Trial Outcomes & Findings for Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients (NCT NCT02002702)
NCT ID: NCT02002702
Last Updated: 2015-10-12
Results Overview
AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. AEs leading to discontinuations, or requiring dose adjustment or interruptions and additional therapy were assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
From start of study treatment up to Day 5 (for AEs); From start of study treatment up to Day 14 (for SAEs)
Results posted on
2015-10-12
Participant Flow
The study was conducted at 15 centers in Japan.
Participant milestones
| Measure |
Serelaxin 10 mcg/kg/Day
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
15
|
|
Overall Study
COMPLETED
|
16
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
Baseline characteristics by cohort
| Measure |
Serelaxin 10 mcg/kg/Day
n=16 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=15 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
n=15 Participants
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 11.77 • n=93 Participants
|
79.7 years
STANDARD_DEVIATION 9.01 • n=4 Participants
|
76.4 years
STANDARD_DEVIATION 12.08 • n=27 Participants
|
75.3 years
STANDARD_DEVIATION 11.54 • n=483 Participants
|
|
Age, Customized
< 65 years
|
6 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
10 participants
n=483 Participants
|
|
Age, Customized
≥ 65 years
|
10 participants
n=93 Participants
|
14 participants
n=4 Participants
|
12 participants
n=27 Participants
|
36 participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
34 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment up to Day 5 (for AEs); From start of study treatment up to Day 14 (for SAEs)Population: The analysis was performed on the safety population, defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment.
AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. AEs leading to discontinuations, or requiring dose adjustment or interruptions and additional therapy were assessed.
Outcome measures
| Measure |
Serelaxin 10 mcg/kg/Day
n=16 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=15 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
n=15 Participants
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy
Discontinuation due to SAE(s)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy
AEs
|
10 participants
|
11 participants
|
9 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy
SAEs
|
1 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy
Death
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy
Discontinuation due to AE(s)
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy
AEs requiring dose adjustment or interruption
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy
AEs requiring additional therapy
|
8 participants
|
10 participants
|
9 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy
AEs related to study drug
|
2 participants
|
2 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)Population: The analysis was performed in the pharmacokinetic (PK) set, defined as all participants who received study treatment and had at least one evaluable PK parameter data. Here, "Number of participants analyzed" signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively.
Maximum plasma concentration (Cmax) was defined as the peak level of serelaxin, derived from plasma concentration-time data, using a non-compartmental model approach.
Outcome measures
| Measure |
Serelaxin 10 mcg/kg/Day
n=12 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=8 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Serelaxin
|
8.01 nanogram(s)/milliliter (ng/mL)
Standard Deviation 2.07
|
19.2 nanogram(s)/milliliter (ng/mL)
Standard Deviation 4.69
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)Population: The analysis was performed in the PK population. Here, "Number of participants analyzed" signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively.
Weight adjusted clearance (CL) was defined as the total body clearance of serelaxin after drug administration. CL was calculated as nominal infusion rate divided by Css, using a non-compartmental model approach.
Outcome measures
| Measure |
Serelaxin 10 mcg/kg/Day
n=12 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=8 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Weight Adjusted Clearance (CL) of Serelaxin
|
56.8 mL/hr/kg
Standard Deviation 15.4
|
70.2 mL/hr/kg
Standard Deviation 23.2
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)Population: The analysis was performed in the PK population. Here, "Number of participants analyzed" signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively.
Concentration at steady-state (Css) was defined as concentration at the state of equilibrium obtained at the end of a certain number of administrations. Css of serelaxin in plasma was calculated by using a non-compartmental model approach.
Outcome measures
| Measure |
Serelaxin 10 mcg/kg/Day
n=12 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=8 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Concentration at Steady-state (Css) of Serelaxin
|
7.81 ng/mL
Standard Deviation 1.96
|
19.1 ng/mL
Standard Deviation 4.61
|
—
|
SECONDARY outcome
Timeframe: Baseline, 48 hours, Day 5Population: The analysis was performed in the full analysis set (FAS) population, defined as all participants who were randomized in the study.
The area under the curve (AUC) was defined as area under the plasma concentration-time curve from time zero to time of the last time point with measurable concentration, calculated by a trapezoidal method. Systolic blood pressure was measured using a calibrated standard sphygmomanometer after the subject remained in sitting position for 3 minutes at clinic during the visit. Sample collected at: Baseline; 30 \& 60 minutes and then every hour for the first 6 hours of study drug infusion, and then every 3 hours during 48 hours of study drug infusion; every 3 hours until 12 hours following end of infusion, then every 6 hours for 48 hours and then every 24 hours until the earlier of Day 5 or discharge. AUC for SBP is standardized by dividing by the length of respective time ranges.
Outcome measures
| Measure |
Serelaxin 10 mcg/kg/Day
n=16 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=15 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
n=15 Participants
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5
48 hours
|
-8.21 mmHg
Standard Error 2.903
|
-18.6 mmHg
Standard Error 3.018
|
-10.88 mmHg
Standard Error 3.018
|
|
Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5
Day 5
|
-8.79 mmHg
Standard Error 2.761
|
-22.14 mmHg
Standard Error 2.871
|
-14.77 mmHg
Standard Error 2.871
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 5, Day 14Population: The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.
Aldosterone biomarker was used to assess the effect of serelaxinin on fluid retention. Geometric means of the ratio of post-Baseline values to baseline values of aldosterone was calculated by treatment for the full analysis set.
Outcome measures
| Measure |
Serelaxin 10 mcg/kg/Day
n=16 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=15 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
n=15 Participants
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Change From Baseline in Aldosterone Levels Through Day 14
Day 1
|
0.985 Ratio
Interval 0.7636 to 1.2717
|
0.816 Ratio
Interval 0.6118 to 1.0897
|
0.791 Ratio
Interval 0.6374 to 0.9825
|
|
Change From Baseline in Aldosterone Levels Through Day 14
Day 2
|
0.975 Ratio
Interval 0.7492 to 1.2685
|
0.721 Ratio
Interval 0.5195 to 0.9999
|
0.911 Ratio
Interval 0.7141 to 1.162
|
|
Change From Baseline in Aldosterone Levels Through Day 14
Day 5
|
0.895 Ratio
Interval 0.6327 to 1.2656
|
0.825 Ratio
Interval 0.6468 to 1.0531
|
0.816 Ratio
Interval 0.5352 to 1.2452
|
|
Change From Baseline in Aldosterone Levels Through Day 14
Day 14
|
1.510 Ratio
Interval 0.9934 to 2.2962
|
1.114 Ratio
Interval 0.7983 to 1.5555
|
1.179 Ratio
Interval 0.8337 to 1.6661
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 5, Day 14Population: The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.
Cystatin-C biomarker was used to assess the effect of serelaxinin on worsening of renal function. Geometric means of the ratio of post-Baseline values to baseline values of Cystatin-C was calculated by treatment for the full analysis set.
Outcome measures
| Measure |
Serelaxin 10 mcg/kg/Day
n=16 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=15 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
n=15 Participants
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Change From Baseline in Cystatin-C Levels Through Day 14
Day 1
|
0.921 Ratio
Interval 0.8863 to 0.9565
|
0.988 Ratio
Interval 0.9213 to 1.0598
|
0.985 Ratio
Interval 0.9291 to 1.045
|
|
Change From Baseline in Cystatin-C Levels Through Day 14
Day 2
|
0.930 Ratio
Interval 0.8736 to 0.99
|
0.852 Ratio
Interval 0.6465 to 1.1236
|
0.965 Ratio
Interval 0.9002 to 1.0346
|
|
Change From Baseline in Cystatin-C Levels Through Day 14
Day 5
|
1.062 Ratio
Interval 0.9898 to 1.1384
|
1.115 Ratio
Interval 1.0207 to 1.2178
|
1.038 Ratio
Interval 0.9627 to 1.1194
|
|
Change From Baseline in Cystatin-C Levels Through Day 14
Day 14
|
1.195 Ratio
Interval 1.0154 to 1.4057
|
1.136 Ratio
Interval 1.0348 to 1.2472
|
1.125 Ratio
Interval 1.0313 to 1.2271
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 5, Day 14Population: The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.
High sensitivity Troponin-T biomarker was used to assess the effect of serelaxin on myocardial damage. Geometric means of the ratio of post-Baseline values to baseline values of high sensitivity troponin-t was calculated by treatment for the full analysis set.
Outcome measures
| Measure |
Serelaxin 10 mcg/kg/Day
n=16 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=15 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
n=15 Participants
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14
Day 1
|
0.899 Ratio
Interval 0.7598 to 1.0643
|
1.060 Ratio
Interval 0.8932 to 1.2572
|
0.956 Ratio
Interval 0.8652 to 1.0559
|
|
Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14
Day 2
|
0.856 Ratio
Interval 0.6935 to 1.0553
|
1.040 Ratio
Interval 0.8514 to 1.2714
|
0.894 Ratio
Interval 0.765 to 1.0442
|
|
Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14
Day 5
|
0.849 Ratio
Interval 0.5984 to 1.2044
|
0.972 Ratio
Interval 0.7779 to 1.2151
|
0.779 Ratio
Interval 0.525 to 1.1572
|
|
Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14
Day 14
|
0.820 Ratio
Interval 0.5729 to 1.173
|
0.813 Ratio
Interval 0.448 to 1.4748
|
0.685 Ratio
Interval 0.4652 to 1.0093
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 5, Day 14Population: The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.
NT-proBNP biomarker was used to assess the effect of serelaxinin on degree of cardiac wall stress and congestion. Geometric means of the ratio of post-Baseline values to baseline values of NT-proBNP was calculated by treatment for the full analysis set.
Outcome measures
| Measure |
Serelaxin 10 mcg/kg/Day
n=16 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=15 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
n=15 Participants
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Change From Baseline in NT-proBNP Levels Through Day 14
Day 1
|
0.585 Ratio
Interval 0.4356 to 0.7865
|
0.646 Ratio
Interval 0.5146 to 0.8115
|
0.673 Ratio
Interval 0.5416 to 0.8363
|
|
Change From Baseline in NT-proBNP Levels Through Day 14
Day 2
|
0.492 Ratio
Interval 0.3421 to 0.7076
|
0.451 Ratio
Interval 0.3271 to 0.621
|
0.581 Ratio
Interval 0.441 to 0.7656
|
|
Change From Baseline in NT-proBNP Levels Through Day 14
Day 5
|
0.388 Ratio
Interval 0.2502 to 0.6028
|
0.386 Ratio
Interval 0.2575 to 0.5796
|
0.526 Ratio
Interval 0.3685 to 0.7503
|
|
Change From Baseline in NT-proBNP Levels Through Day 14
Day 14
|
0.295 Ratio
Interval 0.1649 to 0.5293
|
0.419 Ratio
Interval 0.2621 to 0.6691
|
0.277 Ratio
Interval 0.1875 to 0.4079
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 5, Day 14Population: The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.
Neutrophil gelatinase-asc lipocalin (NGAL) biomarker was used to assess the effect of serelaxin on kidney function. Geometric means of the ratio of post-Baseline values to baseline values of NGAL was calculated by treatment for the full analysis set.
Outcome measures
| Measure |
Serelaxin 10 mcg/kg/Day
n=16 Participants
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=15 Participants
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
n=15 Participants
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14
Day 1
|
1.011 Ratio
Interval 0.8911 to 1.1478
|
1.083 Ratio
Interval 0.9025 to 1.2996
|
1.054 Ratio
Interval 0.9574 to 1.1613
|
|
Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14
Day 2
|
0.929 Ratio
Interval 0.8443 to 1.0229
|
1.172 Ratio
Interval 0.9994 to 1.3736
|
1.099 Ratio
Interval 0.9866 to 1.2236
|
|
Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14
Day 5
|
1.129 Ratio
Interval 1.0145 to 1.256
|
1.238 Ratio
Interval 1.0139 to 1.5114
|
1.135 Ratio
Interval 1.0141 to 1.2698
|
|
Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14
Day 14
|
1.434 Ratio
Interval 1.176 to 1.7489
|
1.520 Ratio
Interval 1.3214 to 1.7485
|
1.433 Ratio
Interval 1.1793 to 1.7401
|
Adverse Events
Serelaxin 10 mcg/kg/Day
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serelaxin 30 mcg/kg/Day
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Serelaxin 10 mcg/kg/Day
n=16 participants at risk
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=15 participants at risk
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
n=15 participants at risk
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
MULTI-ORGAN FAILURE
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LYMPH NODES
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO PERITONEUM
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CARCINOMA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
Other adverse events
| Measure |
Serelaxin 10 mcg/kg/Day
n=16 participants at risk
Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
|
Serelaxin 30 mcg/kg/Day
n=15 participants at risk
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
|
Placebo
n=15 participants at risk
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
20.0%
3/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
26.7%
4/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
INFUSION SITE PAIN
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
INFECTION
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
BLOOD PRESSURE DECREASED
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
BLOOD PRESSURE SYSTOLIC DECREASED
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
PLATELET COUNT DECREASED
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
13.3%
2/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
13.3%
2/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Nervous system disorders
HEADACHE
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Psychiatric disorders
DELIRIUM
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Psychiatric disorders
RESTLESSNESS
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Renal and urinary disorders
HAEMATURIA
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Reproductive system and breast disorders
GENITAL PAIN
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
6.7%
1/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Vascular disorders
VASCULITIS
|
6.2%
1/16 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/15 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 -778 -8300
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