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| ID | Type | Description | Link |
|---|---|---|---|
| 309762 | Other Identifier | Company internal |
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The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadobutrol, then Gadopentate dimeglumine | Experimental | Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged |
|
| Gadopentate, dimeglumine then Gadobutrol | Experimental | Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadobutrol (Gadavist, Gadovist, BAY86-4875) | Drug | Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Vessel Segments Visualized With Diagnostic Quality | Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image. | 20-30 seconds after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. | immediately before and 20-30 seconds after injection (precontrast and postcontrast) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu | Sichuan | 610041 | China | |||
Of 87 screened participants, 4 were not randomized (2 due to withdrawal of consent, 1 due to entering another clinical study and 1 was lost to follow-up). Thus, 83 participants were randomized to either the sequence Gadobutrol/Gadopentate dimeglumine (41 participants) or Gadopentate dimeglumine/Gadobutrol (42 participants).
Participants were recruited at specialized study centers if they satisfied the inclusion and exclusion criteria. All had known or suspected stenosis of arterial vessels in different vascular body regions with an indication for contrast-enhanced magnetic resonance angiography for diagnosis and further treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine | Period 1: Gadobutrol 0.2 - 0.3 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Gadopentate dimeglumine (Magnevist, BAY86-4882) | Drug | Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) |
|
| Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. | immediately before and 20-30 seconds after injection (precontrast and postcontrast) |
| Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. | immediately before and 20-30 seconds after injection (precontrast and postcontrast) |
| Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. | immediately before and 20-30 seconds after injection (precontrast and postcontrast) |
| MRA Diagnosis by Investigators | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable. | 20-30 seconds after injection |
| MRA Diagnosis by Blinded Reader 1 | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable. | 20-30 seconds after injection |
| MRA Diagnosis by Blinded Reader 2 | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable. | 20-30 seconds after injection |
| MRA Diagnosis by Blinded Reader 3 | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable. | 20-30 seconds after injection |
| Beijing |
| 100853 |
| China |
| Shanghai | 200025 | China |
| FG001 | Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol | Period 1: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadobutrol 0.2 - 0.3 mmol/kg BW (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine | Period 1: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). |
| BG001 | Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol | Period 1: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number of Vessel Segments Visualized With Diagnostic Quality | Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image. | Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only. | Posted | Mean | Standard Deviation | vessel segments | 20-30 seconds after injection |
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| Secondary | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. | Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. | Posted | Number | Participants | immediately before and 20-30 seconds after injection (precontrast and postcontrast) |
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| Secondary | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. | Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only. | Posted | Number | Participants | immediately before and 20-30 seconds after injection (precontrast and postcontrast) |
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| Secondary | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. | Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only. | Posted | Number | Participants | immediately before and 20-30 seconds after injection (precontrast and postcontrast) |
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| Secondary | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. | Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only. | Posted | Number | Participants | immediately before and 20-30 seconds after injection (precontrast and postcontrast) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MRA Diagnosis by Investigators | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable. | Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. | Posted | Number | Vessels | 20-30 seconds after injection |
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| Secondary | MRA Diagnosis by Blinded Reader 1 | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable. | Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only. | Posted | Number | Vessels | 20-30 seconds after injection |
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| Secondary | MRA Diagnosis by Blinded Reader 2 | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable. | Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only. | Posted | Number | Vessels | 20-30 seconds after injection |
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| Secondary | MRA Diagnosis by Blinded Reader 3 | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable. | Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only. | Posted | Number | Vessels | 20-30 seconds after injection |
|
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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 | Gadobutrol (Gadavist, BAY86-4875) | Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) | 0 | 78 | 7 | 78 | ||
| EG001 | Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) | 0 | 81 | 7 | 81 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA, version 10.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA, version 10.0 | Non-systematic Assessment |
|
PIs shall provide sponsor with an advance copy of any proposed publication or oral presentation at least ninety (90) days prior to the date of the planned submission or presentation. Sponsor shall have sixty (60) days to recommend any changes it reasonably believes are necessary for scientific purposes or to preserve the confidentiality of sponsor's confidential information. PIs agree that the adoption of such recommended changes shall not be unreasonably refused.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C090600 | gadobutrol |
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Adverse Event |
|
| Technical problems |
|
| Male |
|
| Reader 2 |
|
| Reader 3 |
|
| Yes |
| Non-Inferiority or Equivalence |
Estimates for investigators only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions. |
| Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design. | Fieller-type confidence interval | Ratio of means | 0.9540 | 90 | 0.9122 | 0.9965 | For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85. | Yes | Non-Inferiority or Equivalence | Estimates for blinded reader 1 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions. |
| Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design. | Fieller-type confidence interval | Ratio of means | 0.9458 | 90 | 0.8776 | 1.0240 | For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85. | Yes | Non-Inferiority or Equivalence | Estimates for blinded reader 2 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions. |
| Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design. | Fieller-type confidence interval | Ratio of means | 0.8698 | 90 | 0.7800 | 0.9657 | For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85. | Yes | Non-Inferiority or Equivalence | Estimates for blinded reader 3 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions. |
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