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Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF (RELAX-AHF-2)

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ClinicalTrials.gov Identifier: NCT01870778
Recruitment Status : Completed
First Posted : June 6, 2013
Results First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Heart Failure
Interventions Drug: RLX030
Drug: Placebo
Enrollment 6600
Recruitment Details  
Pre-assignment Details 6600 participants were randomized into the trial. Only 6545 participants were eligible for analysis. Therefore, the participants flow and baseline characteristics are based on 6545 participants.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours. Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Period Title: Overall Study
Started 3274 3271
Safety Set 3257 3248
Full Analysis Set 3274 3271
Biomarker Analysis Set 521 510
Completed 3266 3262
Not Completed 8 9
Reason Not Completed
Withdrawal by Subject             8             7
Lost to Follow-up             0             2
Arm/Group Title Serelaxin (RLX030) Placebo Total
Hide Arm/Group Description Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours. Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours. Total of all reporting groups
Overall Number of Baseline Participants 3274 3271 6545
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3274 participants 3271 participants 6545 participants
73.1  (11.24) 72.8  (11.17) 73.0  (11.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3274 participants 3271 participants 6545 participants
Female
1296
  39.6%
1341
  41.0%
2637
  40.3%
Male
1978
  60.4%
1930
  59.0%
3908
  59.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3274 participants 3271 participants 6545 participants
American Indian or Alaska Native
13
   0.4%
18
   0.6%
31
   0.5%
Asian
14
   0.4%
16
   0.5%
30
   0.5%
Native Hawaiian or Other Pacific Islander
4
   0.1%
4
   0.1%
8
   0.1%
Black or African American
163
   5.0%
171
   5.2%
334
   5.1%
White
3017
  92.2%
2999
  91.7%
6016
  91.9%
More than one race
46
   1.4%
46
   1.4%
92
   1.4%
Unknown or Not Reported
17
   0.5%
17
   0.5%
34
   0.5%
1.Primary Outcome
Title Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180
Hide Description The percentage of participants with an adjudicated CV death through day 180 was assessed.
Time Frame 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description:
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Overall Number of Participants Analyzed 3274 3271
Measure Type: Number
Unit of Measure: Percentage of participants
8.7 8.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3857
Comments Adjusted alpha p-value based on multiple testing procedure.
Method Log Rank
Comments One-sided p-value
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.83 to 1.15
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5
Hide Description The percentage of participants with WHF through day 5 was assessed.
Time Frame Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description:
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Overall Number of Participants Analyzed 3274 3271
Measure Type: Number
Unit of Measure: Percentage of participants
6.9 7.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0968
Comments Adjusted p-value based on multiple testing procedure
Method Gehan's generalized Wilcoxon test
Comments One-sided p-value
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.75 to 1.07
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With All-cause Death Through Day 180
Hide Description The percentage of participants with all-cause death through day 180 was assessed.
Time Frame 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description:
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Overall Number of Participants Analyzed 3274 3271
Measure Type: Number
Unit of Measure: Percentage of participants
11.2 11.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3890
Comments [Not Specified]
Method Log Rank
Comments 2-sided p-value
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.81 to 1.08
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization
Hide Description Length of stay was defined as the index hospitalization discharge date and time minus the baseline date and time plus 1 day.
Time Frame 180 days (Participants still in the hospital at Day 60 were censored at Day 60)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description:
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Overall Number of Participants Analyzed 3274 3271
Mean (Standard Deviation)
Unit of Measure: days
9.362  (9.3581) 9.545  (9.6739)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2204
Comments Based on multiple testing procedure
Method Wilcoxon rank sum test
Comments One-sided p-value
5.Secondary Outcome
Title Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization
Hide Description The percentage of participants with adjudicated CV death or adjudicated re-hospitalization through day 180 was assessed.
Time Frame 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description:
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Overall Number of Participants Analyzed 3274 3271
Measure Type: Number
Unit of Measure: Percentage of participants
24.3 24.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2744
Comments Adjusted p-value based on multiple testing procedure
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.88 to 1.07
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
Hide Description Length of stay was defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day.
Time Frame 180 days (Patients still in the hospital at Day 60 were censored at Day 60)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description:
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Overall Number of Participants Analyzed 3274 3271
Mean (Standard Deviation)
Unit of Measure: days
3.8  (8.29) 4.1  (8.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2103
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments 2-sided p-value
7.Secondary Outcome
Title Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure
Hide Description The percentage of participants with first improvement since baseline in congestive signs and symptoms was assessed. The signs and symptoms included exertional dyspnea, orthopnea, rales, jugular venous pressure and peripheral edema/pre-sacral edema.
Time Frame From baseline to Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was considered for the analysis. For each symptom, only participants with observed baseline signs and symptoms and non-missing baseline and post baseline signs and symptoms were analyzed.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description:
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Overall Number of Participants Analyzed 3044 3039
Measure Type: Number
Unit of Measure: Percentage of participants
Exertional dyspnea Number Analyzed 3044 participants 3039 participants
94.1 92.6
Orthopnea Number Analyzed 2937 participants 2967 participants
92.9 91.2
Rales Number Analyzed 2888 participants 2877 participants
94.1 93.7
Jugular venous pressure Number Analyzed 2054 participants 2034 participants
90.4 88.0
Peripheral edema, pre-sacral edema Number Analyzed 2597 participants 2622 participants
91.6 90.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Exertional dyspnea
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0050
Comments [Not Specified]
Method Log Rank
Comments 2-sided p-value
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
1.02 to 1.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Orthopnea
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0051
Comments [Not Specified]
Method Log Rank
Comments 2-sided p-value
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
1.02 to 1.14
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Rales
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9962
Comments [Not Specified]
Method Log Rank
Comments 2-sided p-value
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.95 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Jugular venous pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0196
Comments [Not Specified]
Method Log Rank
Comments 2-sided p-value
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
1.01 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Peripheral edema, pre-sacral edema
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2158
Comments [Not Specified]
Method Log Rank
Comments 2-sided p-value
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.98 to 1.10
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in hsTroponin T Biomarker
Hide Description Blood samples were collected to assess the change from baseline in hsTroponin T. The geometric least square mean (LSM) of the ratio of the post-baseline value to the baseline value is presented.
Time Frame Baseline, Day 2, Day 5 and Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description:
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Overall Number of Participants Analyzed 521 510
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: ug/L
Day 2 Number Analyzed 464 participants 459 participants
0.9808
(0.9452 to 1.0177)
1.0432
(1.0052 to 1.0827)
Day 5 Number Analyzed 458 participants 449 participants
0.9589
(0.9116 to 1.0087)
1.0678
(1.0148 to 1.1237)
Day 14 Number Analyzed 436 participants 418 participants
0.7813
(0.7374 to 0.8278)
0.8611
(0.8119 to 0.9132)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0209
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of RLX030 to placebo
Estimated Value 0.9401
Confidence Interval (2-Sided) 95%
0.8921 to 0.9907
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Day 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of RLX030 to placebo
Estimated Value 0.8980
Confidence Interval (2-Sided) 95%
0.8358 to 0.9649
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Day 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0209
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of RLX030 to placebo
Estimated Value 0.9074
Confidence Interval (2-Sided) 95%
0.8355 to 0.9854
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in NT-proBNP Biomarker
Hide Description Blood samples were collected to assess the change from baseline in NT-proBNP. The ratio of the post-baseline value to the baseline value is presented.
Time Frame Baseline, Day 2, Day 5 and Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description:
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Overall Number of Participants Analyzed 521 510
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: pg/mL
Day 2 Number Analyzed 472 participants 465 participants
0.4902
(0.4609 to 0.5214)
0.5702
(0.5358 to 0.6068)
Day 5 Number Analyzed 465 participants 455 participants
0.4249
(0.3950 to 0.4570)
0.4454
(0.4138 to 0.4794)
Day 14 Number Analyzed 446 participants 429 participants
0.4265
(0.3957 to 0.4596)
0.4469
(0.4143 to 0.4822)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of RLX030 to placebo
Estimated Value 0.8597
Confidence Interval (2-Sided) 95%
0.7876 to 0.9385
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Day 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3709
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of RLX030 to placebo
Estimated Value 0.9539
Confidence Interval (2-Sided) 95%
0.8600 to 1.0579
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Day 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3893
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of RLX030 to placebo
Estimated Value 0.9543
Confidence Interval (2-Sided) 95%
0.8578 to 1.0617
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Cystatin C Biomarker
Hide Description Blood samples were collected to assess the change from baseline in Cystatin C. The ratio of the post-baseline value to the baseline value is presented.
Time Frame Baseline, Day 2, Day 5 and Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description:
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Overall Number of Participants Analyzed 521 510
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/L
Day 2 Number Analyzed 474 participants 465 participants
1.0261
(1.0119 to 1.0406)
1.0648
(1.0499 to 1.0799)
Day 5 Number Analyzed 467 participants 456 participants
1.1171
(1.0976 to 1.1369)
1.1259
(1.1061 to 1.1461)
Day 14 Number Analyzed 445 participants 432 participants
1.1186
(1.0949 to 1.1429)
1.1342
(1.1098 to 1.1591)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of RLX030 to placebo
Estimated Value 0.9637
Confidence Interval (2-Sided) 95%
0.9447 to 0.9830
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Day 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5361
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of RLX030 to placebo
Estimated Value 0.9922
Confidence Interval (2-Sided) 95%
0.9677 to 1.0172
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Serelaxin (RLX030), Placebo
Comments Day 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3750
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of RLX030 to placebo
Estimated Value 0.9863
Confidence Interval (2-Sided) 95%
0.9567 to 1.0169
Estimation Comments [Not Specified]
Time Frame up to 180 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Serelaxin (RLX030) Placebo
Hide Arm/Group Description Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours. Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
All-Cause Mortality
Serelaxin (RLX030) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   363/3257 (11.15%)   386/3248 (11.88%) 
Show Serious Adverse Events Hide Serious Adverse Events
Serelaxin (RLX030) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   412/3257 (12.65%)   424/3248 (13.05%) 
Blood and lymphatic system disorders     
Anaemia  1  7/3257 (0.21%)  7/3248 (0.22%) 
Anaemia macrocytic  1  1/3257 (0.03%)  0/3248 (0.00%) 
Haemorrhagic anaemia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Heparin-induced thrombocytopenia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Leukocytosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Leukopenia  1  1/3257 (0.03%)  0/3248 (0.00%) 
Lymphadenopathy  1  0/3257 (0.00%)  1/3248 (0.03%) 
Cardiac disorders     
Acute coronary syndrome  1  1/3257 (0.03%)  3/3248 (0.09%) 
Acute left ventricular failure  1  1/3257 (0.03%)  0/3248 (0.00%) 
Acute myocardial infarction  1  14/3257 (0.43%)  12/3248 (0.37%) 
Angina pectoris  1  1/3257 (0.03%)  7/3248 (0.22%) 
Angina unstable  1  2/3257 (0.06%)  2/3248 (0.06%) 
Aortic valve incompetence  1  1/3257 (0.03%)  2/3248 (0.06%) 
Aortic valve stenosis  1  4/3257 (0.12%)  9/3248 (0.28%) 
Arrhythmia  1  0/3257 (0.00%)  2/3248 (0.06%) 
Arteriosclerosis coronary artery  1  2/3257 (0.06%)  0/3248 (0.00%) 
Atrial fibrillation  1  10/3257 (0.31%)  13/3248 (0.40%) 
Atrial flutter  1  2/3257 (0.06%)  2/3248 (0.06%) 
Atrial thrombosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Atrioventricular block  1  1/3257 (0.03%)  0/3248 (0.00%) 
Atrioventricular block complete  1  5/3257 (0.15%)  2/3248 (0.06%) 
Atrioventricular block second degree  1  0/3257 (0.00%)  1/3248 (0.03%) 
Atrioventricular dissociation  1  1/3257 (0.03%)  0/3248 (0.00%) 
Bradyarrhythmia  1  1/3257 (0.03%)  1/3248 (0.03%) 
Bradycardia  1  4/3257 (0.12%)  4/3248 (0.12%) 
Cardiac arrest  1  4/3257 (0.12%)  9/3248 (0.28%) 
Cardiac failure  1  62/3257 (1.90%)  68/3248 (2.09%) 
Cardiac failure acute  1  14/3257 (0.43%)  8/3248 (0.25%) 
Cardiac failure chronic  1  2/3257 (0.06%)  3/3248 (0.09%) 
Cardiac failure congestive  1  12/3257 (0.37%)  9/3248 (0.28%) 
Cardio-respiratory arrest  1  2/3257 (0.06%)  2/3248 (0.06%) 
Cardiogenic shock  1  5/3257 (0.15%)  6/3248 (0.18%) 
Cardiopulmonary failure  1  1/3257 (0.03%)  0/3248 (0.00%) 
Cardiorenal syndrome  1  1/3257 (0.03%)  2/3248 (0.06%) 
Chordae tendinae rupture  1  2/3257 (0.06%)  1/3248 (0.03%) 
Congestive cardiomyopathy  1  0/3257 (0.00%)  2/3248 (0.06%) 
Coronary artery disease  1  17/3257 (0.52%)  12/3248 (0.37%) 
Coronary artery occlusion  1  1/3257 (0.03%)  1/3248 (0.03%) 
Coronary artery perforation  1  1/3257 (0.03%)  0/3248 (0.00%) 
Coronary artery stenosis  1  5/3257 (0.15%)  2/3248 (0.06%) 
Defect conduction intraventricular  1  0/3257 (0.00%)  1/3248 (0.03%) 
Ischaemic cardiomyopathy  1  1/3257 (0.03%)  0/3248 (0.00%) 
Left ventricular dysfunction  1  2/3257 (0.06%)  0/3248 (0.00%) 
Mitral valve incompetence  1  5/3257 (0.15%)  5/3248 (0.15%) 
Mitral valve stenosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Myocardial infarction  1  3/3257 (0.09%)  4/3248 (0.12%) 
Myocardial ischaemia  1  2/3257 (0.06%)  3/3248 (0.09%) 
Pericarditis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Sinus bradycardia  1  1/3257 (0.03%)  2/3248 (0.06%) 
Sinus node dysfunction  1  1/3257 (0.03%)  2/3248 (0.06%) 
Supraventricular tachycardia  1  1/3257 (0.03%)  2/3248 (0.06%) 
Tachyarrhythmia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Tachycardia  1  1/3257 (0.03%)  0/3248 (0.00%) 
Torsade de pointes  1  1/3257 (0.03%)  0/3248 (0.00%) 
Ventricular arrhythmia  1  1/3257 (0.03%)  1/3248 (0.03%) 
Ventricular fibrillation  1  4/3257 (0.12%)  6/3248 (0.18%) 
Ventricular tachycardia  1  14/3257 (0.43%)  11/3248 (0.34%) 
Endocrine disorders     
Hyperthyroidism  1  0/3257 (0.00%)  1/3248 (0.03%) 
Gastrointestinal disorders     
Abdominal pain  1  2/3257 (0.06%)  0/3248 (0.00%) 
Ascites  1  1/3257 (0.03%)  0/3248 (0.00%) 
Colitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Diarrhoea  1  1/3257 (0.03%)  0/3248 (0.00%) 
Duodenal ulcer haemorrhage  1  1/3257 (0.03%)  1/3248 (0.03%) 
Dyspepsia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Enterocolitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Gastritis  1  1/3257 (0.03%)  0/3248 (0.00%) 
Gastritis erosive  1  1/3257 (0.03%)  0/3248 (0.00%) 
Gastroduodenal ulcer  1  1/3257 (0.03%)  0/3248 (0.00%) 
Gastrointestinal haemorrhage  1  2/3257 (0.06%)  2/3248 (0.06%) 
Haematochezia  1  1/3257 (0.03%)  0/3248 (0.00%) 
Ileus  1  2/3257 (0.06%)  0/3248 (0.00%) 
Ileus paralytic  1  0/3257 (0.00%)  1/3248 (0.03%) 
Inguinal hernia  1  1/3257 (0.03%)  1/3248 (0.03%) 
Intestinal stenosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Large intestinal haemorrhage  1  0/3257 (0.00%)  1/3248 (0.03%) 
Large intestine polyp  1  1/3257 (0.03%)  0/3248 (0.00%) 
Melaena  1  1/3257 (0.03%)  0/3248 (0.00%) 
Pancreatitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Peritoneal haemorrhage  1  0/3257 (0.00%)  1/3248 (0.03%) 
Rectal haemorrhage  1  1/3257 (0.03%)  1/3248 (0.03%) 
Retroperitoneal haemorrhage  1  1/3257 (0.03%)  0/3248 (0.00%) 
Small intestinal obstruction  1  0/3257 (0.00%)  1/3248 (0.03%) 
Subileus  1  0/3257 (0.00%)  1/3248 (0.03%) 
Vomiting  1  1/3257 (0.03%)  0/3248 (0.00%) 
General disorders     
Asthenia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Cardiac death  1  0/3257 (0.00%)  2/3248 (0.06%) 
Drug effect increased  1  1/3257 (0.03%)  0/3248 (0.00%) 
Extravasation  1  0/3257 (0.00%)  1/3248 (0.03%) 
Fatigue  1  0/3257 (0.00%)  1/3248 (0.03%) 
General physical health deterioration  1  1/3257 (0.03%)  0/3248 (0.00%) 
Inflammation  1  1/3257 (0.03%)  0/3248 (0.00%) 
Infusion site phlebitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Multiple organ dysfunction syndrome  1  4/3257 (0.12%)  1/3248 (0.03%) 
Non-cardiac chest pain  1  2/3257 (0.06%)  0/3248 (0.00%) 
Pyrexia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Sudden cardiac death  1  3/3257 (0.09%)  6/3248 (0.18%) 
Sudden death  1  0/3257 (0.00%)  1/3248 (0.03%) 
Vascular stent occlusion  1  0/3257 (0.00%)  1/3248 (0.03%) 
Hepatobiliary disorders     
Alcoholic liver disease  1  0/3257 (0.00%)  1/3248 (0.03%) 
Drug-induced liver injury  1  0/3257 (0.00%)  1/3248 (0.03%) 
Hepatic congestion  1  1/3257 (0.03%)  0/3248 (0.00%) 
Hepatic failure  1  2/3257 (0.06%)  3/3248 (0.09%) 
Hepatic function abnormal  1  1/3257 (0.03%)  0/3248 (0.00%) 
Hepatocellular injury  1  2/3257 (0.06%)  1/3248 (0.03%) 
Hyperbilirubinaemia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Jaundice  1  1/3257 (0.03%)  0/3248 (0.00%) 
Liver injury  1  1/3257 (0.03%)  1/3248 (0.03%) 
Immune system disorders     
Hypersensitivity  1  1/3257 (0.03%)  0/3248 (0.00%) 
Infections and infestations     
Abdominal abscess  1  1/3257 (0.03%)  0/3248 (0.00%) 
Appendicitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Arthritis bacterial  1  1/3257 (0.03%)  0/3248 (0.00%) 
Aspergilloma  1  0/3257 (0.00%)  1/3248 (0.03%) 
Bacteraemia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Bronchitis  1  9/3257 (0.28%)  4/3248 (0.12%) 
Cellulitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Cholecystitis infective  1  1/3257 (0.03%)  0/3248 (0.00%) 
Chronic hepatitis B  1  1/3257 (0.03%)  0/3248 (0.00%) 
Clostridium difficile infection  1  1/3257 (0.03%)  1/3248 (0.03%) 
Cystitis  1  3/3257 (0.09%)  1/3248 (0.03%) 
Cystitis bacterial  1  0/3257 (0.00%)  1/3248 (0.03%) 
Device related infection  1  0/3257 (0.00%)  1/3248 (0.03%) 
Diverticulitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Enterocolitis bacterial  1  0/3257 (0.00%)  1/3248 (0.03%) 
Erysipelas  1  1/3257 (0.03%)  0/3248 (0.00%) 
Gastroenteritis  1  2/3257 (0.06%)  2/3248 (0.06%) 
Gastroenteritis clostridial  1  0/3257 (0.00%)  1/3248 (0.03%) 
Influenza  1  1/3257 (0.03%)  0/3248 (0.00%) 
Intervertebral discitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Lower respiratory tract infection  1  2/3257 (0.06%)  0/3248 (0.00%) 
Nasopharyngitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Nosocomial infection  1  1/3257 (0.03%)  0/3248 (0.00%) 
Orchitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Pharyngitis  1  1/3257 (0.03%)  0/3248 (0.00%) 
Pneumococcal sepsis  1  1/3257 (0.03%)  0/3248 (0.00%) 
Pneumonia  1  34/3257 (1.04%)  32/3248 (0.99%) 
Pneumonia streptococcal  1  1/3257 (0.03%)  0/3248 (0.00%) 
Pulmonary sepsis  1  1/3257 (0.03%)  1/3248 (0.03%) 
Pyelonephritis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Respiratory tract infection  1  0/3257 (0.00%)  1/3248 (0.03%) 
Sepsis  1  6/3257 (0.18%)  8/3248 (0.25%) 
Septic shock  1  4/3257 (0.12%)  2/3248 (0.06%) 
Staphylococcal bacteraemia  1  2/3257 (0.06%)  3/3248 (0.09%) 
Staphylococcal infection  1  0/3257 (0.00%)  1/3248 (0.03%) 
Streptococcal bacteraemia  1  1/3257 (0.03%)  0/3248 (0.00%) 
Streptococcal sepsis  1  1/3257 (0.03%)  0/3248 (0.00%) 
Urinary tract infection  1  13/3257 (0.40%)  5/3248 (0.15%) 
Urinary tract infection pseudomonal  1  0/3257 (0.00%)  1/3248 (0.03%) 
Urosepsis  1  1/3257 (0.03%)  3/3248 (0.09%) 
Injury, poisoning and procedural complications     
Aortic restenosis  1  1/3257 (0.03%)  0/3248 (0.00%) 
Cardiac valve replacement complication  1  0/3257 (0.00%)  1/3248 (0.03%) 
Coronary artery restenosis  1  2/3257 (0.06%)  1/3248 (0.03%) 
Facial bones fracture  1  0/3257 (0.00%)  1/3248 (0.03%) 
Fall  1  1/3257 (0.03%)  0/3248 (0.00%) 
Femoral neck fracture  1  2/3257 (0.06%)  0/3248 (0.00%) 
Lumbar vertebral fracture  1  2/3257 (0.06%)  0/3248 (0.00%) 
Post procedural myocardial infarction  1  1/3257 (0.03%)  0/3248 (0.00%) 
Procedural complication  1  1/3257 (0.03%)  0/3248 (0.00%) 
Procedural hypotension  1  1/3257 (0.03%)  0/3248 (0.00%) 
Procedural pneumothorax  1  0/3257 (0.00%)  1/3248 (0.03%) 
Rib fracture  1  1/3257 (0.03%)  0/3248 (0.00%) 
Subdural haematoma  1  0/3257 (0.00%)  2/3248 (0.06%) 
Toxicity to various agents  1  1/3257 (0.03%)  0/3248 (0.00%) 
Vascular pseudoaneurysm  1  0/3257 (0.00%)  2/3248 (0.06%) 
Investigations     
Aspartate aminotransferase increased  1  1/3257 (0.03%)  0/3248 (0.00%) 
Blood bilirubin increased  1  2/3257 (0.06%)  0/3248 (0.00%) 
Blood creatinine increased  1  1/3257 (0.03%)  2/3248 (0.06%) 
Blood pressure decreased  1  0/3257 (0.00%)  2/3248 (0.06%) 
C-reactive protein increased  1  1/3257 (0.03%)  1/3248 (0.03%) 
Cardiac output decreased  1  1/3257 (0.03%)  0/3248 (0.00%) 
Ejection fraction decreased  1  2/3257 (0.06%)  2/3248 (0.06%) 
Electrocardiogram T wave inversion  1  0/3257 (0.00%)  1/3248 (0.03%) 
Haemoglobin decreased  1  0/3257 (0.00%)  1/3248 (0.03%) 
Hepatic enzyme increased  1  3/3257 (0.09%)  1/3248 (0.03%) 
Liver function test increased  1  0/3257 (0.00%)  1/3248 (0.03%) 
Oxygen saturation decreased  1  1/3257 (0.03%)  0/3248 (0.00%) 
Troponin increased  1  1/3257 (0.03%)  1/3248 (0.03%) 
Vascular resistance pulmonary increased  1  1/3257 (0.03%)  0/3248 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  3/3257 (0.09%)  1/3248 (0.03%) 
Diabetes mellitus  1  0/3257 (0.00%)  1/3248 (0.03%) 
Gout  1  1/3257 (0.03%)  1/3248 (0.03%) 
Hyperkalaemia  1  3/3257 (0.09%)  2/3248 (0.06%) 
Hypoglycaemia  1  1/3257 (0.03%)  2/3248 (0.06%) 
Hypokalaemia  1  1/3257 (0.03%)  1/3248 (0.03%) 
Hyponatraemia  1  1/3257 (0.03%)  0/3248 (0.00%) 
Hypovolaemia  1  1/3257 (0.03%)  0/3248 (0.00%) 
Lactic acidosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Metabolic acidosis  1  1/3257 (0.03%)  0/3248 (0.00%) 
Metabolic alkalosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Type 2 diabetes mellitus  1  0/3257 (0.00%)  1/3248 (0.03%) 
Musculoskeletal and connective tissue disorders     
Facial asymmetry  1  0/3257 (0.00%)  1/3248 (0.03%) 
Joint effusion  1  1/3257 (0.03%)  0/3248 (0.00%) 
Muscle haemorrhage  1  2/3257 (0.06%)  0/3248 (0.00%) 
Muscle spasms  1  1/3257 (0.03%)  0/3248 (0.00%) 
Musculoskeletal chest pain  1  1/3257 (0.03%)  0/3248 (0.00%) 
Myositis  1  1/3257 (0.03%)  0/3248 (0.00%) 
Pain in extremity  1  0/3257 (0.00%)  1/3248 (0.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder transitional cell carcinoma  1  1/3257 (0.03%)  0/3248 (0.00%) 
Breast cancer  1  0/3257 (0.00%)  1/3248 (0.03%) 
Colon neoplasm  1  1/3257 (0.03%)  0/3248 (0.00%) 
Colorectal adenocarcinoma  1  0/3257 (0.00%)  1/3248 (0.03%) 
Gastric cancer  1  0/3257 (0.00%)  1/3248 (0.03%) 
Lung adenocarcinoma  1  1/3257 (0.03%)  0/3248 (0.00%) 
Lung adenocarcinoma metastatic  1  0/3257 (0.00%)  1/3248 (0.03%) 
Lung neoplasm malignant  1  1/3257 (0.03%)  2/3248 (0.06%) 
Mediastinum neoplasm  1  0/3257 (0.00%)  1/3248 (0.03%) 
Mesothelioma  1  0/3257 (0.00%)  1/3248 (0.03%) 
Metastases to liver  1  0/3257 (0.00%)  1/3248 (0.03%) 
Metastases to lung  1  0/3257 (0.00%)  1/3248 (0.03%) 
Metastatic gastric cancer  1  0/3257 (0.00%)  1/3248 (0.03%) 
Myelodysplastic syndrome  1  1/3257 (0.03%)  0/3248 (0.00%) 
Ovarian neoplasm  1  0/3257 (0.00%)  1/3248 (0.03%) 
Prostate cancer  1  1/3257 (0.03%)  0/3248 (0.00%) 
Renal neoplasm  1  0/3257 (0.00%)  1/3248 (0.03%) 
Small cell lung cancer  1  0/3257 (0.00%)  1/3248 (0.03%) 
Waldenstrom's macroglobulinaemia  1  1/3257 (0.03%)  0/3248 (0.00%) 
Nervous system disorders     
Altered state of consciousness  1  1/3257 (0.03%)  0/3248 (0.00%) 
Aphasia  1  1/3257 (0.03%)  1/3248 (0.03%) 
Brain stem stroke  1  0/3257 (0.00%)  1/3248 (0.03%) 
Carotid artery stenosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Carotid sinus syndrome  1  1/3257 (0.03%)  1/3248 (0.03%) 
Cerebral artery embolism  1  0/3257 (0.00%)  1/3248 (0.03%) 
Cerebral infarction  1  1/3257 (0.03%)  1/3248 (0.03%) 
Cerebrovascular accident  1  2/3257 (0.06%)  3/3248 (0.09%) 
Cognitive disorder  1  0/3257 (0.00%)  1/3248 (0.03%) 
Dementia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Dizziness  1  1/3257 (0.03%)  1/3248 (0.03%) 
Embolic stroke  1  1/3257 (0.03%)  1/3248 (0.03%) 
Epilepsy  1  1/3257 (0.03%)  0/3248 (0.00%) 
Haemorrhage intracranial  1  0/3257 (0.00%)  1/3248 (0.03%) 
Hemiparesis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Hypercapnic coma  1  0/3257 (0.00%)  1/3248 (0.03%) 
Ischaemic cerebral infarction  1  1/3257 (0.03%)  0/3248 (0.00%) 
Ischaemic stroke  1  11/3257 (0.34%)  16/3248 (0.49%) 
Loss of consciousness  1  1/3257 (0.03%)  0/3248 (0.00%) 
Muscle contractions involuntary  1  1/3257 (0.03%)  0/3248 (0.00%) 
Neuropathy peripheral  1  1/3257 (0.03%)  0/3248 (0.00%) 
Presyncope  1  2/3257 (0.06%)  0/3248 (0.00%) 
Radiculopathy  1  1/3257 (0.03%)  0/3248 (0.00%) 
Seizure  1  2/3257 (0.06%)  0/3248 (0.00%) 
Somnolence  1  1/3257 (0.03%)  1/3248 (0.03%) 
Syncope  1  5/3257 (0.15%)  3/3248 (0.09%) 
Transient ischaemic attack  1  6/3257 (0.18%)  1/3248 (0.03%) 
Vascular encephalopathy  1  1/3257 (0.03%)  0/3248 (0.00%) 
Product Issues     
Device battery issue  1  1/3257 (0.03%)  0/3248 (0.00%) 
Device leakage  1  1/3257 (0.03%)  0/3248 (0.00%) 
Device malfunction  1  0/3257 (0.00%)  1/3248 (0.03%) 
Psychiatric disorders     
Acute psychosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Confusional state  1  2/3257 (0.06%)  1/3248 (0.03%) 
Delirium  1  2/3257 (0.06%)  2/3248 (0.06%) 
Delirium tremens  1  1/3257 (0.03%)  0/3248 (0.00%) 
Suicidal ideation  1  0/3257 (0.00%)  1/3248 (0.03%) 
Renal and urinary disorders     
Acute kidney injury  1  20/3257 (0.61%)  25/3248 (0.77%) 
Anuria  1  2/3257 (0.06%)  0/3248 (0.00%) 
Azotaemia  1  1/3257 (0.03%)  0/3248 (0.00%) 
Chronic kidney disease  1  4/3257 (0.12%)  3/3248 (0.09%) 
Haematuria  1  1/3257 (0.03%)  1/3248 (0.03%) 
Nephropathy toxic  1  0/3257 (0.00%)  6/3248 (0.18%) 
Nephrotic syndrome  1  1/3257 (0.03%)  1/3248 (0.03%) 
Oliguria  1  1/3257 (0.03%)  1/3248 (0.03%) 
Prerenal failure  1  1/3257 (0.03%)  0/3248 (0.00%) 
Renal artery stenosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Renal failure  1  10/3257 (0.31%)  16/3248 (0.49%) 
Renal impairment  1  13/3257 (0.40%)  9/3248 (0.28%) 
Renal mass  1  0/3257 (0.00%)  1/3248 (0.03%) 
Urinary retention  1  1/3257 (0.03%)  0/3248 (0.00%) 
Reproductive system and breast disorders     
Acquired phimosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Benign prostatic hyperplasia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  5/3257 (0.15%)  5/3248 (0.15%) 
Acute respiratory distress syndrome  1  1/3257 (0.03%)  1/3248 (0.03%) 
Acute respiratory failure  1  3/3257 (0.09%)  3/3248 (0.09%) 
Bronchitis chronic  1  0/3257 (0.00%)  1/3248 (0.03%) 
Bronchospasm  1  1/3257 (0.03%)  1/3248 (0.03%) 
Chronic obstructive pulmonary disease  1  5/3257 (0.15%)  7/3248 (0.22%) 
Dyspnoea  1  6/3257 (0.18%)  5/3248 (0.15%) 
Dyspnoea exertional  1  0/3257 (0.00%)  1/3248 (0.03%) 
Epistaxis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Haemothorax  1  1/3257 (0.03%)  0/3248 (0.00%) 
Hypercapnia  1  0/3257 (0.00%)  1/3248 (0.03%) 
Hypoxia  1  1/3257 (0.03%)  2/3248 (0.06%) 
Interstitial lung disease  1  1/3257 (0.03%)  1/3248 (0.03%) 
Lung infiltration  1  0/3257 (0.00%)  1/3248 (0.03%) 
Pleural effusion  1  5/3257 (0.15%)  2/3248 (0.06%) 
Pneumothorax  1  0/3257 (0.00%)  2/3248 (0.06%) 
Pulmonary cavitation  1  0/3257 (0.00%)  1/3248 (0.03%) 
Pulmonary embolism  1  5/3257 (0.15%)  7/3248 (0.22%) 
Pulmonary fibrosis  1  1/3257 (0.03%)  1/3248 (0.03%) 
Pulmonary hypertension  1  1/3257 (0.03%)  1/3248 (0.03%) 
Pulmonary mass  1  0/3257 (0.00%)  1/3248 (0.03%) 
Pulmonary oedema  1  3/3257 (0.09%)  2/3248 (0.06%) 
Respiratory acidosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Respiratory arrest  1  0/3257 (0.00%)  1/3248 (0.03%) 
Respiratory depression  1  0/3257 (0.00%)  1/3248 (0.03%) 
Respiratory distress  1  1/3257 (0.03%)  0/3248 (0.00%) 
Respiratory failure  1  7/3257 (0.21%)  10/3248 (0.31%) 
Skin and subcutaneous tissue disorders     
Diabetic foot  1  0/3257 (0.00%)  1/3248 (0.03%) 
Drug eruption  1  1/3257 (0.03%)  0/3248 (0.00%) 
Panniculitis  1  1/3257 (0.03%)  0/3248 (0.00%) 
Rash maculo-papular  1  0/3257 (0.00%)  1/3248 (0.03%) 
Skin ulcer  1  0/3257 (0.00%)  2/3248 (0.06%) 
Surgical and medical procedures     
Cardioversion  1  1/3257 (0.03%)  0/3248 (0.00%) 
Coronary artery bypass  1  1/3257 (0.03%)  0/3248 (0.00%) 
Toe amputation  1  0/3257 (0.00%)  1/3248 (0.03%) 
Vascular disorders     
Aortic aneurysm  1  0/3257 (0.00%)  1/3248 (0.03%) 
Aortic aneurysm rupture  1  1/3257 (0.03%)  0/3248 (0.00%) 
Aortic dissection  1  1/3257 (0.03%)  0/3248 (0.00%) 
Arterial stenosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Arteriosclerosis  1  0/3257 (0.00%)  2/3248 (0.06%) 
Arteriovenous fistula  1  0/3257 (0.00%)  1/3248 (0.03%) 
Deep vein thrombosis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Hypertension  1  1/3257 (0.03%)  3/3248 (0.09%) 
Hypertensive crisis  1  3/3257 (0.09%)  1/3248 (0.03%) 
Hypotension  1  14/3257 (0.43%)  9/3248 (0.28%) 
Hypovolaemic shock  1  0/3257 (0.00%)  1/3248 (0.03%) 
Iliac artery embolism  1  1/3257 (0.03%)  0/3248 (0.00%) 
Orthostatic hypotension  1  0/3257 (0.00%)  1/3248 (0.03%) 
Peripheral embolism  1  1/3257 (0.03%)  0/3248 (0.00%) 
Peripheral vascular disorder  1  0/3257 (0.00%)  1/3248 (0.03%) 
Phlebitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
Shock  1  1/3257 (0.03%)  0/3248 (0.00%) 
Subclavian steal syndrome  1  1/3257 (0.03%)  0/3248 (0.00%) 
Thrombophlebitis  1  0/3257 (0.00%)  1/3248 (0.03%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Serelaxin (RLX030) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1336/3257 (41.02%)   1277/3248 (39.32%) 
Blood and lymphatic system disorders     
Anaemia  1  48/3257 (1.47%)  47/3248 (1.45%) 
Cardiac disorders     
Angina pectoris  1  17/3257 (0.52%)  15/3248 (0.46%) 
Aortic valve incompetence  1  21/3257 (0.64%)  25/3248 (0.77%) 
Aortic valve stenosis  1  23/3257 (0.71%)  13/3248 (0.40%) 
Atrial fibrillation  1  46/3257 (1.41%)  45/3248 (1.39%) 
Bradycardia  1  23/3257 (0.71%)  22/3248 (0.68%) 
Cardiac failure  1  162/3257 (4.97%)  185/3248 (5.70%) 
Mitral valve incompetence  1  52/3257 (1.60%)  47/3248 (1.45%) 
Tricuspid valve incompetence  1  30/3257 (0.92%)  21/3248 (0.65%) 
Ventricular tachycardia  1  37/3257 (1.14%)  24/3248 (0.74%) 
Gastrointestinal disorders     
Abdominal pain  1  18/3257 (0.55%)  19/3248 (0.58%) 
Constipation  1  70/3257 (2.15%)  57/3248 (1.75%) 
Diarrhoea  1  44/3257 (1.35%)  52/3248 (1.60%) 
Nausea  1  59/3257 (1.81%)  51/3248 (1.57%) 
Vomiting  1  30/3257 (0.92%)  24/3248 (0.74%) 
General disorders     
Non-cardiac chest pain  1  12/3257 (0.37%)  20/3248 (0.62%) 
Pyrexia  1  31/3257 (0.95%)  41/3248 (1.26%) 
Infections and infestations     
Bronchitis  1  30/3257 (0.92%)  47/3248 (1.45%) 
Cystitis  1  18/3257 (0.55%)  7/3248 (0.22%) 
Pneumonia  1  17/3257 (0.52%)  22/3248 (0.68%) 
Urinary tract infection  1  58/3257 (1.78%)  68/3248 (2.09%) 
Investigations     
Blood creatinine increased  1  36/3257 (1.11%)  49/3248 (1.51%) 
Blood potassium decreased  1  15/3257 (0.46%)  20/3248 (0.62%) 
Blood pressure decreased  1  36/3257 (1.11%)  23/3248 (0.71%) 
Blood pressure systolic decreased  1  29/3257 (0.89%)  24/3248 (0.74%) 
Blood urea increased  1  24/3257 (0.74%)  25/3248 (0.77%) 
Metabolism and nutrition disorders     
Gout  1  16/3257 (0.49%)  28/3248 (0.86%) 
Hyperglycaemia  1  25/3257 (0.77%)  17/3248 (0.52%) 
Hyperkalaemia  1  40/3257 (1.23%)  36/3248 (1.11%) 
Hyperuricaemia  1  25/3257 (0.77%)  21/3248 (0.65%) 
Hypoglycaemia  1  29/3257 (0.89%)  22/3248 (0.68%) 
Hypokalaemia  1  263/3257 (8.07%)  241/3248 (7.42%) 
Hyponatraemia  1  19/3257 (0.58%)  13/3248 (0.40%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  25/3257 (0.77%)  21/3248 (0.65%) 
Back pain  1  22/3257 (0.68%)  26/3248 (0.80%) 
Muscle spasms  1  79/3257 (2.43%)  49/3248 (1.51%) 
Pain in extremity  1  27/3257 (0.83%)  32/3248 (0.99%) 
Nervous system disorders     
Dizziness  1  27/3257 (0.83%)  17/3248 (0.52%) 
Headache  1  74/3257 (2.27%)  92/3248 (2.83%) 
Psychiatric disorders     
Anxiety  1  16/3257 (0.49%)  30/3248 (0.92%) 
Confusional state  1  25/3257 (0.77%)  28/3248 (0.86%) 
Insomnia  1  42/3257 (1.29%)  48/3248 (1.48%) 
Renal and urinary disorders     
Acute kidney injury  1  35/3257 (1.07%)  34/3248 (1.05%) 
Haematuria  1  20/3257 (0.61%)  20/3248 (0.62%) 
Renal failure  1  42/3257 (1.29%)  46/3248 (1.42%) 
Renal impairment  1  48/3257 (1.47%)  55/3248 (1.69%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  6/3257 (0.18%)  17/3248 (0.52%) 
Cough  1  41/3257 (1.26%)  36/3248 (1.11%) 
Dyspnoea  1  17/3257 (0.52%)  15/3248 (0.46%) 
Epistaxis  1  19/3257 (0.58%)  14/3248 (0.43%) 
Vascular disorders     
Hypertension  1  23/3257 (0.71%)  37/3248 (1.14%) 
Hypotension  1  69/3257 (2.12%)  58/3248 (1.79%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01870778     History of Changes
Other Study ID Numbers: CRLX030A2301
2013-001498-25 ( EudraCT Number )
First Submitted: June 3, 2013
First Posted: June 6, 2013
Results First Submitted: January 18, 2018
Results First Posted: March 30, 2018
Last Update Posted: March 30, 2018