean) change from baseline to each visit in eGFR (L/min/1.73m^2). Higher measures for eGFR are desirable. All subjects in the per protocol analysis set with available data are included in the analysis.

End point type

Secondary

End point timeframe

Baseline (Day 0) through Day 7

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	7	6	7	4
Units: mL/min/1.73m^2
least squares mean (standard error)	-11.1 ± 5.04	-6.6 ± 5.13	2.3 ± 4.9	2.7 ± 6.46

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

4.5

Confidence interval

level

95%

sides

2-sided

lower limit

-10.2

upper limit

19.2

Variability estimate

Standard error of the mean

Dispersion value

7.27

Statistical Analysis 2

Statistical analysis description

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

13.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

27.8

Variability estimate

Standard error of the mean

Dispersion value

7.11

Statistical Analysis 3

Statistical analysis description

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

13.8

Confidence interval

level

95%

sides

2-sided

lower limit

-2.7

upper limit

30.3

Variability estimate

Standard error of the mean

Dispersion value

8.15

Secondary: Intensive Care Unit (ICU) Days Within 90 Days after Surgery

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End point title

Intensive Care Unit (ICU) Days Within 90 Days after Surgery

End point description

From ANOVA model. The LS mean number of days that subjects spent in ICU, up to 90 days after surgery. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Secondary

End point timeframe

Day 0 (Surgery) to Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	49	51	54	49
Units: days
least squares mean (standard error)	5.4 ± 0.8	4.6 ± 0.8	3.5 ± 0.8	6.3 ± 0.8

Statistical Analysis 1

Statistical analysis description

ANOVA model with treatment as the factor.

Comparison groups

Placebo v ABT-719 800 mcg/kg

Number of subjects included in analysis

100

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-2.8

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.1

Statistical Analysis 2

Statistical analysis description

ANOVA model with treatment as the factor.

Comparison groups

Placebo v ABT-719 1600 mcg/kg

Number of subjects included in analysis

103

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3.8

upper limit

-0.1

Variability estimate

Standard error of the mean

Dispersion value

1.1

Statistical Analysis 3

Statistical analysis description

ANOVA model with treatment as the factor.

Comparison groups

Placebo v ABT-719 2100 mcg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean of difference

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

2.7

Variability estimate

Standard error of the mean

Dispersion value

1.2

Other pre-specified: Euroqol 5 Dimensions Questionnaire (EQ-5D) Index: Change from Baseline to Day 90

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End point title

Euroqol 5 Dimensions Questionnaire (EQ-5D) Index: Change from Baseline to Day 90

End point description

The EQ-5D-3L consists of 5 dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, and 5) anxiety/depression. There are 3 levels to each dimension; Level 1 = no problem, Level 2 = some problem, and Level 3 = extreme problem. The scores of the 5 dimensions were converted into a single summary index by utilizing country specific value sets. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Other pre-specified

End point timeframe

Day 0 (Surgery) and Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	46	49	52	38
Units: units on a scale
arithmetic mean (standard deviation)	0.034 ± 0.092	0.072 ± 0.1	0.017 ± 0.093	0.017 ± 0.102

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Who Experienced "No Problem" (Level 1) and "Problems" (Levels 2 and 3) in the 5 Dimensions of the Euroqol 5 Dimensions (EQ-5D) Questionnaire on Day 90

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End point title

Percentage of Subjects Who Experienced "No Problem" (Level 1) and "Problems" (Levels 2 and 3) in the 5 Dimensions of the Euroqol 5 Dimensions (EQ-5D) Questionnaire on Day 90

End point description

The EQ-5D-3L consists of 5 dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, and 5) anxiety/depression. There are 3 levels to each dimension; Level 1 = no problem, Level 2 = some problem, and Level 3 = extreme problem. All subjects in the per protocol analysis set with available data are included in the analysis. The number of subjects analyzed = all subjects in the per protocol analysis set with available data.

End point type

Other pre-specified

End point timeframe

Day 90

End point values	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Number of subjects analysed	46	49	53	38
Units: percentage of subjects
number (not applicable)
Mobility - no problem	73.91	85.71	69.81	76.32
Mobility - some problem	26.09	14.29	30.19	23.68
Mobility - extreme problem	0	0	0	0
Self-care - no problem	93.48	95.92	90.57	94.74
Self-care - some problem	6.52	4.08	9.43	5.26
Self-care - extreme problem	0	0	0	0
Usual activities - no problem	63.04	83.67	60.38	71.05
Usual activities - some problem	34.78	16.33	35.85	28.95
Usual activities - extreme problem	2.17	0	3.77	0
Pain/discomfort - no problem	71.74	77.55	67.92	73.68
Pain/discomfort - some problem	23.91	22.45	26.42	26.32
Pain/discomfort - extreme problem	4.35	0	5.66	0
Anxiety/depression - no problem	84.78	91.84	77.36	84.21
Anxiety/depression - some problem	15.22	8.16	22.64	10.53
Anxiety/depression - extreme problem	0	0	0	5.26

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events (AEs) were collected from study drug administration until 30 days after last dose (32 days); serious adverse events (SAEs) were collected from the time that informed consent was obtained (60 days).

Adverse event reporting additional description

AEs were collected whether solicited or spontaneously reported by the subject until 30 days after last dose; after 30 days, only AEs that were spontaneously reported were collected.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

Reporting group title

Placebo

Reporting group description

Reporting group title

ABT-719 800 mcg/kg

Reporting group description

Reporting group title

ABT-719 1600 mcg/kg

Reporting group description

Reporting group title

ABT-719 2100 mcg/kg

Reporting group description

Serious adverse events	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Total subjects affected by serious adverse events
subjects affected / exposed	26 / 59 (44.07%)	12 / 57 (21.05%)	13 / 59 (22.03%)	27 / 56 (48.21%)
number of deaths (all causes)	3	1	0	4
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhage
subjects affected / exposed	2 / 59 (3.39%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Hypoperfusion
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypotension
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	1 / 59 (1.69%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subclavian vein thrombosis
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Multi-organ failure
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea paroxysmal nocturnal
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 59 (1.69%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	2 / 59 (3.39%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	3 / 59 (5.08%)	1 / 57 (1.75%)	0 / 59 (0.00%)	5 / 56 (8.93%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
Psychiatric disorders
Mental status changes
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Escherichia test positive
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Heart rate decreased
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulse absent
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Cardiac valve rupture
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Fall
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative thoracic procedure complication
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	1 / 59 (1.69%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Procedural haemorrhage
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Venous injury
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Aortic valve incompetence
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	1 / 59 (1.69%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	5 / 59 (8.47%)	1 / 57 (1.75%)	0 / 59 (0.00%)	4 / 56 (7.14%)
occurrences causally related to treatment / all	0 / 5	0 / 1	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	1 / 59 (1.69%)	1 / 57 (1.75%)	1 / 59 (1.69%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrioventricular dissociation
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	2 / 59 (3.39%)	2 / 57 (3.51%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	3 / 59 (5.08%)	0 / 57 (0.00%)	1 / 59 (1.69%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiogenic shock
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	2 / 56 (3.57%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial haemorrhage
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	1 / 59 (1.69%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pericardial haemorrhage
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulseless electrical activity
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	2 / 56 (3.57%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Supraventricular tachycardia
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ventricle rupture
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebral infarction
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	2 / 59 (3.39%)	1 / 57 (1.75%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Convulsion
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dizziness
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	1 / 59 (1.69%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Coagulopathy
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Heparin-induced thrombocytopenia
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal compartment syndrome
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	1 / 59 (1.69%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatic ischaemia
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Decubitus ulcer
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Renal disorder
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	1 / 59 (1.69%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure acute
subjects affected / exposed	3 / 59 (5.08%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure chronic
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Critical illness myopathy
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Diverticulitis
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Mediastinitis
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 59 (1.69%)	0 / 57 (0.00%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia klebsiella
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Wound infection
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fluid overload
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	0 / 59 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo	ABT-719 800 mcg/kg	ABT-719 1600 mcg/kg	ABT-719 2100 mcg/kg
Total subjects affected by non serious adverse events
subjects affected / exposed	54 / 59 (91.53%)	42 / 57 (73.68%)	54 / 59 (91.53%)	49 / 56 (87.50%)
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	0 / 59 (0.00%)	3 / 57 (5.26%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	3	0	1
Hypertension
subjects affected / exposed	2 / 59 (3.39%)	6 / 57 (10.53%)	2 / 59 (3.39%)	6 / 56 (10.71%)
occurrences all number	2	6	2	6
Hypotension
subjects affected / exposed	8 / 59 (13.56%)	7 / 57 (12.28%)	11 / 59 (18.64%)	11 / 56 (19.64%)
occurrences all number	9	8	11	12
General disorders and administration site conditions
Fatigue
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	3 / 59 (5.08%)	2 / 56 (3.57%)
occurrences all number	0	1	3	2
Oedema
subjects affected / exposed	2 / 59 (3.39%)	3 / 57 (5.26%)	2 / 59 (3.39%)	3 / 56 (5.36%)
occurrences all number	2	3	2	3
Oedema peripheral
subjects affected / exposed	3 / 59 (5.08%)	3 / 57 (5.26%)	3 / 59 (5.08%)	3 / 56 (5.36%)
occurrences all number	3	3	3	3
Pain
subjects affected / exposed	6 / 59 (10.17%)	3 / 57 (5.26%)	7 / 59 (11.86%)	7 / 56 (12.50%)
occurrences all number	7	3	7	7
Pyrexia
subjects affected / exposed	2 / 59 (3.39%)	3 / 57 (5.26%)	5 / 59 (8.47%)	4 / 56 (7.14%)
occurrences all number	2	3	6	4
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	1 / 59 (1.69%)	3 / 57 (5.26%)	2 / 59 (3.39%)	0 / 56 (0.00%)
occurrences all number	1	3	2	0
Atelectasis
subjects affected / exposed	6 / 59 (10.17%)	9 / 57 (15.79%)	10 / 59 (16.95%)	6 / 56 (10.71%)
occurrences all number	6	9	10	8
Dyspnoea
subjects affected / exposed	3 / 59 (5.08%)	2 / 57 (3.51%)	1 / 59 (1.69%)	2 / 56 (3.57%)
occurrences all number	3	2	1	2
Pleural effusion
subjects affected / exposed	18 / 59 (30.51%)	10 / 57 (17.54%)	13 / 59 (22.03%)	13 / 56 (23.21%)
occurrences all number	19	11	13	15
Pneumothorax
subjects affected / exposed	1 / 59 (1.69%)	3 / 57 (5.26%)	2 / 59 (3.39%)	3 / 56 (5.36%)
occurrences all number	1	3	2	3
Respiratory failure
subjects affected / exposed	2 / 59 (3.39%)	3 / 57 (5.26%)	4 / 59 (6.78%)	5 / 56 (8.93%)
occurrences all number	2	3	4	5
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 59 (0.00%)	2 / 57 (3.51%)	3 / 59 (5.08%)	4 / 56 (7.14%)
occurrences all number	0	2	3	4
Confusional state
subjects affected / exposed	3 / 59 (5.08%)	1 / 57 (1.75%)	2 / 59 (3.39%)	3 / 56 (5.36%)
occurrences all number	3	1	2	3
Delirium
subjects affected / exposed	1 / 59 (1.69%)	3 / 57 (5.26%)	1 / 59 (1.69%)	2 / 56 (3.57%)
occurrences all number	1	3	1	2
Insomnia
subjects affected / exposed	4 / 59 (6.78%)	2 / 57 (3.51%)	2 / 59 (3.39%)	2 / 56 (3.57%)
occurrences all number	4	2	2	2
Mental status changes
subjects affected / exposed	1 / 59 (1.69%)	3 / 57 (5.26%)	0 / 59 (0.00%)	2 / 56 (3.57%)
occurrences all number	1	3	0	2
Investigations
Blood creatinine increased
subjects affected / exposed	4 / 59 (6.78%)	0 / 57 (0.00%)	2 / 59 (3.39%)	3 / 56 (5.36%)
occurrences all number	4	0	2	3
Cardiac index decreased
subjects affected / exposed	1 / 59 (1.69%)	3 / 57 (5.26%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences all number	1	3	0	1
Urine output decreased
subjects affected / exposed	3 / 59 (5.08%)	1 / 57 (1.75%)	7 / 59 (11.86%)	4 / 56 (7.14%)
occurrences all number	3	1	7	4
Injury, poisoning and procedural complications
Anaemia postoperative
subjects affected / exposed	1 / 59 (1.69%)	1 / 57 (1.75%)	1 / 59 (1.69%)	4 / 56 (7.14%)
occurrences all number	1	1	1	4
Incision site pain
subjects affected / exposed	6 / 59 (10.17%)	5 / 57 (8.77%)	5 / 59 (8.47%)	5 / 56 (8.93%)
occurrences all number	7	5	5	5
Procedural haemorrhage
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	3 / 59 (5.08%)	1 / 56 (1.79%)
occurrences all number	0	0	3	1
Procedural nausea
subjects affected / exposed	6 / 59 (10.17%)	8 / 57 (14.04%)	6 / 59 (10.17%)	9 / 56 (16.07%)
occurrences all number	6	8	6	9
Procedural pain
subjects affected / exposed	22 / 59 (37.29%)	19 / 57 (33.33%)	20 / 59 (33.90%)	23 / 56 (41.07%)
occurrences all number	22	19	20	23
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	25 / 59 (42.37%)	17 / 57 (29.82%)	13 / 59 (22.03%)	21 / 56 (37.50%)
occurrences all number	27	17	14	21
Atrial flutter
subjects affected / exposed	2 / 59 (3.39%)	1 / 57 (1.75%)	0 / 59 (0.00%)	4 / 56 (7.14%)
occurrences all number	2	1	0	4
Sinus tachycardia
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	4 / 59 (6.78%)	0 / 56 (0.00%)
occurrences all number	0	0	4	0
Tachycardia
subjects affected / exposed	1 / 59 (1.69%)	2 / 57 (3.51%)	1 / 59 (1.69%)	3 / 56 (5.36%)
occurrences all number	1	2	1	3
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	16 / 59 (27.12%)	12 / 57 (21.05%)	20 / 59 (33.90%)	12 / 56 (21.43%)
occurrences all number	16	12	20	12
Haemorrhagic anaemia
subjects affected / exposed	2 / 59 (3.39%)	0 / 57 (0.00%)	8 / 59 (13.56%)	0 / 56 (0.00%)
occurrences all number	2	0	8	0
Leukocytosis
subjects affected / exposed	4 / 59 (6.78%)	3 / 57 (5.26%)	2 / 59 (3.39%)	5 / 56 (8.93%)
occurrences all number	4	3	3	5
Thrombocytopenia
subjects affected / exposed	6 / 59 (10.17%)	8 / 57 (14.04%)	9 / 59 (15.25%)	4 / 56 (7.14%)
occurrences all number	6	8	9	5
Gastrointestinal disorders
Constipation
subjects affected / exposed	16 / 59 (27.12%)	10 / 57 (17.54%)	14 / 59 (23.73%)	15 / 56 (26.79%)
occurrences all number	17	10	14	15
Diarrhoea
subjects affected / exposed	0 / 59 (0.00%)	0 / 57 (0.00%)	2 / 59 (3.39%)	3 / 56 (5.36%)
occurrences all number	0	0	2	3
Dysphagia
subjects affected / exposed	1 / 59 (1.69%)	3 / 57 (5.26%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences all number	1	3	1	1
Nausea
subjects affected / exposed	19 / 59 (32.20%)	13 / 57 (22.81%)	22 / 59 (37.29%)	19 / 56 (33.93%)
occurrences all number	21	13	23	19
Vomiting
subjects affected / exposed	3 / 59 (5.08%)	3 / 57 (5.26%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences all number	4	3	1	1
Renal and urinary disorders
Renal failure
subjects affected / exposed	1 / 59 (1.69%)	1 / 57 (1.75%)	1 / 59 (1.69%)	3 / 56 (5.36%)
occurrences all number	1	1	1	3
Renal failure acute
subjects affected / exposed	3 / 59 (5.08%)	2 / 57 (3.51%)	2 / 59 (3.39%)	3 / 56 (5.36%)
occurrences all number	3	2	2	3
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
subjects affected / exposed	3 / 59 (5.08%)	1 / 57 (1.75%)	1 / 59 (1.69%)	1 / 56 (1.79%)
occurrences all number	3	1	1	1
Infections and infestations
Urinary tract infection
subjects affected / exposed	3 / 59 (5.08%)	2 / 57 (3.51%)	0 / 59 (0.00%)	1 / 56 (1.79%)
occurrences all number	3	2	0	1
Metabolism and nutrition disorders
Acidosis
subjects affected / exposed	3 / 59 (5.08%)	2 / 57 (3.51%)	5 / 59 (8.47%)	3 / 56 (5.36%)
occurrences all number	3	2	5	3
Electrolyte imbalance
subjects affected / exposed	2 / 59 (3.39%)	0 / 57 (0.00%)	3 / 59 (5.08%)	3 / 56 (5.36%)
occurrences all number	2	0	3	3
Fluid overload
subjects affected / exposed	10 / 59 (16.95%)	10 / 57 (17.54%)	19 / 59 (32.20%)	9 / 56 (16.07%)
occurrences all number	10	10	20	9
Fluid retention
subjects affected / exposed	2 / 59 (3.39%)	3 / 57 (5.26%)	2 / 59 (3.39%)	1 / 56 (1.79%)
occurrences all number	2	3	2	1
Hyperglycaemia
subjects affected / exposed	15 / 59 (25.42%)	10 / 57 (17.54%)	15 / 59 (25.42%)	17 / 56 (30.36%)
occurrences all number	15	10	15	17
Hypoalbuminaemia
subjects affected / exposed	0 / 59 (0.00%)	1 / 57 (1.75%)	2 / 59 (3.39%)	3 / 56 (5.36%)
occurrences all number	0	1	2	3
Hypocalcaemia
subjects affected / exposed	6 / 59 (10.17%)	5 / 57 (8.77%)	12 / 59 (20.34%)	9 / 56 (16.07%)
occurrences all number	6	5	12	10
Hypokalaemia
subjects affected / exposed	14 / 59 (23.73%)	14 / 57 (24.56%)	16 / 59 (27.12%)	14 / 56 (25.00%)
occurrences all number	16	14	16	14
Hypomagnesaemia
subjects affected / exposed	6 / 59 (10.17%)	4 / 57 (7.02%)	9 / 59 (15.25%)	5 / 56 (8.93%)
occurrences all number	6	4	9	5
Hyponatraemia
subjects affected / exposed	2 / 59 (3.39%)	2 / 57 (3.51%)	3 / 59 (5.08%)	2 / 56 (3.57%)
occurrences all number	2	2	3	2
Hypovolaemia
subjects affected / exposed	3 / 59 (5.08%)	2 / 57 (3.51%)	3 / 59 (5.08%)	3 / 56 (5.36%)
occurrences all number	3	2	3	3
Metabolic acidosis
subjects affected / exposed	5 / 59 (8.47%)	2 / 57 (3.51%)	3 / 59 (5.08%)	0 / 56 (0.00%)
occurrences all number	5	2	3	0

More information

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Were there any global substantial amendments to the protocol? Yes

04 Dec 2012

To remove both 1200 mcg/kg groups and add the 1600 mcg/kg and 2100 mcg/kg groups and update procedures and statistical analyses; for doses given outside the operating room, allow principal investigator to write an order for study drug to be administered by hospital personnel; permit an additional 20 subjects per treatment group if appropriate based on results from interim analysis; add that some of the study visits may be conducted in the home or in a non-hospital setting and that subjects may use a home trial support service with agreement of the investigatory; modify inclusion criteria to clarify the definition of stable renal function, that patients with intravascular iodinated contrast within 48 hours of the day of surgery could be included if no known serum creatinine change ≥0.3 mg; modify exclusion criteria to clarify definition of active peptic ulcer, exclude patients with known or document RIFLE ‘R’ or AKIN ‘Stage 1’ results within the previous 4 weeks; specify timing of urine output collection; add must specify need for RRT; clarify measurements and procedures; add secondary endpoints to evaluate composite events utilizing cystatin-C based eGFR in addition to SCr based eGFR; change number of infusions from 5 to 6 and, if study drug is administered through a central line, then it should be administered through a separate port; add 2 interim analyses; revise total of number of subjects to up to 240.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Acute Kidney Injury Network (AKIN) Scoring Criteria

Primary: Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Acute Kidney Injury Network (AKIN) Scoring Criteria

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 25% Reduction in Serum Creatinine Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 25% Reduction in Serum Creatinine Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 50% Reduction in Serum Creatinine Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 50% Reduction in Serum Creatinine Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 25% Reduction in S-Cystatin C Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 25% Reduction in S-Cystatin C Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 50% Reduction in S-Cystatin C Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

Secondary: Percentage of Subjects Developing a Composite Event (Death, Renal Replacement Therapy [RRT], or 50% Reduction in S-Cystatin C Based Estimated Glomerular Filtration Rate [SCr eGFR]) – Day 90

Secondary: Serum Neutrophil Gelatinase Associated Lipocalin (NGAL): Change from Baseline to Day 90

Secondary: Serum Neutrophil Gelatinase Associated Lipocalin (NGAL): Change from Baseline to Day 90

Secondary: Urine Interleukin-18 (IL-18): Change from Baseline to Day 90

Secondary: Urine Interleukin-18 (IL-18): Change from Baseline to Day 90

Secondary: Urine Kidney Injury Molecule (KIM-1): Change from Baseline to Day 90

Secondary: Urine Kidney Injury Molecule (KIM-1): Change from Baseline to Day 90

Secondary: Urine Neutrophil Gelatinase Associated Lipocalin (NGAL): Change from Baseline to Day 90

Secondary: Urine Neutrophil Gelatinase Associated Lipocalin (NGAL): Change from Baseline to Day 90

Secondary: Hospitalization Days Within 90 Days after Surgery

Secondary: Hospitalization Days Within 90 Days after Surgery

Secondary: Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Risk, Injury and Failure (RIFLE) Scoring Criteria

Secondary: Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Risk, Injury and Failure (RIFLE) Scoring Criteria

Secondary: Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Kidney Disease: Improving Global Outcomes (KDIGO) Scoring Criteria

Secondary: Percentage of Subjects Developing Acute Kidney Injury (AKI) as Defined by the Kidney Disease: Improving Global Outcomes (KDIGO) Scoring Criteria

Secondary: Serum Creatinine (SCr): Change from Baseline to Day 90

Secondary: Serum Creatinine (SCr): Change from Baseline to Day 90

Secondary: Serum Creatinine (SCr): Maximal Change from Baseline Over All Study Visits up to Day 7 (or Hospital Discharge)

Secondary: Serum Creatinine (SCr): Maximal Change from Baseline Over All Study Visits up to Day 7 (or Hospital Discharge)

Secondary: S-Cystatin C: Change from Baseline to Day 90

Secondary: S-Cystatin C: Change from Baseline to Day 90

Secondary: S-Cystatin C: Maximal Change from Baseline Over All Study Visits up to Day 7 (or Hospital Discharge)

Secondary: S-Cystatin C: Maximal Change from Baseline Over All Study Visits up to Day 7 (or Hospital Discharge)

Secondary: Measured Glomerular Filtration Rate (GFR): Change from Baseline to Day 90

Secondary: Measured Glomerular Filtration Rate (GFR): Change from Baseline to Day 90

Secondary: Estimated Glomerular Filtration Rate (eGFR): Change from Baseline to Day 90

Secondary: Estimated Glomerular Filtration Rate (eGFR): Change from Baseline to Day 90

Secondary: Intensive Care Unit (ICU) Days Within 90 Days after Surgery

Secondary: Intensive Care Unit (ICU) Days Within 90 Days after Surgery

Other pre-specified: Euroqol 5 Dimensions Questionnaire (EQ-5D) Index: Change from Baseline to Day 90

Other pre-specified: Euroqol 5 Dimensions Questionnaire (EQ-5D) Index: Change from Baseline to Day 90

Other pre-specified: Percentage of Subjects Who Experienced "No Problem" (Level 1) and "Problems" (Levels 2 and 3) in the 5 Dimensions of the Euroqol 5 Dimensions (EQ-5D) Questionnaire on Day 90

Other pre-specified: Percentage of Subjects Who Experienced "No Problem" (Level 1) and "Problems" (Levels 2 and 3) in the 5 Dimensions of the Euroqol 5 Dimensions (EQ-5D) Questionnaire on Day 90

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery