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The purpose of this study is to demonstrate the superiority of SonoVue®-enhanced ultrasound versus unenhanced ultrasound for characterization of Focal Liver Lesions using final diagnosis based on histology or combined imaging/clinical data as truth standard.
Unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received SonoVue | Other | Patients with at least 1 target lesion requiring work-up for characterization to undergo
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SonoVue-enhanced ultrasound | Drug | Contrast-enhanced ultrasound (CE-US) examination of the target lesion. Drug: SonoVue® Dose of 2.4 mL bolus injection administered intravenously. Maximum of 2 injections (4.8 mL) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard | Sensitivity of SonoVue-enhanced ultrasound (SonoVue CE-US) versus unenhanced ultrasound (UE-US) for characterization of malignant focal liver lesions (FLLs), using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the Intent-to-Diagnose (ITD) population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard. Truth standard: contrast-enhanced computed tomography (CE CT) and /or contrast-enhanced magnetic resonance imaging (CE-MRI) examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per truth standard) x 100. | 24 hours to 6 months |
| Specificity: Percentage of True Negative Lesions Among All Malignant Lesions Per Truth Standard | Specificity of SonoVue-enhanced versus unenhanced ultrasound for characterization of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per truth standard) x 100. | 24 hours to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy: Percentage of True Positive and True Negative Among All Lesions | The Accuracy of SonoVue-enhanced versus unenhanced ultrasound for characterization of malignant and benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard. True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive and true negative lesions/number of total lesions per truth standard) x 100. |
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Inclusion Criteria:
Exclusion Criteria:
Has an acoustic window insufficient for adequate ultrasound examination of the liver.
Has a FLL that cannot be identified with unenhanced ultrasound.
Has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion.
Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of SonoVue®.
Has previously been enrolled in and completed this study.
Known right to left cardiac shunt, bidirectional or transient.
Has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of SonoVue®).
Has any contraindication to 1 of the planned imaging procedures (ultrasound, CT or MRI), e.g., implants, claustrophobia, inadequate medical conditions etc.
Has received an investigational compound within 30 days before admission into this study.
Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
Is determined by the Investigator that the subject is clinically unsuitable for the study.
Is a pregnant or lactating female. Exclude the possibility of pregnancy by:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Luigia Storto, M.D. | Bracco Diagnostics, Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bracco Diagnostics Inc | Princeton | New Jersey | 08540 | United States |
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A total of 74 patients received SonoVue in the training phase and were included only in safety population. A total of 263 patients received SonoVue in the efficacy phase. The 74 patients, included within the "Not Completed" category below, are the training patients.
Study Initiation Date (first subject enrolled): 30 September 2009; Study completion date (last patient completed study related activities): 29 January 2013. The study was conducted at 14 investigational sites throughout the United States (USA) and 1 site in Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety Population | Interventions included SonoVue administration, unenhanced and SonoVue-enhanced ultrasound and definitive truth standard diagnosis. Any patient who received SonoVue, training or efficacy phase, regardless of availability of ultrasonography or truth standard, is included in the Safety Population. Twelve patients with "No study drug administered" are not included in the Safety Population. From 337 patients in the Safety Population, 74 patients enrolled in the training phase were excluded from efficacy analysis, and the Completed patients include efficacy phase patients who underwent SonoVue-enhanced ultrasound (SonoVue CE-US), unenhanced ultrasound (UE-US),and had definite truth standard diagnosis available. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ITD Population | All patients who received SonoVue and enrolled in the efficacy phase, had a definite final diagnosis from truth standard and unenhanced and SonoVue-enhanced ultrasonography available |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard | Sensitivity of SonoVue-enhanced ultrasound (SonoVue CE-US) versus unenhanced ultrasound (UE-US) for characterization of malignant focal liver lesions (FLLs), using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the Intent-to-Diagnose (ITD) population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard. Truth standard: contrast-enhanced computed tomography (CE CT) and /or contrast-enhanced magnetic resonance imaging (CE-MRI) examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per truth standard) x 100. | Among the 240 ITD participants, only 124 participants (lesions) were malignant based on the truth standard and were included for sensitivity. | Posted | Number | 95% Confidence Interval | Percentage of true positive lesions | 24 hours to 6 months | Malignant lesions | Malignant lesions |
Up to 7 days after contrast media injection
An AE was defined as any untoward medical occurrence in a patient or a clinical trial subject administered a medicinal product and that did not necessarily have to have a causal relationship with the use of the product. Any patient who received SonoVue is in the Safety Population.
Of 349 patients who started the study, 12 had "No study drug administered" and are not included and 337 received SonoVue and are included in the Safety Population.
All AEs were categorized using MedDRA 12.1.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population | Interventions included SonoVue administration, unenhanced and SonoVue-enhanced ultrasound and definitive truth standard diagnosis. Any patient who received SonoVue, training or efficacy phase, regardless of availability of ultrasonography or truth standard, is included in the Safety Population. Twelve patients with "No study drug administered" are not included in the Safety Population. Of 349 patients who started the study, 12 patients had "No study drug administered" and are not included and 337 received SonoVue and are included in the Safety Population. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Luigia Storto, MD Executive Director X-Ray and Ultrasound Medical Affairs | Bracco Diagnostics Inc. | (609) 514-2200 | MariaLuigia.Storto@diag.bracco.com |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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|
| Unenhanced ultrasound | Other | -Unenhanced: Gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion. Drug: None |
|
| 24 hours to 6 months |
| Positive Predictive Value (PPV): Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound | Positive Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per ultrasound) x 100. | 24 hours to 6 months |
| Negative Predictive Value (NPV): Percentage of True Negative Lesions Among All Malignant Lesions Per Ultrasound | Negative Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per ultrasound) x 100. | 24 hours to 6 months |
| Specific Diagnosis of Malignant FLLs | SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of malignant FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100. | 24 hours to 6 months |
| Specific Diagnosis of Benign FLLs | SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100. | 24 hours to 6 months |
| Inter-reader Agreement | Inter-reader agreement of assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. Computation for the percentage agreement within two categories: "3 out of 3 readers agree" and "2 out of 3 readers agree". | 24 hours to 6 months |
| Technically inadequate truth standard |
|
| Indeterminate diagnosis from truth stand |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Offsite Reader 1 - UE-US | Offsite Reader 1 unenhanced (UE) US assessment |
| OG001 | Offsite Reader 1 SonoVue CE-US | Offsite Reader 1 SonoVue CE-US assessment |
| OG002 | Offsite Reader 2 - UE-US | Offsite Reader 2 UE-US assessment |
| OG003 | Offsite Reader 2 SonoVue CE-US | Offsite Reader 2 SonoVue CE-US assessment |
| OG004 | Offsite Reader 3 UE-US | Offsite Reader 3 UE-US assessment |
| OG005 | Offsite Reader 3 SonoVue CE-US | Offsite Reader 3 SonoVue CE-US assessment |
|
|
|
| Primary | Specificity: Percentage of True Negative Lesions Among All Malignant Lesions Per Truth Standard | Specificity of SonoVue-enhanced versus unenhanced ultrasound for characterization of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per truth standard) x 100. | Among the 240 ITD participants, only 116 participants (lesions) were benign based on the truth standard and were included for specificity. | Posted | Number | 95% Confidence Interval | Percentage of true negative lesions | 24 hours to 6 months | Benign lesions | Benign lesions |
|
|
|
|
| Secondary | Accuracy: Percentage of True Positive and True Negative Among All Lesions | The Accuracy of SonoVue-enhanced versus unenhanced ultrasound for characterization of malignant and benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard. True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive and true negative lesions/number of total lesions per truth standard) x 100. | 240 participants in the ITD population | Posted | Number | 95% Confidence Interval | Percent true positive and negative lesio | 24 hours to 6 months | Total lesions | Total lesions |
|
|
|
|
| Secondary | Positive Predictive Value (PPV): Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound | Positive Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per ultrasound) x 100. | Among the 240 ITD participants, the overall number of participants (lesions) assessed as malignant varied based on the evaluation of the UE-US and CE-US made by each off-site Reader. | Posted | Number | 95% Confidence Interval | Percent positive lesions by ultrasound | 24 hours to 6 months | Positive lesions | Positive lesions |
|
|
|
|
| Secondary | Negative Predictive Value (NPV): Percentage of True Negative Lesions Among All Malignant Lesions Per Ultrasound | Negative Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per ultrasound) x 100. | Among the 240 ITD participants, the overall number of participants (lesions) assessed as benign varied based on the evaluation of the UE-US and CE-US made by each off-site Reader. | Posted | Number | 95% Confidence Interval | Percent negative lesions by ultrasound | 24 hours to 6 months | Negative lesions | Negative lesions |
|
|
|
|
| Secondary | Specific Diagnosis of Malignant FLLs | SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of malignant FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100. | Among the 124 ITD participants with malignant lesions based on the truth standard, only 115 participants (lesions) were characterized as either hepatocellular carcinoma (HCC) lesions or metastatic lesions. | Posted | Number | Malignant lesions | 24 hours to 6 months | Malignant lesions to be characterized | Malignant lesions to be characterized |
|
|
|
| Secondary | Specific Diagnosis of Benign FLLs | SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100. | Among the 116 ITD participants with benign lesions based on the truth standard, only 89 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia. | Posted | Number | Benign lesions | 24 hours to 6 months | Benign lesions to be characterized | Benign lesions to be characterized |
|
|
|
| Secondary | Inter-reader Agreement | Inter-reader agreement of assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. Computation for the percentage agreement within two categories: "3 out of 3 readers agree" and "2 out of 3 readers agree". | Posted | Number | Percent of total number of lesions | 24 hours to 6 months |
|
|
|
| 5 |
| 337 |
| 54 |
| 337 |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site coldness | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gallbladder pain | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Parosmia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Delirium tremens | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diaphragmalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
Study results may be presented at scientific symposia or published in a peer-review journal after review by sponsor in accordance with the guidelines set forth in the applicable publication or financial agreement
| D008107 |
| Liver Diseases |
| Benign lesions |
|
| Difference in Specificity (%) |
| 60.3 |
| 2-Sided |
| 95 |
| 50.5 |
| 70.2 |
| Superiority or Other |
| McNemar | <.0001 | Difference in Specificity (%) | 29.3 | 2-Sided | 95 | 19.7 | 38.9 | Superiority or Other |
| Total lesions |
|
| Difference in Accuracy (%) |
| 39.2 |
| 2-Sided |
| 95 |
| 31.3 |
| 47.1 |
| Superiority or Other |
| McNemar | 0.3173 | Difference in Accuracy (%) | 4.2 | 2-Sided | 95 | -4.0 | 12.3 | Superiority or Other |
| Positive lesions |
|
| Superiority or Other |
| Wald Test | 0.0004 | Superiority or Other |
| Negative lesions |
|
| Superiority or Other |
| Wald Test | 0.7610 | Superiority or Other |
| Malignant lesions to be characterized |
|
| # HCC(Malignant) Correctly Characterized |
|
| # of Metastasis by Truth Standard |
|
| # Metastasis Correctly Characterized |
|
| Benign lesions to be characterized |
|
| # Hemangioma Correctly Characterized |
|
| # of Focal nodular hyperplasia by Truth Standard |
|
| #Focal nodular hyperplasia Correctly Characterized |
|