Study to Determine Safety and Dosage of OPTISON in Pediatric Participants

A Phase 4, Open-Label, Non-Randomized, Multicenter Study to Evaluate Safety and Efficacy of Intravenous Administration of OPTISON™ for Contrast- Enhanced Echocardiography in Pediatric Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03740997

Enrollment

Registered

2018-11-14

Start date

2020-12-01

Completion date

2023-03-30

Last updated

2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality

Keywords

Contrast-enhanced echocardiography (CE-ECHO), Transthoracic echocardiogram, Child, Left ventricular opacification (LVO), Left ventricular ejection fraction (LVEF), Left ventricular endocardial border delineation (LV EBD)

Brief summary

Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development

Interventions

DRUGOptison

Optison is administered intravenously

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

9 Years to 17 Years

Healthy volunteers

Inclusion criteria

* The participant was between ≥9 and \<18 years of age and weighs ≥20 kg. * The participant was clinically indicated to undergo a transthoracic echocardiogram. * The participant had a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized. * The participant was able to comply with study procedures. * A parent or legal guardian of the participant had signed and dated an informed consent form. * Post-menarchal female participants must have had a negative urine pregnancy test at screening and at pre-dose on the day of OPTISON administration. * Post-menarchal female participants must have been practicing abstinence, or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 30 days before being enrolled in the study

Exclusion criteria

* The participant was previously enrolled in this study. * The participant received an investigational medicinal product within 30 days before or is scheduled to receive one from time of entry into this study until completion of the follow-up period proposed for this study. * The participant had a known or suspected hypersensitivity to any of the components of OPTISON, blood, blood products, or albumin. * The participant had pulmonary hypertension or unstable cardiopulmonary conditions. * The participant had severe liver disease based on medical history. * The participant had a recent (\<6 months) neurological event. * The participant presented any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the participant or other reason that in the judgment of the investigator makes the participant unsuitable for participation in the study. * The participant was a pregnant or lactating female, or was a female of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test was also required).

Design outcomes

Primary

Measure	Time frame	Description
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)	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	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.

Secondary

Measure	Time frame	Description
Change From Baseline in Systolic and Diastolic Blood Pressure	Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1	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).
Change From Baseline in Heart Rate	Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1	Before heart rate was measured, participants rested for at least 5 minutes (if possible).
Change From Baseline in Respiratory Rate	Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1	Before respiratory rate was measured, participants rested for at least 5 minutes (if possible).
Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry	Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1	Oxygen saturation was measured by pulse oximetry. Before oxygen saturation was measured, participants rested for at least 5 minutes (if possible).
Number of Participants With Clinically Significant Abnormality in Physical Examination Findings	From first dose (Day 1) of study drug to 60 minutes post last dose on Day 1	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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	0- 72 hours	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.
Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	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	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.
Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	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	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.
Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	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	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.
Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	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	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.
Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	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	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.
Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	Baseline (pre-dose), and at 10 and 30 minutes post last dose on Day 1	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.

Countries

United States

Participant flow

Recruitment details

This study was conducted between 01 December 2020 to 30 March 2023 at 8 centers in the United States.

Pre-assignment details

A total 39 participants were enrolled into the study, of which 37 received OPTISON injections according to body weight (less than or equal to \[\<=40\] kilograms \[kg\] \[included participants with body weight more than or equal to \[\>=\] 20 to \<=28 kg and greater than \[\>\] 28 to \<=40 kg\] and \>40 kg). As pre planned in Statistical Analysis Plan, data were collected, analyzed and presented for two body weight categories (\<= 40 kg and \>40 kg) only in all sections of the result.

Participants by arm

Arm	Count
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.	8
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.	29
Total	37

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Participant was unable to complete study procedures	1	0
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Body Weight Group >40 kg: OPTISON	Total	Body Weight Group <=40 kg: OPTISON
Age, Continuous	14.3 years STANDARD_DEVIATION 2.09	13.4 years STANDARD_DEVIATION 2.56	10.4 years STANDARD_DEVIATION 1.6
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants	18 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants	18 Participants	5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	3 Participants	3 Participants	0 Participants
Race (NIH/OMB) More than one race	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants	4 Participants	0 Participants
Race (NIH/OMB) White	20 Participants	26 Participants	6 Participants
Sex: Female, Male Female	11 Participants	14 Participants	3 Participants
Sex: Female, Male Male	18 Participants	23 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 29
other Total, other adverse events	4 / 8	9 / 29
serious Total, serious adverse events	0 / 8	0 / 29

Outcome results

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.

Time frame: 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

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Body Weight Group <=40 kg: OPTISON	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)	Reader 1: OPTISON Dose Level 1	31.3 score on a scale	Standard Deviation 6.53
Body Weight Group <=40 kg: OPTISON	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)	Reader 2: Non-contrast	13.4 score on a scale	Standard Deviation 2.57
Body Weight Group <=40 kg: OPTISON	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)	Reader 1: Non-contrast	15.9 score on a scale	Standard Deviation 5.73
Body Weight Group <=40 kg: OPTISON	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)	Reader 2: OPTISON Dose Level 2	35.4 score on a scale	Standard Deviation 0.79
Body Weight Group <=40 kg: OPTISON	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)	Reader 3: Non-contrast	21.3 score on a scale	Standard Deviation 7.13
Body Weight Group <=40 kg: OPTISON	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)	Reader 1: OPTISON Dose Level 2	35.1 score on a scale	Standard Deviation 2.27
Body Weight Group <=40 kg: OPTISON	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)	Reader 3: OPTISON Dose Level 1	32.5 score on a scale	Standard Deviation 3.73
Body Weight Group <=40 kg: OPTISON	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)	Reader 3: OPTISON Dose Level 2	33.4 score on a scale	Standard Deviation 2.07
Body Weight Group <=40 kg: OPTISON	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)	Reader 2: OPTISON Dose Level 1	32.8 score on a scale	Standard Deviation 1.47
Body Weight Group >40 kg: OPTISON	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)	Reader 3: OPTISON Dose Level 2	28.3 score on a scale	Standard Deviation 8.41
Body Weight Group >40 kg: OPTISON	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)	Reader 2: OPTISON Dose Level 1	28.1 score on a scale	Standard Deviation 10.34
Body Weight Group >40 kg: OPTISON	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)	Reader 2: OPTISON Dose Level 2	29.7 score on a scale	Standard Deviation 10.1
Body Weight Group >40 kg: OPTISON	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)	Reader 3: OPTISON Dose Level 1	27.8 score on a scale	Standard Deviation 10.4
Body Weight Group >40 kg: OPTISON	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)	Reader 1: Non-contrast	10.0 score on a scale	Standard Deviation 7.02
Body Weight Group >40 kg: OPTISON	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)	Reader 1: OPTISON Dose Level 1	26.6 score on a scale	Standard Deviation 12.5
Body Weight Group >40 kg: OPTISON	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)	Reader 1: OPTISON Dose Level 2	28.6 score on a scale	Standard Deviation 10.36
Body Weight Group >40 kg: OPTISON	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)	Reader 2: Non-contrast	8.5 score on a scale	Standard Deviation 6.49
Body Weight Group >40 kg: OPTISON	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)	Reader 3: Non-contrast	12.5 score on a scale	Standard Deviation 9.56

Comparison: Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2p-value: <0.000195% CI: [15.45, 26.99]Paired t-test

Comparison: Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1p-value: 0.026895% CI: [2.02, 21.64]Paired t-test

Comparison: Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1p-value: 0.000895% CI: [10.44, 21.89]Paired t-test

Comparison: Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1p-value: <0.000195% CI: [11.11, 23.07]Paired t-test

Comparison: Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2p-value: 0.000295% CI: [13.28, 25.3]Paired t-test

Comparison: Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2p-value: <0.000195% CI: [13.47, 23.57]Paired t-test

Comparison: Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1p-value: <0.000195% CI: [16.62, 23.05]Paired t-test

Comparison: Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1p-value: <0.000195% CI: [14.16, 26.03]Paired t-test

Comparison: Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2p-value: <0.000195% CI: [19.44, 24.56]Paired t-test

Comparison: Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1p-value: <0.000195% CI: [9.45, 22.82]Paired t-test

Comparison: Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2p-value: 0.002895% CI: [6.04, 18.24]Paired t-test

Comparison: Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2p-value: <0.000195% CI: [10.04, 21.61]Paired t-test

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.

Time frame: Baseline (pre-dose), and at 10 and 30 minutes post last dose on Day 1

Population: The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	PR Interval: Change at 10 Minutes Post Last Dose	-2.5 milliseconds (ms)	Standard Deviation 4.14
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QTcB Interval: Change at 10 Minutes Post Last Dose	1.2 milliseconds (ms)	Standard Deviation 56.8
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	PR Interval: Change at 30 Minutes Post Last Dose	-3.0 milliseconds (ms)	Standard Deviation 6.97
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QRS Duration: Change at 10 Minutes Post Last Dose	-0.8 milliseconds (ms)	Standard Deviation 5.37
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QRS Duration: Change at 30 Minutes Post Last Dose	0.9 milliseconds (ms)	Standard Deviation 2.8
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QT Interval: Change at 10 Minutes Post Last Dose	-6.9 milliseconds (ms)	Standard Deviation 26.28
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QT Interval: Change at 30 Minutes Post Last Dose	-8.0 milliseconds (ms)	Standard Deviation 13.75
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QTcB Interval: Change at 30 Minutes Post Last Dose	-9.3 milliseconds (ms)	Standard Deviation 30.94
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QTcF Interval: Change at 10 Minutes Post Last Dose	-1.9 milliseconds (ms)	Standard Deviation 44.56
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QTcF Interval: Change at 30 Minutes Post Last Dose	-8.9 milliseconds (ms)	Standard Deviation 24.24
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	RR Interval: Change at 10 Minutes Post Last Dose	-20.5 milliseconds (ms)	Standard Deviation 138.34
Body Weight Group <=40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	RR Interval: Change at 30 Minutes Post Last Dose	1.6 milliseconds (ms)	Standard Deviation 72.95
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	RR Interval: Change at 10 Minutes Post Last Dose	15.9 milliseconds (ms)	Standard Deviation 60.56
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QT Interval: Change at 30 Minutes Post Last Dose	-1.9 milliseconds (ms)	Standard Deviation 23.78
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QTcB Interval: Change at 10 Minutes Post Last Dose	-3.8 milliseconds (ms)	Standard Deviation 39.57
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	PR Interval: Change at 10 Minutes Post Last Dose	-2.0 milliseconds (ms)	Standard Deviation 9.47
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QTcF Interval: Change at 30 Minutes Post Last Dose	-6.2 milliseconds (ms)	Standard Deviation 30.48
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	PR Interval: Change at 30 Minutes Post Last Dose	-0.1 milliseconds (ms)	Standard Deviation 10.26
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QTcB Interval: Change at 30 Minutes Post Last Dose	-8.6 milliseconds (ms)	Standard Deviation 36.21
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QRS Duration: Change at 10 Minutes Post Last Dose	-0.2 milliseconds (ms)	Standard Deviation 5.35
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	RR Interval: Change at 30 Minutes Post Last Dose	22.8 milliseconds (ms)	Standard Deviation 73.59
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QRS Duration: Change at 30 Minutes Post Last Dose	-0.4 milliseconds (ms)	Standard Deviation 4.05
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QTcF Interval: Change at 10 Minutes Post Last Dose	-2.5 milliseconds (ms)	Standard Deviation 33.58
Body Weight Group >40 kg: OPTISON	Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters	QT Interval: Change at 10 Minutes Post Last Dose	0.0 milliseconds (ms)	Standard Deviation 25.83

Secondary

Change From Baseline in Heart Rate

Before heart rate was measured, participants rested for at least 5 minutes (if possible).

Time frame: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Body Weight Group <=40 kg: OPTISON	Change From Baseline in Heart Rate	Change at 10 Minutes Post Last Dose	-3.1 beats per minute	Standard Deviation 7.9
Body Weight Group <=40 kg: OPTISON	Change From Baseline in Heart Rate	Change at 60 Minutes Post Last Dose	-3.8 beats per minute	Standard Deviation 15.69
Body Weight Group >40 kg: OPTISON	Change From Baseline in Heart Rate	Change at 10 Minutes Post Last Dose	-4.9 beats per minute	Standard Deviation 9.79
Body Weight Group >40 kg: OPTISON	Change From Baseline in Heart Rate	Change at 60 Minutes Post Last Dose	-2.1 beats per minute	Standard Deviation 11.31

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).

Time frame: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Body Weight Group <=40 kg: OPTISON	Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry	Change at 10 Minutes Post Last Dose	0.0 percentage of oxygen saturation	Standard Deviation 1.2
Body Weight Group <=40 kg: OPTISON	Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry	Change at 60 Minutes Post Last Dose	-0.5 percentage of oxygen saturation	Standard Deviation 2.07
Body Weight Group >40 kg: OPTISON	Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry	Change at 10 Minutes Post Last Dose	0.1 percentage of oxygen saturation	Standard Deviation 1.19
Body Weight Group >40 kg: OPTISON	Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry	Change at 60 Minutes Post Last Dose	-0.2 percentage of oxygen saturation	Standard Deviation 1.32

Secondary

Change From Baseline in Respiratory Rate

Before respiratory rate was measured, participants rested for at least 5 minutes (if possible).

Time frame: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Body Weight Group <=40 kg: OPTISON	Change From Baseline in Respiratory Rate	Change at 10 Minutes Post Last Dose	-0.8 breaths per minute	Standard Deviation 3.99
Body Weight Group <=40 kg: OPTISON	Change From Baseline in Respiratory Rate	Change at 60 Minutes Post Last Dose	-0.8 breaths per minute	Standard Deviation 1.49
Body Weight Group >40 kg: OPTISON	Change From Baseline in Respiratory Rate	Change at 60 Minutes Post Last Dose	-1.5 breaths per minute	Standard Deviation 4.3
Body Weight Group >40 kg: OPTISON	Change From Baseline in Respiratory Rate	Change at 10 Minutes Post Last Dose	-0.2 breaths per minute	Standard Deviation 3.71

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).

Time frame: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Body Weight Group <=40 kg: OPTISON	Change From Baseline in Systolic and Diastolic Blood Pressure	Systolic Blood Pressure: Change at 10 Minutes Post Last Dose	-3.3 millimeter of mercury (mmHg)	Standard Deviation 8.21
Body Weight Group <=40 kg: OPTISON	Change From Baseline in Systolic and Diastolic Blood Pressure	Diastolic Blood Pressure: Change at 60 Minutes Post Last Dose	-1.8 millimeter of mercury (mmHg)	Standard Deviation 4.65
Body Weight Group <=40 kg: OPTISON	Change From Baseline in Systolic and Diastolic Blood Pressure	Systolic Blood Pressure: Change at 60 Minutes Post Last Dose	-4.8 millimeter of mercury (mmHg)	Standard Deviation 4.68
Body Weight Group <=40 kg: OPTISON	Change From Baseline in Systolic and Diastolic Blood Pressure	Diastolic Blood Pressure: Change at 10 Minutes Post Last Dose	-2.8 millimeter of mercury (mmHg)	Standard Deviation 5.37
Body Weight Group >40 kg: OPTISON	Change From Baseline in Systolic and Diastolic Blood Pressure	Diastolic Blood Pressure: Change at 60 Minutes Post Last Dose	-1.1 millimeter of mercury (mmHg)	Standard Deviation 9.95
Body Weight Group >40 kg: OPTISON	Change From Baseline in Systolic and Diastolic Blood Pressure	Systolic Blood Pressure: Change at 10 Minutes Post Last Dose	-4.6 millimeter of mercury (mmHg)	Standard Deviation 10.46
Body Weight Group >40 kg: OPTISON	Change From Baseline in Systolic and Diastolic Blood Pressure	Diastolic Blood Pressure: Change at 10 Minutes Post Last Dose	-2.5 millimeter of mercury (mmHg)	Standard Deviation 11.67
Body Weight Group >40 kg: OPTISON	Change From Baseline in Systolic and Diastolic Blood Pressure	Systolic Blood Pressure: Change at 60 Minutes Post Last Dose	-3.8 millimeter of mercury (mmHg)	Standard Deviation 12.01

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.

Time frame: 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

Population: 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.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	2 minutes (1-2 minutes contrast duration)	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	10 minutes (7-10 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	0 minute	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	10 minutes (7-10 minutes contrast duration)	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	2 minutes (1-2 minutes contrast duration)	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	4 minutes (2-4 minutes contrast duration)	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	7 minutes (4-7 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	10 minutes (7-10 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	0 minute	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	10 minutes (7-10 minutes contrast duration)	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	0 minute	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	1 minute (<1 minute contrast duration)	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	2 minutes (1-2 minutes contrast duration)	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	4 minutes (2-4 minutes contrast duration)	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	7 minutes (4-7 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	10 minutes (7-10 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	1 minute (<1 minute contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	4 minutes (2-4 minutes contrast duration)	4 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	7 minutes (4-7 minutes contrast duration)	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	10 minutes (7-10 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	0 minute	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	1 minute (<1 minute contrast duration)	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	2 minutes (1-2 minutes contrast duration)	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	4 minutes (2-4 minutes contrast duration)	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	7 minutes (4-7 minutes contrast duration)	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	1 minute (<1 minute contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	2 minutes (1-2 minutes contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	4 minutes (2-4 minutes contrast duration)	5 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	7 minutes (4-7 minutes contrast duration)	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	0 minute	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	1 minute (<1 minute contrast duration)	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	0 minute	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	1 minute (<1 minute contrast duration)	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	2 minutes (1-2 minutes contrast duration)	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	4 minutes (2-4 minutes contrast duration)	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	7 minutes (4-7 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	10 minutes (7-10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	1 minute (<1 minute contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	2 minutes (1-2 minutes contrast duration)	7 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	10 minutes (7-10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	2 minutes (1-2 minutes contrast duration)	3 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	7 minutes (4-7 minutes contrast duration)	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	4 minutes (2-4 minutes contrast duration)	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	4 minutes (2-4 minutes contrast duration)	14 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	7 minutes (4-7 minutes contrast duration)	4 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	10 minutes (7-10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	4 minutes (2-4 minutes contrast duration)	14 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	1 minute (<1 minute contrast duration)	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	0 minute	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	0 minute	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	4 minutes (2-4 minutes contrast duration)	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	7 minutes (4-7 minutes contrast duration)	5 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	7 minutes (4-7 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	1 minute (<1 minute contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	7 minutes (4-7 minutes contrast duration)	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	2 minutes (1-2 minutes contrast duration)	7 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	10 minutes (7-10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	2 minutes (1-2 minutes contrast duration)	6 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	4 minutes (2-4 minutes contrast duration)	11 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	0 minute	3 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	0 minute	3 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	1 minute (<1 minute contrast duration)	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 1	10 minutes (7-10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	2 minutes (1-2 minutes contrast duration)	5 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 2	1 minute (<1 minute contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	4 minutes (2-4 minutes contrast duration)	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	0 minute	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	7 minutes (4-7 minutes contrast duration)	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 3: OPTISON Dose Level 1	2 minutes (1-2 minutes contrast duration)	7 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	10 minutes (7-10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 2: OPTISON Dose Level 2	1 minute (<1 minute contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 1	None of the above (>10 minutes contrast duration)	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber	Reader 1: OPTISON Dose Level 2	0 minute	2 Participants

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.

Time frame: 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

Population: 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.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 1	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 1	Low	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 1	Medium	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 1	High	4 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 1	Blooming	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 2	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 2	Medium	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 2	High	7 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 1	High	5 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 1	Blooming	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 2	Medium	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 2	Low	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 2	Blooming	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 1	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 1	Low	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 1	Medium	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 2	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 2	Low	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 2	Medium	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 2	High	7 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 2	Blooming	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 1	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 1	Low	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 1	Medium	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 1	High	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 1	Blooming	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 2	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 2	Low	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 2	High	7 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 2	Blooming	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 1	Low	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 1	None	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 1	High	6 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 1	Low	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 1	Blooming	3 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 1	Medium	8 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 2	None	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 1	High	12 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 2	None	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 1	Blooming	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 1	Medium	9 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 2	None	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 2	Low	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 2	High	14 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 2	Medium	8 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 2	Blooming	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 1	Medium	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 1	High	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 2	High	12 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 2	Low	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 2	Low	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 2	Medium	7 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 2	Medium	5 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 2	Blooming	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 1: OPTISON Dose Level 2	High	16 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 1	Blooming	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 1	None	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 1	None	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 3: OPTISON Dose Level 2	Blooming	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity	Reader 2: OPTISON Dose Level 1	Low	1 Participants

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.

Time frame: 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

Population: 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.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: Non-contrast	No confidence	4 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: Non-contrast	Low confidence	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 1	Low confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 1	Moderate confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 1	High confidence	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 2	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 2	High confidence	7 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: Non-contrast	No confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: Non-contrast	Low confidence	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: Non-contrast	High confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 1	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 1	Low confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 1	Moderate confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 2	Low confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 2	High confidence	6 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: Non-contrast	High confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 1	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 1	Moderate confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 2	Moderate confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 2	High confidence	5 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: Non-contrast	Moderate confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: Non-contrast	High confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 1	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 2	Low confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 2	Moderate confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: Non-contrast	Moderate confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 1	High confidence	4 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 2	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 2	Moderate confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: Non-contrast	No confidence	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: Non-contrast	Low confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: Non-contrast	Moderate confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 1	Low confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 1	High confidence	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 2	No confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 2	Low confidence	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 1	No confidence	4 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: Non-contrast	No confidence	11 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 1	Low confidence	5 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: Non-contrast	High confidence	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 1	No confidence	5 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: Non-contrast	Moderate confidence	3 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 1	Low confidence	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 1	Moderate confidence	7 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 1	High confidence	6 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 1	High confidence	6 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 2	Low confidence	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 2	No confidence	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 2	Low confidence	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 2	Moderate confidence	11 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 2	Moderate confidence	8 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 2	High confidence	9 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 2	Moderate confidence	6 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: Non-contrast	No confidence	16 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 1	Moderate confidence	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: Non-contrast	Low confidence	5 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: Non-contrast	Moderate confidence	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 2	High confidence	9 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: Non-contrast	High confidence	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: Non-contrast	Low confidence	11 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 1	No confidence	4 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: OPTISON Dose Level 2	No confidence	7 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 1	Low confidence	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: Non-contrast	Moderate confidence	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 2	No confidence	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 1	High confidence	8 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: Non-contrast	No confidence	17 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 2	High confidence	12 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: Non-contrast	Low confidence	3 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 1: OPTISON Dose Level 1	Moderate confidence	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 3: Non-contrast	High confidence	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography	Reader 2: OPTISON Dose Level 2	Low confidence	1 Participants

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.

Time frame: 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

Population: 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.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: Non-contrast	No confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: Non-contrast	Low confidence	4 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: Non-contrast	Moderate confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: Non-contrast	High confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 1	High confidence	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 2	Low confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: Non-contrast	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: Non-contrast	Moderate confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 1	Moderate confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 2	Low confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: Non-contrast	Moderate confidence	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 1	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 1	Moderate confidence	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 1	High confidence	3 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 2	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 2	Moderate confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 1	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 1	Low confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 1	Moderate confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 2	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 2	Moderate confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 2	High confidence	7 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: Non-contrast	Low confidence	6 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: Non-contrast	High confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 1	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 1	Low confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 1	High confidence	4 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 2	No confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 2	Moderate confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 2	High confidence	6 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: Non-contrast	No confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: Non-contrast	Low confidence	2 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: Non-contrast	High confidence	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 1	Low confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 2	Low confidence	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 2	High confidence	5 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: Non-contrast	High confidence	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: Non-contrast	No confidence	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 2	High confidence	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: Non-contrast	Low confidence	9 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 1	No confidence	3 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 1	Moderate confidence	7 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 1	Low confidence	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 2	No confidence	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 2	Moderate confidence	11 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 2	Low confidence	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 2	High confidence	9 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 1	Moderate confidence	9 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: Non-contrast	No confidence	6 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: Non-contrast	Low confidence	15 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 1	High confidence	8 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: Non-contrast	Moderate confidence	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: Non-contrast	High confidence	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 1	Low confidence	3 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 1	High confidence	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 2	No confidence	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 1	No confidence	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: Non-contrast	No confidence	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: OPTISON Dose Level 2	Moderate confidence	11 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: Non-contrast	High confidence	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 2	Low confidence	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 1	Low confidence	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: Non-contrast	Low confidence	7 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 1	Moderate confidence	7 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 2	Moderate confidence	10 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 1	High confidence	11 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: Non-contrast	Moderate confidence	5 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 2	No confidence	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 2	Low confidence	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 2: OPTISON Dose Level 1	No confidence	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 3: OPTISON Dose Level 2	High confidence	11 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images	Reader 1: Non-contrast	Moderate confidence	4 Participants

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.

Time frame: 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

Population: 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.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 2	Faint	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 1	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 1	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 1	Faint	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 1	Intermediate	1 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 1	Full	5 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 2	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 2	Intermediate	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 2	Full	7 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 1	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 1	Faint	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 1	Intermediate	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 1	Full	6 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 2	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 2	Faint	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 2	Intermediate	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 2	Full	7 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 1	Faint	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 1	Intermediate	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 1	Full	6 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 2	None	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 2	Faint	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 2	Intermediate	0 Participants
Body Weight Group <=40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 2	Full	7 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 2	Intermediate	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 2	None	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 1	Full	18 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 1	None	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 1	Intermediate	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 1	None	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 2	None	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 1	Faint	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 2	Faint	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 1	Intermediate	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 2	Faint	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 1	Full	18 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 1	Full	19 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 2	Faint	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 2	Intermediate	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 2	Intermediate	3 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 2	Full	20 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 1: OPTISON Dose Level 2	Full	19 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 2	Full	20 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 1	None	2 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 2	None	1 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 1	Faint	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 3: OPTISON Dose Level 1	Faint	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling	Reader 2: OPTISON Dose Level 1	Intermediate	2 Participants

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.

Time frame: From first dose (Day 1) of study drug to 60 minutes post last dose on Day 1

Population: The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Body Weight Group <=40 kg: OPTISON	Number of Participants With Clinically Significant Abnormality in Physical Examination Findings	0 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants With Clinically Significant Abnormality in Physical Examination Findings	0 Participants

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.

Time frame: 0- 72 hours

Population: The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Body Weight Group <=40 kg: OPTISON	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	4 Participants
Body Weight Group >40 kg: OPTISON	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	9 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Study to Determine Safety and Dosage of OPTISON in Pediatric Participants

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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)

Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters

Change From Baseline in Heart Rate

Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry

Change From Baseline in Respiratory Rate

Change From Baseline in Systolic and Diastolic Blood Pressure

Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber

Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity

Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography

Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images

Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling

Number of Participants With Clinically Significant Abnormality in Physical Examination Findings

Number of Participants With Treatment-emergent Adverse Events (TEAEs)