| Primary | Number of Lesions Detected by Blinded Readers (BR) and Investigator | Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Mean | Standard Deviation | lesions | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw | Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw | | OG001 | Gadobutrol 0.2 mmol/kg bw | Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min | | OG002 | Gadoteridol (ProHance) 0.2mmol/kg bw | Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min |
| | | Title | Denominators | Categories |
|---|
| averaged blinded reader | | | Title | Measurements |
|---|
| - OG0006.28± 8.31
- OG0016.92± 8.69
- OG0026.87± 8.65
|
| | investigator |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Mean Difference (Final Values) | -0.58 | | | | 95 | -0.87 | -0.29 | | | Averaged blinded reader (primary analysis) | | Non-Inferiority or Equivalence | non-inferiority margin = -1 | | | |
|
| Secondary | Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader | Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Mean | Standard Deviation | scores on a scale | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw | Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw | | OG001 | Gadobutrol 0.2 mmol/kg bw | Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min | | OG002 | Gadoteridol (ProHance) 0.2mmol/kg bw | Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min |
| |
| Secondary | Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator | Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Mean | Standard Deviation | scores on a scale | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw | Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw | | OG001 | Gadobutrol 0.2 mmol/kg bw | Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min | | OG002 | Gadoteridol (ProHance) 0.2mmol/kg bw | Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min |
| |
| Secondary | Score of Visibility Assessment - Border Delineation by Blinded Reader | Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Mean | Standard Deviation | scores on a scale | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw | Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw | | OG001 | Gadobutrol 0.2 mmol/kg bw | Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min | | OG002 | Gadoteridol (ProHance) 0.2mmol/kg bw | Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min |
| |
| Secondary | Score of Visibility Assessment - Border Delineation by Investigator | Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Mean | Standard Deviation | scores on a scale | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw | Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw | | OG001 | Gadobutrol 0.2 mmol/kg bw | Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min | | OG002 | Gadoteridol (ProHance) 0.2mmol/kg bw | Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min |
| |
| Secondary | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | Treatment planning confidence evaluated separately for each image set (gadobutrol [Gado-] 0.1 mmol/kg bw and gadoteridol [Pro-] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Number | | participants | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) |
| |
| Secondary | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Number | | participants | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) |
| |
| Secondary | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Number | | participants | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) |
| |
| Secondary | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Number | | participants | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) |
| |
| Secondary | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE | Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as "confident in treatment planning" with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure | Posted | | Number | | participants | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) | | OG001 | Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) |
| |
| Secondary | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator | Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as "confident in treatment planning" with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure | Posted | | Number | | participants | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) | | OG001 | Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) |
| |
| Secondary | Number of Participants With Reasons for Performance in SRS Planning by TPE | Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as "confident in treatment planning" with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure | Posted | | Number | | participants | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) | | OG001 | Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) |
| |
| Secondary | Number of Participants With Reasons for Performance in SRS Planning by Investigator | Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as "confident in treatment planning" with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure | Posted | | Number | | participants | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) | | OG001 | Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw | Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) |
| |
| Secondary | Lesion Size Evaluated by Independent Radiologist | Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Mean | Standard Deviation | mm | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw | Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw | | OG001 | Gadobutrol 0.2 mmol/kg bw | Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min | | OG002 | Gadoteridol (ProHance) 0.2mmol/kg bw | Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min |
| |
| Secondary | Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist | CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions) | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Mean | Standard Deviation | CNR | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw | Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw | | OG001 | Gadobutrol 0.2 mmol/kg bw | Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min | | OG002 | Gadoteridol (ProHance) 0.2mmol/kg bw | Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min |
| |
| Secondary | Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions | ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients. | Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure. | Posted | | Number | | ICC | | one day | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg bw | Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw | | OG001 | Gadobutrol 0.2 mmol/kg bw | Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min | | OG002 | Gadoteridol (ProHance) 0.2mmol/kg bw | Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min |
| |