Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF (NCT NCT02007720)
NCT ID: NCT02007720
Last Updated: 2019-08-02
Results Overview
The trichotomous clinical composite endpoint of treatment success, treatment failure, or no change. Treatment success defined as improvement of dyspnea by Likert scale and at least 2 points improvement by at least 2 physician assessed signs and symptoms (orthopnea, rales edema, and jugular venous pulse) at Day 2; treatment failure defined as worsening heart failure, death, or re-hospitalization due to heart failure or renal failure through Day 5; no change defined as neither the criteria for treatment success nor the criteria for treatment failure was met through Day 5.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
876 participants
Primary outcome timeframe
through day 5
Results posted on
2019-08-02
Participant Flow
* patient randomized : participants who signed ICF (876 participants) * Full analyis set: participants who received at least one dose of study drug (870 participants) * safety set (858 participtants): participants who received at least one dose of study drug and completed at least one post baseline assessment
Participant milestones
| Measure |
Placebo
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
436
|
440
|
|
Overall Study
Full Analysis Set
|
433
|
437
|
|
Overall Study
Safety Set
|
426
|
432
|
|
Overall Study
COMPLETED
|
354
|
368
|
|
Overall Study
NOT COMPLETED
|
82
|
72
|
Reasons for withdrawal
| Measure |
Placebo
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
|
Overall Study
study terminated by sponsor
|
58
|
54
|
|
Overall Study
technical problem
|
4
|
2
|
|
Overall Study
patient followd less than 165 days
|
11
|
5
|
Baseline Characteristics
Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF
Baseline characteristics by cohort
| Measure |
Placebo
n=433 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=437 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
Total
n=870 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
full analysis set 870 participants
|
70.2 years
STANDARD_DEVIATION 13.86 • n=5 Participants
|
68.9 years
STANDARD_DEVIATION 14.40 • n=7 Participants
|
69.6 years
STANDARD_DEVIATION 14.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
268 Participants
n=5 Participants
|
290 Participants
n=7 Participants
|
558 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
418 Participants
n=5 Participants
|
420 Participants
n=7 Participants
|
838 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through day 5Population: Full analysis set (FAS) - All patients in the randomized population who were not misrandomized patients. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at the randomization
The trichotomous clinical composite endpoint of treatment success, treatment failure, or no change. Treatment success defined as improvement of dyspnea by Likert scale and at least 2 points improvement by at least 2 physician assessed signs and symptoms (orthopnea, rales edema, and jugular venous pulse) at Day 2; treatment failure defined as worsening heart failure, death, or re-hospitalization due to heart failure or renal failure through Day 5; no change defined as neither the criteria for treatment success nor the criteria for treatment failure was met through Day 5.
Outcome measures
| Measure |
Placebo
n=433 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=437 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.
Treatment Failure
|
36 Participants
|
18 Participants
|
|
Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.
No Change
|
314 Participants
|
333 Participants
|
|
Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.
Treatment Success
|
83 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: Through Day 5Population: Full analysis set (FAS) - All patients in the randomized population who were not misrandomized patients\*. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at the randomization
Results are given in terms of number of participants with at least one worsening heart failure (WHF) event through day 5 (pre-defined timeframe).
Outcome measures
| Measure |
Placebo
n=433 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=437 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Time to WHF
|
26 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Through Day 180Population: Full analysis set (FAS) - All patients in the randomized population who were not misrandomized patients\*. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at the randomization
analysis of time to CEC CV death through day 180 : results are given in terms of number of participants with CV death event through day 180 (pre-defined timeframe).
Outcome measures
| Measure |
Placebo
n=433 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=437 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Time to CV Death
|
27 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Through Day 180Population: Full analysis set (FAS) - All patients in the randomized population who were not misrandomized patients\*. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at the randomization
Results are given in terms of number of participants with all cause death event through day 180 (pre-defined timeframe).
Outcome measures
| Measure |
Placebo
n=433 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=437 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Time to All-cause Death
|
41 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Through Day 5Population: Full analysis set (FAS)with measure
Time to event is computed as the number of days from randomization to moderate or marked improvements in dyspnea by Likert scale
Outcome measures
| Measure |
Placebo
n=423 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=429 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Time to Moderate or Marked Improvements in Dyspnea by Likert Scale, Expressed in Days
|
1.327 days
Standard Deviation 1.4418
|
1.352 days
Standard Deviation 1.5071
|
SECONDARY outcome
Timeframe: Through Day 5Population: full analysis set with measure
Change from baseline in Dyspena by VAS-AUC through Day 5, expressed in mm-hours
Outcome measures
| Measure |
Placebo
n=429 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=432 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Dyspnea by VAS-AUC Changes
|
2284.6 mm-hours
Standard Deviation 2702.34
|
2358.2 mm-hours
Standard Deviation 2321.17
|
SECONDARY outcome
Timeframe: Up to day 30Population: full analysis set with measure
Length of stay will be defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day
Outcome measures
| Measure |
Placebo
n=432 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=437 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
|
3.2 days
Standard Deviation 5.13
|
2.5 days
Standard Deviation 4.26
|
SECONDARY outcome
Timeframe: Through Day 5Population: Full analysis set with measure
number of participants with renal dysfunction or in-hospital worsening of renal function through Day 5
Outcome measures
| Measure |
Placebo
n=418 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=416 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Renal Dysfunction and Prevention of Worsening of Renal Function
|
120 participants
|
59 participants
|
SECONDARY outcome
Timeframe: Through Day 180Time to event is computed as the number of days from randomization to re-hospitalization due to Heart Failure and renal impairment
Outcome measures
| Measure |
Placebo
n=433 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=82 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Time to Re-hospitalization Due to Heart Failure and Renal Impairment
|
87 days
|
82 days
|
SECONDARY outcome
Timeframe: Through Day 180Population: Full analysis set (FAS) - All patients in the randomized population who were not misrandomized patients\*. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at the randomization
Results are given in terms of number of participants with CV death or at least one re-hospitalization due to Heart Failure through day 180 (pre-defined timeframe).
Outcome measures
| Measure |
Placebo
n=433 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=437 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Time to CV Death or Re-hospitalization Due to Heart Failure/ Renal Failure
|
87 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Through Day 5Population: Full analysis set with measure
Results are given in terms of number of participants with at least one in-hospital worsening heart failure through day 5 (pre-defined timeframe). In-hospital worsening heart failure is defined by symptoms only, signs only, and both symptoms and signs.
Outcome measures
| Measure |
Placebo
n=433 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=437 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Time to In-hospital Worsening Heart Failure Through Day 5
death through day 5
|
1 Participants
|
1 Participants
|
|
Time to In-hospital Worsening Heart Failure Through Day 5
WHF through day 5 by both
|
20 Participants
|
9 Participants
|
|
Time to In-hospital Worsening Heart Failure Through Day 5
WHF through day 5 by symptoms
|
2 Participants
|
1 Participants
|
|
Time to In-hospital Worsening Heart Failure Through Day 5
WHF through day 5 by signs
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Day 5Population: full analysis set with measure
Number of patients reported with use of loop diuretic and vasoactive agents from randomization through Day 5
Outcome measures
| Measure |
Placebo
n=432 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=437 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Use of Loop Diuretic and Vasoactive Agents
|
58 participants
|
49 participants
|
SECONDARY outcome
Timeframe: Day 2 and Day 5Population: The data was not collected, and analysis not performed, as the trial was terminated prematurely
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.To evaluate the safety and tolerability of intravenous serelaxin in AHF patients, number of patients with total adverse events, serious adverse events and death will be analyzed.
Outcome measures
| Measure |
Placebo
n=433 Participants
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Serelaxin
n=437 Participants
Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
|
|---|---|---|
|
Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.
number of participants with AE
|
253 Participants
|
219 Participants
|
|
Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.
number of participants with SAE
|
50 Participants
|
37 Participants
|
|
Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.
number of patients with death
|
41 Participants
|
34 Participants
|
Adverse Events
RLX030
Serious events: 37 serious events
Other events: 65 other events
Deaths: 34 deaths
Placebo
Serious events: 50 serious events
Other events: 82 other events
Deaths: 41 deaths
Total
Serious events: 87 serious events
Other events: 147 other events
Deaths: 75 deaths
Serious adverse events
| Measure |
RLX030
n=432 participants at risk
RLX030
|
Placebo
n=426 participants at risk
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Total
n=858 participants at risk
Total
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.47%
2/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Cardiac arrest
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Cardiac failure
|
0.69%
3/432 • Through study completion, an average of 3 years
AE additional description
|
1.4%
6/426 • Through study completion, an average of 3 years
AE additional description
|
1.0%
9/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.47%
2/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.47%
2/426 • Through study completion, an average of 3 years
AE additional description
|
0.35%
3/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Coronary artery disease
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Coronary artery stenosis
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Myocardial ischaemia
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Ventricular fibrillation
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.47%
2/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
General disorders
Death
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
General disorders
Infusion site thrombosis
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
General disorders
Non-cardiac chest pain
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
General disorders
Sudden cardiac death
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Acinetobacter infection
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Bronchitis
|
0.46%
2/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Cellulitis
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Influenza
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Medical device site infection
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Pneumonia
|
1.4%
6/432 • Through study completion, an average of 3 years
AE additional description
|
1.6%
7/426 • Through study completion, an average of 3 years
AE additional description
|
1.5%
13/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Sepsis
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Septic shock
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Serratia sepsis
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.47%
2/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Investigations
Blood pressure decreased
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Gout
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.47%
2/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.47%
2/426 • Through study completion, an average of 3 years
AE additional description
|
0.35%
3/858 • Through study completion, an average of 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Nervous system disorders
Cerebral infarction
|
0.46%
2/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.35%
3/858 • Through study completion, an average of 3 years
AE additional description
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.47%
2/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Nervous system disorders
Partial seizures
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Nervous system disorders
Presyncope
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Renal and urinary disorders
Acute kidney injury
|
0.69%
3/432 • Through study completion, an average of 3 years
AE additional description
|
0.70%
3/426 • Through study completion, an average of 3 years
AE additional description
|
0.70%
6/858 • Through study completion, an average of 3 years
AE additional description
|
|
Renal and urinary disorders
Azotaemia
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.70%
3/426 • Through study completion, an average of 3 years
AE additional description
|
0.35%
3/858 • Through study completion, an average of 3 years
AE additional description
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.47%
2/426 • Through study completion, an average of 3 years
AE additional description
|
0.23%
2/858 • Through study completion, an average of 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.46%
2/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.35%
3/858 • Through study completion, an average of 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.46%
2/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.35%
3/858 • Through study completion, an average of 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Vascular disorders
Hypotension
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.47%
2/426 • Through study completion, an average of 3 years
AE additional description
|
0.35%
3/858 • Through study completion, an average of 3 years
AE additional description
|
|
Vascular disorders
Hypovolaemic shock
|
0.23%
1/432 • Through study completion, an average of 3 years
AE additional description
|
0.00%
0/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/432 • Through study completion, an average of 3 years
AE additional description
|
0.23%
1/426 • Through study completion, an average of 3 years
AE additional description
|
0.12%
1/858 • Through study completion, an average of 3 years
AE additional description
|
Other adverse events
| Measure |
RLX030
n=432 participants at risk
RLX030
|
Placebo
n=426 participants at risk
Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
|
Total
n=858 participants at risk
Total
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
3.2%
14/432 • Through study completion, an average of 3 years
AE additional description
|
5.2%
22/426 • Through study completion, an average of 3 years
AE additional description
|
4.2%
36/858 • Through study completion, an average of 3 years
AE additional description
|
|
Gastrointestinal disorders
Constipation
|
5.3%
23/432 • Through study completion, an average of 3 years
AE additional description
|
7.0%
30/426 • Through study completion, an average of 3 years
AE additional description
|
6.2%
53/858 • Through study completion, an average of 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.1%
35/432 • Through study completion, an average of 3 years
AE additional description
|
9.2%
39/426 • Through study completion, an average of 3 years
AE additional description
|
8.6%
74/858 • Through study completion, an average of 3 years
AE additional description
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However Novartis does not prohibit any inverstigator 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