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This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance.
This crossover study aims at a comparison between 0.1 mmol/kg MultiHance and 0.1 mmol/kg Dotarem, between 0.05 MultiHance and 0.1 mmol/kg Dotarem in terms of diagnostic preference at CE-MRI in brain tumor patients to show superiority of MultiHance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MultiHance 0.1 then Dotarem 0.1 mmol/kg | Experimental | MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg |
|
| MultiHance 0.05 then Dotarem 0.1 mmol/kg | Experimental | MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg |
|
| Dotarem 0.1 then MultiHance 0.1 mmol/kg | Active Comparator | Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg |
|
| Dotarem 0.1 then MultiHance 0.05 mmol/kg | Active Comparator | Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MultiHance 0.1 mmol/kg | Drug | MultiHance administered at 0.1 mmol/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Diagnostic Preference Between the Two Exams | Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints. | Comparison of image sets obtained within 2 to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Border Delineation | Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianpaolo Pirovano, MD | Bracco Diagnostics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samaritan Health Services | Corvallis | Oregon | 97330 | United States |
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179 patients were enrolled and signed informed consent. Each enrolled patient was randomized and 177 were dosed with at least one contrast agent.
A total of 179 patients were recruited from February 2014 through February 2015 at 14 clinical trial sites. Off-site assessment of the images was performed between 19 February - 17 March 2015 by 3 board-certified neuroradiologists blinded as to which contrast agent was used, patient clinical information, and the results of other imaging studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg | Patients randomized to receive MultiHance 0.1 mmol/kg first |
| FG001 | Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg | Patients randomized to receive Dotarem 0.1 mmol/kg first |
| FG002 | MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg | Patients randomized to receive MultiHance 0.05 mmol/kg first |
| FG003 | Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg | Patients randomized to receive Dotarem 0.1 mmol/kg first |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Injection |
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| Washout (no Second Injection/MRI) |
| |||||||||||||
| Second Injection |
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| ID | Title | Description |
|---|---|---|
| BG000 | MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg | Patients randomized to receive MultiHance 0.1 mmol/kg first |
| BG001 | Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg | Patients randomized to receive Dotarem 0.1 mmol/kg first |
| 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 | Global Diagnostic Preference Between the Two Exams | Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints. | Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations | Posted | Number | participant exams | Comparison of image sets obtained within 2 to 14 days |
|
Up to 24 hours after contrast media injection
All adverse events collected were categorized using MedDRA 17.1 and tabulated
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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 | Study Arm 1 / MultiHance 0.1 mmol/kg | Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with MultiHance 0.1 mmol/kg. 31 (MH as 1st injection) + 34 (MH as 2nd injection) = 65 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gianpaolo Pirovano, MD | Bracco Diagnostics, Inc. | 609-514-2226 | gianpaolo.pirovano@diag.bracco.com |
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| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C064572 | gadobenic acid |
| C072417 | gadoterate meglumine |
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| Dotarem | Drug | Dotarem administered at 0.1 mmol/kg |
|
|
| MultiHance 0.05 mmol/kg | Drug | MultiHance administered at 0.05 mmol/kg |
|
| Comparison of image sets obtained within 2 to 14 days |
| Lesion Internal Morphology | Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints. | Comparison of image sets obtained within 2 to 14 days |
| Extent of Disease | Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints. | Comparison of image sets obtained within 2 to 14 days |
| Lesion Contrast Enhancement | Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints. | Comparison of image sets obtained within 2 to 14 days |
| Lesion to Background Ratio on Post T1-weighed Spin Echo Images | The Unit of Measure is lesion-to-background ratio based on lesions assessed. For each lesion, Lesion-to-background ratio (LBR) = SI of lesion/SI of brain. Firstly, LBR of each lesion was assessed for each contrast agent postdose image separately, then the difference in LBR between MultiHance and Dotarem was calculated. The number presented in the result table below is "the mean difference in LBR postdose (MultiHance - Dotarem)" | 5-10 minutes Postdose |
| Lesion-brain Contrast-to-noise Ratio | The Unit of Measure is contrast-to-noise ratio based on lesions assessed. For each lesion, Lesion-brain Contrast-to-noise Ratio (CNR) = [(SI of lesion - SI of brain)/SD for SI of noise] on Postdose Images of each lesion was calculated for each contrast agent image separately, then the difference in CNR between MultiHance and Dotarem was calculated. The number presented in the result table below is "the mean difference in CNR (MultiHance - Dotarem)" | 5-10 minutes Postdose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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|
| BG002 | MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg | Patients randomized to receive MultiHance 0.05 mmol/kg first |
| BG003 | Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg | Patients randomized to receive Dotarem 0.1 mmol/kg first |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
| OG001 | MultiHance 0.1 mmol/kg Arm (Reader 2) | MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg |
| OG002 | MultiHance 0.1 mmol/kg Arm (Reader 3) | MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg |
| OG003 | MultiHance 0.05 mmol/kg Arm (Reader 1) | MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg |
| OG004 | MultiHance 0.05 mmol/kg Arm (Reader 2) | MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg |
| OG005 | MultiHance 0.05 mmol/kg Arm (Reader 3) | MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg |
|
|
|
| Secondary | Lesion Border Delineation | Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints. | Posted | Number | participant exams | Comparison of image sets obtained within 2 to 14 days |
|
|
|
|
| Secondary | Lesion Internal Morphology | Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints. | Posted | Number | participant exams | Comparison of image sets obtained within 2 to 14 days |
|
|
|
|
| Secondary | Extent of Disease | Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints. | Posted | Number | participant exams | Comparison of image sets obtained within 2 to 14 days |
|
|
|
|
| Secondary | Lesion Contrast Enhancement | Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints. | Posted | Number | Participant Exams | Comparison of image sets obtained within 2 to 14 days |
|
|
|
|
| Secondary | Lesion to Background Ratio on Post T1-weighed Spin Echo Images | The Unit of Measure is lesion-to-background ratio based on lesions assessed. For each lesion, Lesion-to-background ratio (LBR) = SI of lesion/SI of brain. Firstly, LBR of each lesion was assessed for each contrast agent postdose image separately, then the difference in LBR between MultiHance and Dotarem was calculated. The number presented in the result table below is "the mean difference in LBR postdose (MultiHance - Dotarem)" | Posted | Mean | Standard Deviation | ratio based on lesions assessed | 5-10 minutes Postdose | Lesions | Lesions |
|
|
|
|
| Secondary | Lesion-brain Contrast-to-noise Ratio | The Unit of Measure is contrast-to-noise ratio based on lesions assessed. For each lesion, Lesion-brain Contrast-to-noise Ratio (CNR) = [(SI of lesion - SI of brain)/SD for SI of noise] on Postdose Images of each lesion was calculated for each contrast agent image separately, then the difference in CNR between MultiHance and Dotarem was calculated. The number presented in the result table below is "the mean difference in CNR (MultiHance - Dotarem)" | Posted | Mean | Standard Deviation | ratio based on lesions assessed | 5-10 minutes Postdose | Lesions | Lesions |
|
|
|
|
| 0 |
| 65 |
| 1 |
| 65 |
| EG001 | Study Arm 1 / Dotarem 0.1 mmol/kg | Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg. 39 (Dotarem as 1st injection) + 31 (Dotarem as 2nd injection) =70 | 0 | 70 | 2 | 70 |
| EG002 | Study Arm 2/ MultiHance 0.05 mmol/kg | Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with MultiHance 0.05 mmol/kg. 53 (MH as 1st injection) + 51 (MH as 2nd injection) = 104 | 0 | 104 | 3 | 104 |
| EG003 | Study Arm 2 / Dotarem 0.1 mmol/kg | Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg. 54 (Dotarem as 1st injection) + 51 (Dotarem as 2nd injection) =105 | 0 | 105 | 7 | 105 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Injection site swelling | General disorders | Systematic Assessment |
|
| Injection site pruritus | General disorders | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 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
| Contrast Agents Equal |
|
| Dotarem Preferred |
|
This is a secondary analysis. Null hypotheses: A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus post-dose paired global assessment. |
| Wilcoxon signed-rank test |
| 0.8238 |
The priori threshold for statistical significance was 0.05. |
| No |
| Superiority or Other |
| This is a secondary analysis. Null hypotheses: A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed rank test | <0.0001 | The priori threshold for statistical significance was 0.05. | No | Superiority or Other |
| This is a secondary analysis. Null hypotheses: A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed rank test | 0.4597 | The priori threshold for statistical significance was 0.05. | No | Superiority or Other |
| This is a secondary analysis. Null hypotheses: A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed rank test | <0.0001 | The priori threshold for statistical significance was 0.05. | No | Superiority or Other |
| This is a secondary analysis. Null hypotheses: A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed rank test | 0.8145 | The priori threshold for statistical significance was 0.05. | No | Superiority or Other |
| No Difference Between MultiHance and Dotarem |
|
| Dotarem better |
|
| Wilcoxon signed-rank test |
| 1.0000 |
| No |
| Superiority or Other |
| Null hypotheses: A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | 0.0001 | No | Superiority or Other |
| Null hypotheses: A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | 1.0000 | No | Superiority or Other |
| Null hypotheses: A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | <0.0001 | No | Superiority or Other |
| Null hypotheses: A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | 0.5811 | No | Superiority or Other |
| No Difference between MultiHance and Dotarem |
|
| Dotarem Better |
|
| Wilcoxon signed-rank test |
| 1.0000 |
| No |
| Superiority or Other |
| Null hypotheses: A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | <0.0001 | No | Superiority or Other |
| Null hypotheses: A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | 1.0000 | No | Superiority or Other |
| Null hypotheses: A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | 0.0023 | No | Superiority or Other |
| Null hypotheses: A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | 1.0000 | No | Superiority or Other |
| No Difference between MultiHance and Dotarem |
|
| Dotarem Better |
|
| Wilcoxon signed-rank test |
| 1.0000 |
| No |
| Superiority or Other |
| Null hypotheses: A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | <0.0001 | No | Superiority or Other |
| Null hypotheses: A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | 0.7503 | No | Superiority or Other |
| Null hypotheses: A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | <0.0001 | No | Superiority or Other |
| Null hypotheses: A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.05 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment. | Wilcoxon signed-rank test | 0.5983 | No | Superiority or Other |
| Lesions |
|
Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect
| 0.6898 |
| No |
| Superiority or Other |
| Mixed Models Analysis | Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect. | <0.0001 | No | Superiority or Other |
| Mixed Models Analysis | Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect | 0.1156 | No | Superiority or Other |
| Mixed Models Analysis | <0.0001 | No | Superiority or Other |
| Mixed Models Analysis | 0.7726 | No | Superiority or Other |
| Lesions |
|
Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.
| <0.0001 |
| No |
| Superiority or Other |
| Mixed Models Analysis | Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect. | <0.0001 | No | Superiority or Other |
| Mixed Models Analysis | Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect. | <0.0001 | No | Superiority or Other |
| Mixed Models Analysis | Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect. | <0.0001 | No | Superiority or Other |
| Mixed Models Analysis | Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect. | 0.0003 | No | Superiority or Other |