Trial Outcomes & Findings for Study of the Vascular Effects of Serelaxin (NCT NCT01979614)
NCT ID: NCT01979614
Last Updated: 2019-07-01
Results Overview
Global MPRI (Myocardial Perfusion Reserve Index) is defined as ratio between mean global myocardial blood flow values at rest and during adenosine stress with Mid Perfusion Reserve Index or Midl PRI (Mid Perfusion Reserve Index) which is defined as ratio between mid myocardial blood flow values at rest and during adenosine stress
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
baseline to Day 3
Results posted on
2019-07-01
Participant Flow
Out of the total 63 participants screened, 62 were randomized. 4 of the randomized participants did not receive study drug, and 58 did receive study drug
Of the 58 participants in the safety analysis set, 56 completed the treatment and follow-up period as planned (i.e. Day 30 and Day 180).
Participant milestones
| Measure |
Serelaxin
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
|
Overall Study
Safety Analysis Set
|
30
|
28
|
|
Overall Study
PK Analysis Set
|
30
|
0
|
|
Overall Study
PD Analysis Set
|
25
|
26
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Serelaxin
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
Study of the Vascular Effects of Serelaxin
Baseline characteristics by cohort
| Measure |
Serelaxin
n=30 Participants
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
n=28 Participants
Placebo was administered by intravenous infusion for 48 hours
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 Years
STANDARD_DEVIATION 6.42 • n=5 Participants
|
60.1 Years
STANDARD_DEVIATION 7.05 • n=7 Participants
|
61.4 Years
STANDARD_DEVIATION 6.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to Day 3Population: The Pharmacodynamic (PD) analysis set included all patients with available PD data who received any study drug and experienced no protocol deviations with relevant impact on PD data. Participants who did not receive study drug as per study protocol, i.e. a reduced infusion rate, were excluded from this analysis
Global MPRI (Myocardial Perfusion Reserve Index) is defined as ratio between mean global myocardial blood flow values at rest and during adenosine stress with Mid Perfusion Reserve Index or Midl PRI (Mid Perfusion Reserve Index) which is defined as ratio between mid myocardial blood flow values at rest and during adenosine stress
Outcome measures
| Measure |
Serelaxin
n=22 Participants
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
n=25 Participants
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Statistical Analysis of Change From Baseline to Day 3 in Myocardial Perfusion Endpoints Compared With Mid Perfusion Reserve Index Using ANCOVA End Points
Global Myocardial Perfusion Reserve Index (MPRI)
|
-0.244 ratio
Interval -0.454 to -0.035
|
-0.133 ratio
Interval -0.329 to -0.064
|
|
Statistical Analysis of Change From Baseline to Day 3 in Myocardial Perfusion Endpoints Compared With Mid Perfusion Reserve Index Using ANCOVA End Points
Mid Perfusion Reserve Index
|
-0.264 ratio
Interval -0.519 to -0.01
|
-0.075 ratio
Interval -0.313 to 0.164
|
SECONDARY outcome
Timeframe: At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusionPopulation: PD Analysis Set
Measurements of arterial stiffness from cardiac MRI - Mean (SD) \[n\] Aortic distensibility was assessed by MRI and pulse wave velocity using the SphygmoCor device. (mmHg-1)
Outcome measures
| Measure |
Serelaxin
n=25 Participants
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
n=26 Participants
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Change From Baseline in Aortic Distensibility Measured by MRI
Ascending Aorta Distensibility, Day 0
|
0.0017 mmHg-1
Standard Deviation 0.00158
|
0.0014 mmHg-1
Standard Deviation 0.00192
|
|
Change From Baseline in Aortic Distensibility Measured by MRI
Ascending Aorta Distensibility, Day 47
|
0.0015 mmHg-1
Standard Deviation 0.00124
|
0.0015 mmHg-1
Standard Deviation 0.00134
|
|
Change From Baseline in Aortic Distensibility Measured by MRI
Descending Aorta Distensibility, Day 0
|
0.0023 mmHg-1
Standard Deviation 0.00146
|
0.0019 mmHg-1
Standard Deviation 0.00221
|
|
Change From Baseline in Aortic Distensibility Measured by MRI
Descending Aorta Distensibility, Day 47
|
0.0023 mmHg-1
Standard Deviation 0.00118
|
0.0023 mmHg-1
Standard Deviation 0.00142
|
SECONDARY outcome
Timeframe: At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusionPopulation: PD Analysis Set
Summary table for measurements of arterial velocity from cardiac MRI - Mean (SD) \[n\] Aortic distensibility was assessed by MRI and pulse wave velocity using the SphygmoCor device
Outcome measures
| Measure |
Serelaxin
n=25 Participants
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
n=26 Participants
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Change From Baseline in Aortic Velocity
Peak Flow Velocity (cm/s), Day 0 (n=24, 24)
|
127.981 cm/s
Standard Deviation 60.7571
|
106.557 cm/s
Standard Deviation 38.9573
|
|
Change From Baseline in Aortic Velocity
Peak Flow Velocity (cm/s), Day 47 (n=23, 25)
|
127.981 cm/s
Standard Deviation 60.7571
|
106.557 cm/s
Standard Deviation 38.9573
|
SECONDARY outcome
Timeframe: Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusionPopulation: PD Analysis Set For analysis of change from baseline, only subjects with results at both baseline and post-baseline could be included
Summary of values and change from baseline in augmentation index by time and treatment The change from baseline in Augmentation Index was analyzed using a repeated measures analysis of covariance including treatment, time, treatment by time, baseline by time interactions and baseline as fixed factors with an unstructured variance-covariance matrixStatistical analysis of change from baseline in augmentation index using repeated measures Analysis of Covariance
Outcome measures
| Measure |
Serelaxin
n=25 Participants
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
n=26 Participants
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Change From Baseline in Augmentation Index Measured From Sphygmocor Device
DAY 1, 6h (n=24,26)
|
-2.99 ratio
Standard Deviation 9.066
|
-0.58 ratio
Standard Deviation 9.551
|
|
Change From Baseline in Augmentation Index Measured From Sphygmocor Device
DAY 2, 24h (n=24,25)
|
-0.82 ratio
Standard Deviation 8.173
|
0.22 ratio
Standard Deviation 9.906
|
|
Change From Baseline in Augmentation Index Measured From Sphygmocor Device
DAY 1, 2h (n=23,25)
|
-4.12 ratio
Standard Deviation 11.441
|
-2.48 ratio
Standard Deviation 11.560
|
|
Change From Baseline in Augmentation Index Measured From Sphygmocor Device
DAY 3, 47h (n=23,25)
|
3.51 ratio
Standard Deviation 10.608
|
0.22 ratio
Standard Deviation 12.057
|
|
Change From Baseline in Augmentation Index Measured From Sphygmocor Device
DAY 3, 50h (n=22, 24)
|
-0.67 ratio
Standard Deviation 13.034
|
-3.81 ratio
Standard Deviation 9.397
|
|
Change From Baseline in Augmentation Index Measured From Sphygmocor Device
DAY 3, 54h (n=22,25)
|
-1.37 ratio
Standard Deviation 12.253
|
-0.48 ratio
Standard Deviation 11.748
|
|
Change From Baseline in Augmentation Index Measured From Sphygmocor Device
DAY 30 (n=25, 26)
|
-0.83 ratio
Standard Deviation 11.462
|
0.58 ratio
Standard Deviation 12.124
|
|
Change From Baseline in Augmentation Index Measured From Sphygmocor Device
DAY 180 (n=24,25) end of study
|
0.24 ratio
Standard Deviation 6.885
|
0.54 ratio
Standard Deviation 11.795
|
SECONDARY outcome
Timeframe: Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusionPopulation: PD Analysis Set
The change from baseline in Augmentation Index was analyzed using a repeated measures analysis of covariance including treatment, time, treatment by time, baseline by time interactions and baseline as fixed factors with an unstructured variance-covariance matrixStatistical analysis of change from baseline in augmentation index using repeated measures Analysis of Covariance For analysis of change from baseline, only subjects with results at both baseline and post-baseline could be included The augmentation index is a ratio calculated from the blood pressure waveform, it is a measure of wave reflection and arterial stiffness. Augmentation index is commonly accepted as a measure of the enhancement (augmentation) of central aortic pressure by a reflected pulse wave
Outcome measures
| Measure |
Serelaxin
n=25 Participants
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
n=26 Participants
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance
DAY 30 (n=25, 26)
|
-0.979 ratio
Interval -4.912 to 2.954
|
0.776 ratio
Interval -3.081 to 4.633
|
|
Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance
DAY 1, 2h (n=23,25)
|
-4.088 ratio
Interval -7.967 to -0.21
|
-1.970 ratio
Interval -5.693 to 1.753
|
|
Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance
DAY 1, 6h (n=24,26)
|
-3.277 ratio
Interval -6.129 to -0.425
|
-0.394 ratio
Interval -3.139 to 2.352
|
|
Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance
DAY 2, 24h (n=24,25)
|
-0.774 ratio
Interval -4.016 to 2.469
|
0.070 ratio
Interval -3.108 to 3.247
|
|
Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance
DAY 3, 47h (n=23,25)
|
3.488 ratio
Interval -0.47 to 7.445
|
0.035 ratio
Interval -3.778 to 3.849
|
|
Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance
DAY 3, 50h (n=22, 24)
|
-0.764 ratio
Interval -5.208 to 3.68
|
-4.015 ratio
Interval -8.273 to 0.243
|
|
Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance
DAY 3, 54h (n=22,25)
|
-1.737 ratio
Interval -5.915 to 2.44
|
-0.753 ratio
Interval -4.689 to 3.182
|
|
Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance
DAY 180 (n=24,25) end of study
|
0.234 ratio
Interval -3.066 to 3.535
|
0.284 ratio
Interval -2.95 to 3.518
|
SECONDARY outcome
Timeframe: Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusionPopulation: The Pharmacodynamic (PD) analysis set included all patients with available PD data who received any study drug and experienced no protocol deviations with relevant impact on PD data. Any patients who had a reduced flow rate of infusion were excluded from this analysis
Pulse wave velocity was assessed by the SphygmoCor device
Outcome measures
| Measure |
Serelaxin
n=25 Participants
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
n=26 Participants
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis
DAY 1, 0hrs (n=25,26)
|
7.453 meters/second
Standard Deviation 2.0541
|
8.166 meters/second
Standard Deviation 1.9515
|
|
Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis
DAY 2, 24hrs (n=19,24)
|
7.051 meters/second
Standard Deviation 1.8790
|
7.677 meters/second
Standard Deviation 2.1361
|
|
Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis
DAY 3, 47hrs (n=22,23)
|
7.195 meters/second
Standard Deviation 1.9164
|
8.264 meters/second
Standard Deviation 2.4964
|
|
Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis
DAY 30, 0hrs (n=23, 24)
|
7.989 meters/second
Standard Deviation 1.8151
|
8.463 meters/second
Standard Deviation 2.4437
|
|
Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis
DAY 3, 47hrs (n=23,25)
|
29.57 meters/second
Standard Deviation 9.751
|
26.04 meters/second
Standard Deviation 10.039
|
|
Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis
DAY 180 EOS (n=23,24)
|
8.335 meters/second
Standard Deviation 2.1087
|
8.844 meters/second
Standard Deviation 2.1739
|
SECONDARY outcome
Timeframe: Day1, Day 2, Day 3 and Day 30 after the start of infusionPopulation: Pharmacokinetic Analysis Set The PK analysis set includes all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data
Summary statistics of serelaxin serum PK concentrations Blood samples were taken to measure serelaxin concentration
Outcome measures
| Measure |
Serelaxin
n=30 Participants
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Serum Concentration of Serelaxin
DAY 1, 0hrs (n=30)
|
0.637 pg/mL
Standard Deviation 3.49
|
—
|
|
Serum Concentration of Serelaxin
DAY 2, 24hrs, (n=26)
|
27600 pg/mL
Standard Deviation 79000
|
—
|
|
Serum Concentration of Serelaxin
DAY 3, 48hrs (n=22)
|
26300 pg/mL
Standard Deviation 48000
|
—
|
|
Serum Concentration of Serelaxin
DAY 3, 50 hrs (n=21)
|
7940 pg/mL
Standard Deviation 8450
|
—
|
|
Serum Concentration of Serelaxin
DAY 3, 54hrs, (n=22)
|
3960 pg/mL
Standard Deviation 3140
|
—
|
|
Serum Concentration of Serelaxin
DAY 30 (n=30)
|
0.00 pg/mL
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: From pre-dose on Day 1 until Day 30 after the start of drug infusionPopulation: Safety Analysis Set
Frequency and percentage of anti-Serelaxin antibodies Blood samples were taken to measure antibodies to serelaxin concentration at Pre-dose on Day 1, and at Day 30 after the start of the 48h drug infusion
Outcome measures
| Measure |
Serelaxin
n=30 Participants
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
n=28 Participants
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Serum Concentration of Antibodies to Serelaxin
DAY 1 NEGATIVE
|
100 percentage of participants
|
100 percentage of participants
|
|
Serum Concentration of Antibodies to Serelaxin
DAY 1 POSITIVE
|
0 percentage of participants
|
0 percentage of participants
|
|
Serum Concentration of Antibodies to Serelaxin
DAY 30 NEGATIVE
|
100 percentage of participants
|
100 percentage of participants
|
|
Serum Concentration of Antibodies to Serelaxin
DAY 30 POSITIVE
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From pre-dose on Day 1 until 48h after the start of drug infusionPopulation: Pharmacokinetic Analysis Set The PK analysis set includes all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data
Systemic clearance was estimated using the rate of serelaxin infusion and the steady state concentration
Outcome measures
| Measure |
Serelaxin
n=22 Participants
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
|
Placebo
Placebo was administered by intravenous infusion for 48 hours
|
|---|---|---|
|
Systemic Clearance of Serelaxin
|
107 mL/hr/kg
Standard Deviation 80.6
|
—
|
Adverse Events
Serelaxin
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Serelaxin
n=30 participants at risk
Serelaxin
|
Placebo
n=28 participants at risk
Placebo
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
6.7%
2/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Cardiac disorders
Angina pectoris
|
3.3%
1/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Cardiac disorders
Angina unstable
|
3.3%
1/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Immune system disorders
Type IV hypersensitivity reaction
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Nervous system disorders
Presyncope
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
Other adverse events
| Measure |
Serelaxin
n=30 participants at risk
Serelaxin
|
Placebo
n=28 participants at risk
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/30 • Day 180
|
7.1%
2/28 • Day 180
|
|
Cardiac disorders
Extrasystoles
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
General disorders
Chest pain
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
General disorders
Fatigue
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
General disorders
Feeling cold
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
General disorders
Influenza like illness
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
General disorders
Pyrexia
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Infections and infestations
Wound infection
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Investigations
Amylase increased
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Investigations
Blood cholesterol increased
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Investigations
Blood creatine phosphokinase increased
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Investigations
Blood creatinine increased
|
3.3%
1/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Investigations
Blood sodium decreased
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Investigations
Electrocardiogram Q wave abnormal
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Investigations
Glomerular filtration rate decreased
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Investigations
Haematocrit decreased
|
3.3%
1/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Investigations
Haemoglobin decreased
|
6.7%
2/30 • Day 180
|
7.1%
2/28 • Day 180
|
|
Investigations
Lipase increased
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Investigations
Platelet count increased
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Investigations
QRS axis abnormal
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Investigations
Red blood cell count decreased
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30 • Day 180
|
7.1%
2/28 • Day 180
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Day 180
|
14.3%
4/28 • Day 180
|
|
Nervous system disorders
Presyncope
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Nervous system disorders
Sciatica
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Psychiatric disorders
Agitation
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Day 180
|
0.00%
0/28 • Day 180
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/30 • Day 180
|
3.6%
1/28 • Day 180
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER