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| ID | Type | Description | Link |
|---|---|---|---|
| JNS004-JPN-02 |
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The purpose of this exploratory study is to assess the efficacy and safety of nesiritide in participants with acute (a quick and severe form of illness in its early stage) heart failure (when the heart inadequately pumps blood through the body) including acute exacerbation of chronic (lasting a long time) heart failure, administered intravenous (into a vein) bolus (a large amount) followed by intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle).
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), multi-center (when more than 1 hospital or medical school team work on a medical research study), randomized (study medication assigned by chance), stepwise, bolus plus intravenous infusion, fixed-flexible (arbitrary dose titration [slow increase in drug dosage, guided by participant's responses]) study. The study consists of 3 periods: Observation period (from the time of obtaining consent to the start of study treatment), Treatment period, and Follow-up period (from 24 hours after the initiation of study treatment [discontinuation] to 30 days after the initiation of study treatment). The participants will be randomly assigned to 1 of the following 3 treatment groups: 2+0.005 group, 1+0.01 group and 2+0.01 group. The treatment period consists of treatment with bolus injection (over 1 minute) followed by intravenous infusion (over 24 hours: Period 1 [fixed-dose period] of 3 hours and Period 2 [flexible-dose period] of 21 hours).The study will be conducted stepwise and hence, initially participants will be randomly assigned to 1 of the following 2 groups: 1+0.01 group and 2+0.005 group. Participants will receive nesiritide at an initial dose of 0.005 or 0.01 microgram per kilogram per minute (mcg/kg/min), and the dose escalation of 0.005 mcg/kg/min per dose will be conducted every 3 hours up to maximum of 0.03 mcg/kg/min in Period 2. Safety data of at least 5 participants will be assessed for each group, and after confirming the safety of 2 groups, the participants will be assigned to third group of nesiritide 2 microgram per kilogram (mcg/kg) +0.01 mcg/kg/min. Then participants will be followed up to a maximum of 30 days after the initiation of study treatment, in follow-up period. Participants will primarily be evaluated for the effect of nesiritide on hemodynamic parameters such as pulmonary capillary wedge pressure (PCWP), or if it is unmeasurable then it will be complemented with pulmonary arterial diastolic pressure (PADP). Participants' safety will also be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nesiritide (1+0.01) | Experimental | Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 15.4 to 35.2 mcg/kg. |
|
| Nesiritide (2+0.005) | Experimental | Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 9.2 to 31.7 mcg/kg. |
|
| Nesiritide (2+0.01) | Experimental | Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 16.4 to 36.2 mcg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nesiritide (1+0.01) | Drug | Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 15.4 to 35.2 mcg/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours | Change in PCWP was unmeasurable, therefore it was complemented with PADP. PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. | Baseline and 3 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | The MRAP was a measured hemodynamic parameter. MRAP was measured using a Swan-Ganz catheter. | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour |
| Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amagasaki | Japan | |||||
67 participants provided consent, out of these 61 participants were assigned to the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nesiritide (1+ 0.01) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg. |
| FG001 | Nesiritide (2+0.005) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg. |
| FG002 | Nesiritide (2+0.01) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period I |
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| Period II |
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The per protocol set (PPS) included all participants who met the principal criteria for eligibility, received at least 1 dose of study medication and had one efficacy assessment after randomization except those participants who had significant protocol deviations
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| ID | Title | Description |
|---|---|---|
| BG000 | Nesiritide (1+ 0.01) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics were analysed for the per protocol set (PPS). The PPS included all participants who met the principal criteria for eligibility, received at least 1 dose of study medication and had 1 efficacy assessment after randomization except those participants who had significant protocol deviations. |
| 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 | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours | Change in PCWP was unmeasurable, therefore it was complemented with PADP. PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. | The per protocol set (PPS) included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline and 3 Hours |
|
Baseline up to 30 days
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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 | Nesiritide (1+ 0.01) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager | Clinical Science Initiative Dept. Janssen Pharmaceutical K.K./ Tokyo Japan | +81.3.4411.5653 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020097 | Natriuretic Peptide, Brain |
| ID | Term |
|---|---|
| D045265 | Natriuretic Peptides |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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|
| Nesiritide (2+0.005) | Drug | Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 9.2 to 31.7 mcg/kg. |
|
| Nesritide (2+0.01) | Drug | Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 16.4 to 36.2 mcg/kg. |
|
The PASP was a measured hemodynamic parameters. PASP was assessed by Swan-Ganz catheter. |
| Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
| Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PADP was a measured hemodynamic parameter. Normal range of PADP is 8 to 15 millimeters of mercury (mmHg). PADP was assessed by Swan-Ganz catheter. | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
| Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The MPAP was a measured hemodynamic parameter. MPAP was measured using a Swan-Ganz catheter. | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
| Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PCWP was a measured hemodynamic parameter. It was the blood pressure, recorded after wedging a catheter in a small pulmonary artery; believed to reflect the pressure in the pulmonary capillaries. It was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
| Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The CO was a measured cardiopulmonary hemodynamic parameter. It is the volume of blood expelled by the ventricles of the heart with each beat. It was calculated as the product of stroke volume (output of either ventricle per heartbeat) and the number of beats per minute. Cardiac output is commonly measured by the thermodilution technique. | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
| Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | The MBP was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. MBP was calculated as sum of diastolic blood pressure (DBP) and (0.33*[SBP-DBP]) | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour |
| Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The CI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. CI was calculated by dividing CO and body surface area. | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
| Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The SV was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. SV was calculated by dividing CO and heart rate (HR). | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
| Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The SVI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA). | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
| Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | The SVR was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. SVR was calculated by dividing (80*[MBP-MRAP]) and CO. | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour |
| Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PVR (force that opposes the flow of blood through a vascular bed) was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. PVR was calculated by dividing (80*[MPAP-PCWP]) and CO. | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
| Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Assessment of Dyspnea (difficult or labored breathing) was done using Borg scale. It is a 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all; 0.5=very very slight (just noticeable); 1=very slight; 2=slight; 3=moderate; 4=somewhat severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum. | Baseline, 1 h and 24 h |
| Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | Assessment of Dyspnea was done using Likert scale. It is a 7-point scale where following scores stands for severity of dyspnea: 1=markedly better; 2=moderately better; 3=minimally better; 4=no change; 5=minimally worse; 6=moderately worse and 7= markedly worse | 3, 6 and 24 hour |
| Number of Participants With Orthopnea | Assessment of dyspnea was done by measuring percentage of participants showing presence or absence of orthopnea (it is the sensation of breathlessness in the recumbent position, relieved by sitting or standing) symptoms | Baseline, 1 and 24 hour |
| Number of Participants With Oxygen Therapy | Assessment of dyspnea was done by measuring number of participants showing presence or absence of oxygen therapy. | Baseline,1 and 24 hour |
| Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | Assessment of dyspnea was done by measuring SpO2 via pulse oximetry, by making the participant lye quietly in the post anesthesia care unit (PACU) and breathing room air (RA) | Baseline, 1, 2, 3, 6, 9, 12, 15 and 24 hour |
| Assessment of Dyspnea Using Respiratory Rate | Assessment of dyspnea was done by measuring respiratory rate which is the number of times an organism breathes with the lungs (respiration) per unit time, usually per minute | Baseline, 1, 2, 3, 6, 9, 15 and 24 hour |
| Urinary Volume | The urinary volume was measured because nesiritide has a diuretic effect. Measurement of hour urine was done in the observation period and treatment period. 1-hour urine before treatment initiation was measured in the observation period. In the treatment period, 1-hour urine for period 1 and 3-hour urine for period 2 was measured. Urinary volume was recorded for participants without urethral catheterization having spontaneous micturition when needed. | Baseline, 3 and 24 hour |
| Chikushino-shi |
| Japan |
| Hiroshima | Japan |
| Ikoma | Japan |
| Komatsushima | Japan |
| Kumamoto | Japan |
| Moriyama | Japan |
| Osaka | Japan |
| Saitama | Japan |
| Tokyo | Japan |
| Yokohama | Japan |
| NOT COMPLETED |
|
|
| BG001 | Nesiritide (2+0.005) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg. |
| BG002 | Nesiritide (2+0.01) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | The PPS included all participants who met the principal criteria for eligibility, received at least 1 dose of study medication and had 1 efficacy assessment after randomization except those participants who had significant protocol deviations. | Count of Participants | Participants |
|
| OG001 | Nesiritide (2+0.005) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg. |
| OG002 | Nesiritide (2+0.01) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg. |
|
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| Secondary | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | The MRAP was a measured hemodynamic parameter. MRAP was measured using a Swan-Ganz catheter. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour |
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| Secondary | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PASP was a measured hemodynamic parameters. PASP was assessed by Swan-Ganz catheter. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
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| Secondary | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PADP was a measured hemodynamic parameter. Normal range of PADP is 8 to 15 millimeters of mercury (mmHg). PADP was assessed by Swan-Ganz catheter. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
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| Secondary | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The MPAP was a measured hemodynamic parameter. MPAP was measured using a Swan-Ganz catheter. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
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| Secondary | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PCWP was a measured hemodynamic parameter. It was the blood pressure, recorded after wedging a catheter in a small pulmonary artery; believed to reflect the pressure in the pulmonary capillaries. It was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
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| Secondary | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The CO was a measured cardiopulmonary hemodynamic parameter. It is the volume of blood expelled by the ventricles of the heart with each beat. It was calculated as the product of stroke volume (output of either ventricle per heartbeat) and the number of beats per minute. Cardiac output is commonly measured by the thermodilution technique. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Liter per minute | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
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| Secondary | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | The MBP was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. MBP was calculated as sum of diastolic blood pressure (DBP) and (0.33*[SBP-DBP]) | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour |
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| Secondary | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The CI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. CI was calculated by dividing CO and body surface area. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Liter per minute per meter^2 (l/min/m^2) | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
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| Secondary | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The SV was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. SV was calculated by dividing CO and heart rate (HR). | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | milliliter (ml) | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
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| Secondary | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The SVI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA). | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | milliliter per meter^2 | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
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| Secondary | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | The SVR was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. SVR was calculated by dividing (80*[MBP-MRAP]) and CO. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | dyne*second per centimeter^5 | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour |
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|
| Secondary | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PVR (force that opposes the flow of blood through a vascular bed) was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. PVR was calculated by dividing (80*[MPAP-PCWP]) and CO. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | dyne*second/centimeter^5 | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour |
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| Secondary | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Assessment of Dyspnea (difficult or labored breathing) was done using Borg scale. It is a 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all; 0.5=very very slight (just noticeable); 1=very slight; 2=slight; 3=moderate; 4=somewhat severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure. | Posted | Number | Participants | Baseline, 1 h and 24 h |
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| Secondary | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | Assessment of Dyspnea was done using Likert scale. It is a 7-point scale where following scores stands for severity of dyspnea: 1=markedly better; 2=moderately better; 3=minimally better; 4=no change; 5=minimally worse; 6=moderately worse and 7= markedly worse | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure. | Posted | Number | Participants | 3, 6 and 24 hour |
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| Secondary | Number of Participants With Orthopnea | Assessment of dyspnea was done by measuring percentage of participants showing presence or absence of orthopnea (it is the sensation of breathlessness in the recumbent position, relieved by sitting or standing) symptoms | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure. | Posted | Number | Participants | Baseline, 1 and 24 hour |
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| Secondary | Number of Participants With Oxygen Therapy | Assessment of dyspnea was done by measuring number of participants showing presence or absence of oxygen therapy. | The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point. | Posted | Number | Participants | Baseline,1 and 24 hour |
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| Secondary | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | Assessment of dyspnea was done by measuring SpO2 via pulse oximetry, by making the participant lye quietly in the post anesthesia care unit (PACU) and breathing room air (RA) | The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here,n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Percentage of SpO2 | Baseline, 1, 2, 3, 6, 9, 12, 15 and 24 hour |
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| Secondary | Assessment of Dyspnea Using Respiratory Rate | Assessment of dyspnea was done by measuring respiratory rate which is the number of times an organism breathes with the lungs (respiration) per unit time, usually per minute | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Breaths Per Minute (BrPM) | Baseline, 1, 2, 3, 6, 9, 15 and 24 hour |
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| Secondary | Urinary Volume | The urinary volume was measured because nesiritide has a diuretic effect. Measurement of hour urine was done in the observation period and treatment period. 1-hour urine before treatment initiation was measured in the observation period. In the treatment period, 1-hour urine for period 1 and 3-hour urine for period 2 was measured. Urinary volume was recorded for participants without urethral catheterization having spontaneous micturition when needed. | The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point. | Posted | Mean | Standard Deviation | Millliter | Baseline, 3 and 24 hour |
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| 3 |
| 21 |
| 18 |
| 21 |
| EG001 | Nesiritide (2+0.005) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg. | 3 | 20 | 16 | 20 |
| EG002 | Nesiritide (2+0.01) | Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg. | 4 | 19 | 17 | 19 |
| Renal failure acute | Renal and urinary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Cerebral infarction | Vascular disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Cerebral artery embolism | Vascular disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Anxiety disorder | Psychiatric disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Cholinergic syndrome | Nervous system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Supraventricular extrasystoles | Cardiac disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Peripheral circulatory failure | Vascular disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Glossoptosis | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Hepatic congestion | Hepatobiliary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Polyuria | Renal and urinary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Catheter site haemorrhage | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Catheter site pain | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Infusion site phlebitis | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Vessel puncture site haemorrhage | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood urine present | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood urea increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Eosinophil count increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Basophil count increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood albumin decreased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Laboratory test abnormal | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Protein total decreased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Pulmonary arterial wedge pressure increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Red blood cell count decreased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 11.1 | Non-systematic Assessment |
|
The disclosure restriction on PI is that the Sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the Sponsor requires.
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| Change at 0.5 hour (n=19,18,16) |
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| Change at 6 hour (n=12,17,12) |
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| Change at 9 hour (n=0,1,0) |
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| Change at 12 hour (n=10,17,12) |
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| Change at 15 hour (n=1,1,0) |
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| Change at 24 hour (n=9,17,10) |
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|
| Baseline:Score 1; at 1 hour:Score 0 |
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| Baseline:Score 1; at 1 hour:Score 1 |
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| Baseline:Score 1; at 1 hour:Score 2 |
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| Baseline:Score 2; at 1 hour:Score 0 |
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| Baseline:Score 2; at 1 hour:Score 0.5 |
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| Baseline:Score 2; at 1 hour:Score 1 |
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| Baseline:Score 2; at 1 hour:Score 2 |
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| Baseline:Score 3; at 1 hour:Score 1 |
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| Baseline:Score 3; at 1 hour:Score 2 |
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| Baseline:Score 3; at 1 hour:Score 3 |
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| Baseline:Score 4; at 1 hour:Score 3 |
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| Baseline:Score 4; at 1 hour:Score 4 |
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| Baseline:Score 5; at 1 hour:Score 3 |
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| Baseline:Score 5; at 1 hour:Score 4 |
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| Baseline:Score 5; at 1 hour:Score 5 |
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| Baseline:Score 6; at 1 hour:Score 1 |
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| Baseline:Score 6; at 1 hour:Score 3 |
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| Baseline:Score 7; at 1 hour:Score 0 |
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| Baseline:Score 7; at 1 hour:Score 2 |
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| Baseline:Score 7; at 1 hour:Score 3 |
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| Baseline:Score 7; at 1 hour:Score 7 |
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| Baseline:Score 8; at 1 hour:Score 3 |
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| Baseline:Score 9; at 1 hour:Score 3 |
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| Baseline:Score 9; at 1 hour:Score 4 |
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| Baseline:Score 10; at 1 hour:Score 4 |
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| Baseline:Score 0; at 24 hour:Score 0 |
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| Baseline:Score 0; at 24 hour:Score 1 |
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| Baseline:Score 0.5; at 24 hour:Score 1 |
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| Baseline:Score 1; at 24 hour:Score 0 |
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| Baseline:Score 1; at 24 hour:Score 1 |
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| Baseline:Score 2; at 24 hour:Score 0 |
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| Baseline:Score 2; at 24 hour:Score 0.5 |
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| Baseline:Score 2; at 24 hour:Score 1 |
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| Baseline:Score 2; at 24 hour:Score 2 |
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| Baseline:Score 3; at 24 hour:Score 0 |
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| Baseline:Score 3; at 24 hour:Score 0.5 |
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| Baseline:Score 3; at 24 hour:Score 1 |
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| Baseline:Score 3; at 24 hour:Score 2 |
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| Baseline:Score 4; at 24 hour:Score 0 |
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| Baseline:Score 4; at 24 hour:Score 0.5 |
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| Baseline:Score 4; at 24 hour:Score 1 |
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| Baseline:Score 4; at 24 hour:Score 3 |
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| Baseline:Score 5; at 24 hour:Score 0 |
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| Baseline:Score 5; at 24 hour:Score 1 |
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| Baseline:Score 5; at 24 hour:Score 2 |
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| Baseline:Score 6; at 24 hour:Score 0 |
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| Baseline:Score 6; at 24 hour:Score 3 |
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| Baseline:Score 7; at 24 hour:Score 0 |
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| Baseline:Score 7; at 24 hour:Score 1 |
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| Baseline:Score 7; at 24 hour:Score 3 |
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| Baseline:Score 7; at 24 hour:Score 4 |
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| Baseline:Score 8; at 24 hour:Score 1 |
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| Title | Measurements |
|---|---|
|
| At 3 hour: Score 3 |
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| At 3 hour: Score 4 |
|
| At 3 hour: Score 5 |
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| At 6 hour: Score 1 |
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| At 6 hour: Score 2 |
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| At 6 hour: Score 3 |
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| At 6 hour: Score 4 |
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| At 24 hour: Score 1 |
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| At 24 hour: Score 2 |
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| At 24 hour: Score 3 |
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| At 24 hour: Score 4 |
|
|
| Baseline: 'No'; at 1 hour 'No' |
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| Baseline: 'Yes'; at 24 hour 'Yes' |
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| Baseline: 'Yes'; at 24 hour 'No' |
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| Baseline: 'No'; at 24 hour 'No' |
|
|
| Baseline: 'Yes';at 24 hour 'Yes'(n=14,19,15) |
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| Baseline:'No';at 24 hour 'No'(n=14,19,15) |
|
|
| At 2 hour (n=19,20,17) |
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| At 3 hour (n=19,20,17) |
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| At 6 hour (n=13,15,17) |
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| At 9 hour (n=0,1,0) |
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| At 15 hour (n=2,1,0) |
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| At 24 hour (n=14,19,15) |
|
|
| At 2 hour (n= 19,20,17) |
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| At 3 hour (n= 19,20,17) |
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| At 6 hour (n= 13,15,17) |
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| At 9 hour (n= 0,1,0) |
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| At 15 hour (n=2,1,0) |
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| At 24 hour (n= 14,18,17) |
|
|
| At 24 hour (n=19,20,17) |
|