Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002781-39 | EudraCT Number |
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The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLX030 (serelaxin) | Experimental | Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8 |
|
| Placebo | Placebo Comparator | Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RLX030 (serelaxin) | Drug | RLX030 (serelaxin) was administered according to a weight-range adjusted dosing regimen at a nominal dose of 30 μg/kg/day as a continuous IV infusion for 48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Chronic Heart Failure (CHF) Who Develop Anti-serelaxin Antibodies at Any Time Following Repeat Administration of IV Continuous Infusions of Serelaxin Administered for up to 48 Hours in 16 Weeks | A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. A patient is considered antibody negative during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were negative. A patient's antibody status is considered to be undetermined during the study if it is not defined as positive or negative. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies After a Single Infusion of Serelaxin Over Time up to Week 16 | A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. Each time period is defined as the time frame from study drug initiation (or the visit if there is no infusion) to prior to study drug initiation of the next period (or the visit if no there is no infusion). n= The total number of subjects with evaluable antibody status during the defined period. |
Not provided
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 | Anaheim | California | 92801 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26583301 | Derived | Kumar VA, Wilson SS, Ayaz SI, Levy PD. Targeted biological therapies reach the heart: the case of serelaxin for heart failure. Drugs Today (Barc). 2015 Oct;51(10):591-7. doi: 10.1358/dot.2015.51.10.2386731. |
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A total of 323 patients were randomized to the serelaxin or placebo treatment in a 2:1 ratio. 2 patients from serelaxin were mis-randomized, hence 321 received study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | RLX030 (Serelaxin) | Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8 |
| FG001 | Placebo | Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Placebo | Drug | Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours. |
|
| Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16 |
| Antibody Titers in Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies (Neutralizing, Non-neutralizing or Both) at Any Time Following 3 Repeated Infusions and at Week 4, Week 8 and Week 12 | Week 4, Week 8, Week 12 |
| Percentage of Participants With Chronic Heart Failure With Positive Antibody Status Who Develop Non-neutralizing Anti-serelaxin Antibodies Following 3 Repeated Infusions (i.e. at Week 4, Week 8, and Week 12) | A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. n = the total number of subjects with evaluable antibody status after specified number of infusions | At Week 4, Week 8, Week 12 |
| Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions | Incidence rate of special interest, indicative of hypersensitivity reactions which occur during and after administration of repeated infusions of serelaxin relative to placebo in subjects with chronic heart failure is reported. Hypersensitivity reactions or infusion reactions can be headache, nausea, fever, chills, dizziness, flush, pruritus, chest and/or back pain. | 16 weeks |
| Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48) | Due to sparse PK sampling, AUC 0-48 hours was not analyzed. | pre-infusion and 8, 24 and 48 hours post each infusion. |
| Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css) | Concentration at steady state (Css) was estimated using C48 or C24 for patients who received the intended rate of infusion for at least 24hours. n: Number of patients with valid PK parameters available | pre-infusion and 24, 48 hours post each infusion |
| Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours | This analysis was not done due to sparse PK sampling. | 48 hours post each infusion |
| Pharmacokinetics of RLX030: Clearance of Serelaxin (CL) | Clearance (CL) was calculated using concentration at steady state (Css) and the actual delivered dose rate. n: Number of patients with valid PK parameters available within 48 hours post each infusion. | 48 hours post each infusion |
| Colorado Springs |
| Colorado |
| 80918 |
| United States |
| Novartis Investigative Site | Jacksonville | Florida | 32216 | United States |
| Novartis Investigative Site | South Miami | Florida | 33143 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55404 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55417 | United States |
| Novartis Investigative Site | Chapel Hill | North Carolina | 27599-7075 | United States |
| Novartis Investigative Site | Knoxville | Tennessee | 37920 | United States |
| Novartis Investigative Site | Richmond | Virginia | 23298-0050 | United States |
| Novartis Investigative Site | Geelong | 3220 | Australia |
| Novartis Investigative Site | Melbourne | VIC 3004 | Australia |
| Novartis Investigative Site | Brno-Bohunice | Czech Republic | 625 00 | Czechia |
| Novartis Investigative Site | Jihlava | 586 01 | Czechia |
| Novartis Investigative Site | Prague | 128 08 | Czechia |
| Novartis Investigative Site | Turku | Finland | 20521 | Finland |
| Novartis Investigative Site | Lübeck | Germany | 23562 | Germany |
| Novartis Investigative Site | Hanover | Lower Saxony | 30159 | Germany |
| Novartis Investigative Site | Berlin | State of Berlin | 10117 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Dresden | 01069 | Germany |
| Novartis Investigative Site | Frankfurt | 60488 | Germany |
| Novartis Investigative Site | Greifswald | 17475 | Germany |
| Novartis Investigative Site | Grünstadt | D-67269 | Germany |
| Novartis Investigative Site | Jena | 07740 | Germany |
| Novartis Investigative Site | Kiel | 24105 | Germany |
| Novartis Investigative Site | Magdeburg | 39112 | Germany |
| Novartis Investigative Site | Cortona | AR | 52044 | Italy |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Monza | MB | 20900 | Italy |
| Novartis Investigative Site | Vimercate | MI | 200059 | Italy |
| Novartis Investigative Site | Sneek | The Netherlands | 8601 ZR | Netherlands |
| Novartis Investigative Site | Groningen | Netherlands |
| Novartis Investigative Site | Rotterdam | 3000 CA | Netherlands |
| Novartis Investigative Site | Oslo | 0424 | Norway |
| Novartis Investigative Site | Târgu Mureş | Mureș County | 540136 | Romania |
| Novartis Investigative Site | Bucharest | Romania | 014461 | Romania |
| Novartis Investigative Site | Bucharest | 021659 | Romania |
| Novartis Investigative Site | Craiova | 200642 | Romania |
| Novartis Investigative Site | Sibiu | 550245 | Romania |
| Novartis Investigative Site | Moscow | 109469 | Russia |
| Novartis Investigative Site | Moscow | 117198 | Russia |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Seville | Andalusia | 41014 | Spain |
| Novartis Investigative Site | Villamartín | Cadiz | 11650 | Spain |
| Novartis Investigative Site | Madrid | Madrid | 28007 | Spain |
| Novartis Investigative Site | Madrid | Madrid | 28040 | Spain |
| Novartis Investigative Site | Stockholm | 141 86 | Sweden |
| Novartis Investigative Site | Diskapi / Ankara | 06110 | Turkey (Türkiye) |
| Novartis Investigative Site | Haydarpasa/Istanbul | 34668 | Turkey (Türkiye) |
| Novartis Investigative Site | Kocaeli | 41380 | Turkey (Türkiye) |
| Novartis Investigative Site | Meselik / Eskisehir | 26480 | Turkey (Türkiye) |
| Novartis Investigative Site | Sivas | 58140 | Turkey (Türkiye) |
| Full Analaysis Set (FAS) |
|
| Safety Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) - All patients to whom study treatment was assigned excluding patients who were mis-randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RLX030 (Serelaxin) | Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8 |
| BG001 | Placebo | Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8 |
| BG002 | 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 |
| |||||||||||||||
| 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 | Percentage of Participants With Chronic Heart Failure (CHF) Who Develop Anti-serelaxin Antibodies at Any Time Following Repeat Administration of IV Continuous Infusions of Serelaxin Administered for up to 48 Hours in 16 Weeks | A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. A patient is considered antibody negative during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were negative. A patient's antibody status is considered to be undetermined during the study if it is not defined as positive or negative. | Safety Set: All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment. In this reported analysis, patients with undetermined antibody status are excluded from analysis population | Posted | Number | 90% Confidence Interval | Percentage of participants | 16 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies After a Single Infusion of Serelaxin Over Time up to Week 16 | A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. Each time period is defined as the time frame from study drug initiation (or the visit if there is no infusion) to prior to study drug initiation of the next period (or the visit if no there is no infusion). n= The total number of subjects with evaluable antibody status during the defined period. | All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment. | Posted | Number | 90% Confidence Interval | Percentage of patients | Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Antibody Titers in Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies (Neutralizing, Non-neutralizing or Both) at Any Time Following 3 Repeated Infusions and at Week 4, Week 8 and Week 12 | Safety set:All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment | Posted | Mean | Standard Deviation | In international Units | Week 4, Week 8, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Chronic Heart Failure With Positive Antibody Status Who Develop Non-neutralizing Anti-serelaxin Antibodies Following 3 Repeated Infusions (i.e. at Week 4, Week 8, and Week 12) | A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. n = the total number of subjects with evaluable antibody status after specified number of infusions | All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment | Posted | Number | 90% Confidence Interval | Percentage of participants | At Week 4, Week 8, Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions | Incidence rate of special interest, indicative of hypersensitivity reactions which occur during and after administration of repeated infusions of serelaxin relative to placebo in subjects with chronic heart failure is reported. Hypersensitivity reactions or infusion reactions can be headache, nausea, fever, chills, dizziness, flush, pruritus, chest and/or back pain. | Safety set (SAF) - All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment. | Posted | Number | Participants | 16 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48) | Due to sparse PK sampling, AUC 0-48 hours was not analyzed. | Due to sparse PK sampling, this analysis was not done. | Posted | pre-infusion and 8, 24 and 48 hours post each infusion. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css) | Concentration at steady state (Css) was estimated using C48 or C24 for patients who received the intended rate of infusion for at least 24hours. n: Number of patients with valid PK parameters available | PK analysis set (PK) - All patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | ng/ml | pre-infusion and 24, 48 hours post each infusion |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours | This analysis was not done due to sparse PK sampling. | Due to sparse PK sampling, this analysis was not done. | Posted | 48 hours post each infusion |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of RLX030: Clearance of Serelaxin (CL) | Clearance (CL) was calculated using concentration at steady state (Css) and the actual delivered dose rate. n: Number of patients with valid PK parameters available within 48 hours post each infusion. | PK analysis set (PK) - All patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | mL/hr/kg | 48 hours post each infusion |
|
|
Not provided
Safety set (SAF) - All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RLX030 (Serelaxin) | Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8 | 30 | 212 | 65 | 212 | ||
| EG001 | Placebo | Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8 | 15 | 108 | 39 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | 18.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CHRONIC | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | 18.1 | Systematic Assessment |
| |
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | 18.1 | Systematic Assessment |
| |
| MEDICAL DEVICE SITE PAIN | General disorders | 18.1 | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | 18.1 | Systematic Assessment |
| |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | 18.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| DIARRHOEA INFECTIOUS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| EPIDIDYMITIS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| GANGRENE | Infections and infestations | 18.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| PERITONSILLAR ABSCESS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | 18.1 | Systematic Assessment |
| |
| PNEUMONIA STREPTOCOCCAL | Infections and infestations | 18.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| STREPTOCOCCAL SEPSIS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | 18.1 | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| VOCAL CORD PARALYSIS | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| ACUTE PSYCHOSIS | Psychiatric disorders | 18.1 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | 18.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | 18.1 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | 18.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| HYPERTENSIVE EMERGENCY | Vascular disorders | 18.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | 18.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | 18.1 | Systematic Assessment |
| |
| INFUSION SITE EXTRAVASATION | General disorders | 18.1 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | 18.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | 18.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | 18.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | 18.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | 18.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | 18.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | 18.1 | 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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Difference in percentage |
| -0.50 |
| 2-Sided |
| 90 |
| -10.38 |
| 9.38 |
| No |
| Superiority or Other |
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|