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The purpose of this study is to demonstrate the Sensitivity and Specificity of SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant FLLs using final diagnosis based on histology or combined imaging (CE-CT and/or CE MRI)/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 one target lesions requiring work-up for characterization to undergo
2.4 mL of sulfur hexafluoride microbubbles (SonoVue®) will be administered as a bolus injection in a peripheral vein. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SonoVue® | Drug | SonoVue (2.4 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 subject, since each subject had a single lesion 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 truth standard) x 100 | 24 hours to 6 months |
| Specificity: Percentage of True Negative Lesions Among All Benign 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 truth standard. Among the 259 ITD participants, only 140 participants (lesions) were benign based on 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 | 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 truth standard. True negative: subject with a target lesion characterized as benign by both ultrasonography and 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:
Incidentally detected, In subjects with chronic hepatitis or liver cirrhosis, In subjects with known history of malignancy.
Exclusion Criteria:
testing on site at the institution serum βHCG within 24 hours prior to the start of SonoVue® administration, surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses.
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Spinazzi, M.D. | Bracco Diagnostics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bracco Diagnostics Inc. | Princeton | New Jersey | 08540 | United States |
A total of 67 patients received SonoVue in the training phase and were included only in safety population. A total of 259 patients received SonoVue in the efficacy phase. The 67 patients, included within the "Not Completed" category below, are the training patients.
Study Initiation Date (first subject enrolled): 15 June 2010; Study completion date (last patient completed study related activities): 18 February 2013. The study was conducted at 18 investigational sites; 11 sites throughout the United States (USA), 5 sites in Europe, and 2 sites in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety Population | Interventions included SonoVue administration, unenhanced (UE-US) and SonoVue-enhanced ultrasound (CE-US) and definitive truth standard diagnosis. Any patient who received SonoVue is included in the Safety Population. Thirteen patients who started had "No study drug administered" and are not included in the Safety Population. Among patients in the Safety Population, 67 training phase patients were excluded from efficacy analysis. Completed patients included efficacy phase patients who underwent unenhanced and SonoVue-enhanced ultrasound 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 were enrolled in the efficacy phase, received SonoVue, 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 subject, since each subject had a single lesion 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 truth standard) x 100 | Among 259 ITD subjects, 119 were malignant by 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 |
|
Adverse events were monitored from the time of signing the Informed Consent Form through 7 days after SonoVue administration.
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 353 patients who started the study, 13 had "No study drug administered" and are not included and 340 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | 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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| ID | Term |
|---|---|
| C420843 | contrast agent BR1 |
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| 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 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 Benign 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 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. Among the 140 ITD participants with benign lesions based on the truth standard, only 91 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia. 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 | Kappa statistic based on assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately and 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 |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Offsite Reader 1 UE-US | Offsite Reader 1 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 Benign 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 truth standard. Among the 259 ITD participants, only 140 participants (lesions) were benign based on 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 259 ITD participants, only 140 participants (lesions) were benign based on the truth standard and were were included for specificty. | Posted | Number | 95% Confidence Interval | Percentage of true benign lesions | 24 hours to 6 months | Benign lesions | Benign lesions |
|
|
|
|
| Secondary | Accuracy: Percentage of True Positive and True Negative Among All Lesions | 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 truth standard. True negative: subject with a target lesion characterized as benign by both ultrasonography and 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. | 259 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 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 259 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 Benign 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 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 259 ITD participants, the 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 119 ITD participants with malignant lesions based on the truth standard, only 94 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. Among the 140 ITD participants with benign lesions based on the truth standard, only 91 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia. 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 140 ITD participants with benign lesions based on the truth standard, only 91 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 | Kappa statistic based on assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately and computation for the percentage agreement within two categories: "3 out of 3 readers agree" and "2 out of 3 readers agree". | Posted | Number | Percentage of agreement | 24 hours to 6 months |
|
|
|
| 4 |
| 340 |
| 45 |
| 340 |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic hemorrhage | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site irritation | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Basophil count increased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Parosmia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Renal pain | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Flushing | 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 (%) |
| 28.6 |
| 2-Sided |
| 95 |
| 19.7 |
| 37.5 |
| Superiority or Other |
| McNemar | <.0001 | Difference in Specificity (%) | 50.7 | 2-Sided | 95 | 42.0 | 59.5 | Superiority or Other |
| Total lesions |
|
| Difference in Accuracy (%) |
| 34.0 |
| 2-Sided |
| 95 |
| 27.3 |
| 40.7 |
| Superiority or Other |
| McNemar | <.0001 | Difference in Accuracy (%) | 75.6 | 2-Sided | 95 | 67.9 | 83.3 | Superiority or Other |
| Positive lesions |
|
| Superiority or Other |
| Wald Test | <.0001 | Superiority or Other |
| Negative lesions |
|
| Superiority or Other |
| Wald Test | <.0001 | 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 |
|