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This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy, in approximately 45 Japanese AHF patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serelaxin 10 mcg/kg/Day | Experimental | Participants received 10 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. |
|
| Serelaxin 30 mcg/kg/Day | Experimental | Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. |
|
| Placebo | Placebo Comparator | Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serelaxin | Drug | Intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | From start of study treatment up to Day 5 (for AEs); From start of study treatment up to Day 14 (for SAEs) |
| Maximum Plasma Concentration (Cmax) of Serelaxin | Maximum plasma concentration (Cmax) was defined as the peak level of serelaxin, derived from plasma concentration-time data, using a non-compartmental model approach. | Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose) |
| Weight Adjusted Clearance (CL) of Serelaxin | 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. | Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose) |
| Concentration at Steady-state (Css) of Serelaxin | 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. | Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5 | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Seto | Aichi-ken | 489-8642 | Japan | ||
| Novartis Investigative Site |
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The study was conducted at 15 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Serelaxin 10 mcg/kg/Day | Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours. |
| FG001 | Serelaxin 30 mcg/kg/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Placebo |
|
| Baseline, 48 hours, Day 5 |
| Change From Baseline in Aldosterone Levels Through Day 14 | 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. | Baseline, Day 1, Day 2, Day 5, Day 14 |
| Change From Baseline in Cystatin-C Levels Through Day 14 | 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. | Baseline, Day 1, Day 2, Day 5, Day 14 |
| Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14 | 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. | Baseline, Day 1, Day 2, Day 5, Day 14 |
| Change From Baseline in NT-proBNP Levels Through Day 14 | 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. | Baseline, Day 1, Day 2, Day 5, Day 14 |
| Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14 | 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. | Baseline, Day 1, Day 2, Day 5, Day 14 |
| Fukuoka |
| Fukuoka |
| 810-0001 |
| Japan |
| Novartis Investigative Site | Iizuka | Fukuoka | 820-8505 | Japan |
| Novartis Investigative Site | Hiroshima | Hiroshima | 730-8518 | Japan |
| Novartis Investigative Site | Amagasaki | Hyōgo | 660-8550 | Japan |
| Novartis Investigative Site | Higashiibaraki-gun | Ibaraki | 311-3193 | Japan |
| Novartis Investigative Site | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 211-8533 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 231-8682 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 981-3107 | Japan |
| Novartis Investigative Site | Ueda | Nagano | 386-8610 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 534-0021 | Japan |
| Novartis Investigative Site | Sayama | Saitama | 350-1323 | Japan |
| Novartis Investigative Site | Komatsushimachō | Tokushima | 773-8502 | Japan |
| Novartis Investigative Site | Itabashi-ku | Tokyo | 173-8610 | Japan |
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
| FG002 | Placebo | Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours. |
| COMPLETED |
|
| NOT COMPLETED |
|
The analysis was performed on safety population defined as all randomized participants received any amount of study drug and had at least one post-baseline safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Serelaxin 10 mcg/kg/Day | Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours. |
| BG001 | Serelaxin 30 mcg/kg/Day | Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. |
| BG002 | Placebo | Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 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. | 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. | Posted | Number | participants | From start of study treatment up to Day 5 (for AEs); From start of study treatment up to Day 14 (for SAEs) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Maximum Plasma Concentration (Cmax) of Serelaxin | Maximum plasma concentration (Cmax) was defined as the peak level of serelaxin, derived from plasma concentration-time data, using a non-compartmental model approach. | 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. | Posted | Mean | Standard Deviation | nanogram(s)/milliliter (ng/mL) | Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose) |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Weight Adjusted Clearance (CL) of Serelaxin | 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. | 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. | Posted | Mean | Standard Deviation | mL/hr/kg | Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose) |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Concentration at Steady-state (Css) of Serelaxin | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5 | 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. | The analysis was performed in the full analysis set (FAS) population, defined as all participants who were randomized in the study. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline, 48 hours, Day 5 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Aldosterone Levels Through Day 14 | 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. | The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline, Day 1, Day 2, Day 5, Day 14 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cystatin-C Levels Through Day 14 | 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. | The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline, Day 1, Day 2, Day 5, Day 14 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14 | 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. | The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline, Day 1, Day 2, Day 5, Day 14 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in NT-proBNP Levels Through Day 14 | 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. | The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline, Day 1, Day 2, Day 5, Day 14 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14 | 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. | The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline, Day 1, Day 2, Day 5, Day 14 |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Serelaxin 10 mcg/kg/Day | Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours. | 1 | 16 | 10 | 16 | ||
| EG001 | Serelaxin 30 mcg/kg/Day | Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. | 3 | 15 | 9 | 15 | ||
| EG002 | Placebo | Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours. | 0 | 15 | 9 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA | Systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| METASTASES TO LYMPH NODES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| METASTASES TO PERITONEUM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| OESOPHAGEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| INFUSION SITE PAIN | General disorders | MedDRA | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| BACTERIAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BLOOD PRESSURE DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| BLOOD PRESSURE SYSTOLIC DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| RESTLESSNESS | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| GENITAL PAIN | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| VASCULITIS | Vascular disorders | MedDRA | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 -778 -8300 |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C577649 | serelaxin protein, human |
Not provided
Not provided
Not provided
| ≥ 65 years |
|
| Male |
|
| Title | Measurements |
|---|---|
|
| Death |
|
| Discontinuation due to AE(s) |
|
| Discontinuation due to SAE(s) |
|
| AEs requiring dose adjustment or interruption |
|
| AEs requiring additional therapy |
|
| AEs related to study drug |
|
|
|
|
| OG002 | Placebo | Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours. |
|
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