| Primary | Mean Total Visualization Score of Qualitative Endocardial Border Delineation (EBD) of the 12 Segments of the Left Ventricle (LV) Wall in Standard Apical 4-chamber (A4C) and Apical 2-chamber (A2C) | Visualization of each of the 12 segments of the LV wall in standard A4C and A2C views were measured by the qualitative EBD visualization scale: score 0 =no visualization of the LV endocardial border; 1 =poor visualization; 2 =fair visualization; 3 =good/optimal visualization. The total LV EBD score was calculated as the sum of the individual scores assigned to each of the 12 LV wall segment and the total score ranged from 0 (no visualization of the LV endocardial border) to 36 (good/optimal visualization). A higher score indicated better visualization. The total score of qualitative EBD visualization scale were reported by reader (independent blinded), non-contrast and dose levels. | PP population consisted of all participants who had available non-contrast harmonic images and OPTISON-enhanced echocardiographic images, irrespective of the quality of CE-echo and who did not have an important protocol deviation impacting study primary endpoint. Each participant underwent an echocardiographic procedure first without contrast administration, then intravenous bolus injection of OPTISON. Here, "Number Analyzed" signifies participants who were evaluable for specified categories. | Posted | | Mean | Standard Deviation | score on a scale | | Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. | | OG001 | Body Weight Group >40 kg: OPTISON | Participants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level. |
| | | Title | Denominators | Categories |
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| Reader 1: Non-contrast | - ParticipantsOG0007
- ParticipantsOG00123
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1 | Paired t-test | | 0.0008 | | Mean Difference (Net) | 16.2 | Standard Deviation | 5.46 | 2-Sided | 95 | 10.44 | 21.89 | | | | | Other | | | | Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that starts or worsens at or after the time of first dosing of OPTISON. | The Safety population consisted of all enrolled participants who received >=1 dose of OPTISON in the study. | Posted | | Count of Participants | | Participants | | 0- 72 hours | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. | | OG001 | Body Weight Group >40 kg: OPTISON | Participants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level. |
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| Secondary | Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic and diastolic blood pressure were measured from the arm contra-lateral to the site of OPTISON administration whenever possible and before measurement, participants rested for at least 5 minutes (if possible). | The Safety population consisted of all enrolled participants who received >=1 dose of OPTISON in the study. Here, "Number Analyzed" signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. | | OG001 | Body Weight Group >40 kg: OPTISON | Participants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level. |
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| Secondary | Change From Baseline in Heart Rate | Before heart rate was measured, participants rested for at least 5 minutes (if possible). | The Safety population consisted of all enrolled participants who received >=1 dose of OPTISON in the study. Here, "Number Analyzed" signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. | | OG001 | Body Weight Group >40 kg: OPTISON | Participants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level. |
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| Secondary | Change From Baseline in Respiratory Rate | Before respiratory rate was measured, participants rested for at least 5 minutes (if possible). | The Safety population consisted of all enrolled participants who received >=1 dose of OPTISON in the study. Here, "Number Analyzed" signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | breaths per minute | | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. | | OG001 | Body Weight Group >40 kg: OPTISON | Participants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level. |
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| Secondary | Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry | Oxygen saturation was measured by pulse oximetry. Before oxygen saturation was measured, participants rested for at least 5 minutes (if possible). | The Safety population consisted of all enrolled participants who received >=1 dose of OPTISON in the study. Here, "Number Analyzed" signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | percentage of oxygen saturation | | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. | | OG001 | Body Weight Group >40 kg: OPTISON | Participants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level. |
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| Secondary | Number of Participants With Clinically Significant Abnormality in Physical Examination Findings | Participants underwent assessments including general appearance, respiratory, cardiovascular and neurological (motor function, level of consciousness, sensory function) examination. Any abnormal clinically significant physical examination findings were based on investigator decision. | The Safety population consisted of all enrolled participants who received >=1 dose of OPTISON in the study. | Posted | | Count of Participants | | Participants | | From first dose (Day 1) of study drug to 60 minutes post last dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. | | OG001 | Body Weight Group >40 kg: OPTISON | Participants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level. |
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| Secondary | Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters | Change from baseline in PR, QRS, QT, Bazett's formula corrected QT (QTcB), Fridericia's formula corrected QT (QTcF) and RR intervals expressed in millisecond (ms) were reported. | The Safety population consisted of all enrolled participants who received >=1 dose of OPTISON in the study. | Posted | | Mean | Standard Deviation | milliseconds (ms) | | Baseline (pre-dose), and at 10 and 30 minutes post last dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. | | OG001 | Body Weight Group >40 kg: OPTISON | Participants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level. |
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| Secondary | Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity | LVO peak contrast intensity was determined by readers (independent blinded) using a categorical scale as None, Low, Medium, High or Blooming, where, None = Absence of contrast signal; Low = Limited capacity to make a diagnostic assessment; Presence of contrast signal does not improve diagnostic interpretability to a great degree; Medium = Good capacity to make a diagnostic assessment; Contrast signal facilitates diagnostic interpretability to a good degree; High = Optimal capacity to make a diagnostic assessment; Contrast signal facilitates diagnostic interpretability to a high degree; Blooming = Oversaturation of the signal disrupts diagnostic interpretability. Tissue boundaries become challenging to delineate. There may be excessive acoustic shadowing in the far-field of the image. Number of participants by degree of LVO assessed by visual peak contrast intensity was presented by readers and dose levels. | PP population consisted of all participants who had available non-contrast harmonic images and OPTISON-enhanced echocardiographic images, irrespective of the quality of CE-echo and who did not have an important protocol deviation impacting study primary endpoint. Here, "Number Analyzed" signifies participants who were evaluable for specified categories. | Posted | | Count of Participants | | Participants | | Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. |
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| Secondary | Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling | Peak LV contrast filling for LVO was categorized as: 0 = none (0 percent [%] filling); 1 = faint (around 33% filling); 2 = intermediate (around 67% filling); 3 = full (100% filling) and data were presented by readers (independent blinded) and dose levels. | PP population consisted of all participants who had available non-contrast harmonic images and OPTISON-enhanced echocardiographic images, irrespective of the quality of CE-echo and who did not have an important protocol deviation impacting study primary endpoint. Here, "Number Analyzed" signifies participants who were evaluable for specified categories. | Posted | | Count of Participants | | Participants | | Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. | | OG001 | Body Weight Group >40 kg: OPTISON | |
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| Secondary | Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber | Contrast enhancement duration was determined from the time the contrast appeared in the LV to the time the contrast almost dissipated from the left chamber. 3 independent blinded reader performed evaluation. | PP population consisted of all participants who had available non-contrast harmonic images and OPTISON-enhanced echocardiographic images, irrespective of the quality of CE-echo and who did not have an important protocol deviation impacting study primary endpoint. Here, "Number Analyzed" signifies participants who were evaluable for specified categories. | Posted | | Count of Participants | | Participants | | Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. | | OG001 | Body Weight Group >40 kg: OPTISON | Participants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level. |
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| Secondary | Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images | Diagnostic confidence for the assessment of LV EBD and wall motion was scored for non-contrast and OPTISON-enhanced echocardiographic acquisitions separately using a 4-point scale which ranged from ranged 0 to 4, where 0 = no confidence, 1 = low confidence, 2 = moderate confidence, 3 = high confidence. A higher score indicates better confidence level. Data were presented by reader (independent blinded), non-contrast and dose levels. | PP population consisted of all participants who had available non-contrast harmonic images and OPTISON-enhanced echocardiographic images, irrespective of the quality of CE-echo and who did not have an important protocol deviation impacting study primary endpoint. Each participants underwent an echocardiographic procedure first without contrast administration, then intravenous bolus injection of OPTISON. Here, "Number Analyzed" signifies participants who were evaluable for specified categories. | Posted | | Count of Participants | | Participants | | Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. |
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| Secondary | Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography | Diagnostic confidence for the evaluation of LVEF was calculated using the formula: (end diastole volume - end systole volume)/(end diastole volume) was scored for non-contrast and OPTISON-enhanced echocardiographic acquisitions separately using a 4-point scale which ranged from 0 to 3, where 0 = no confidence, 1 = low confidence, 2 = moderate confidence, 3 = high confidence. A higher score indicates better confidence level. Data were presented by reader (independent blinded), non-contrast and dose levels. | PP population consisted of all participants who had available non-contrast harmonic images and OPTISON-enhanced echocardiographic images, irrespective of the quality of CE-echo and who did not have an important protocol deviation impacting study primary endpoint. Each participants underwent an echocardiographic procedure first without contrast administration, then intravenous bolus injection of OPTISON. Here, "Number Analyzed" signifies participants who were evaluable for specified categories. | Posted | | Count of Participants | | Participants | | Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer | | | | ID | Title | Description |
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| OG000 | Body Weight Group <=40 kg: OPTISON | Participants with body weight >=20 to <=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight >28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. |
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