| Primary | Responder by Independent Rater's Assessment at Maximum Frown at Week 4 | The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 4 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| | | Title | Denominators | Categories |
|---|
| | |
| | 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 |
|---|
| Null Hypothesis: Response rate of IncobotulinumtoxinA (Xeomin®/Bocouture®) minus the response rate of OnabotulinumtoxinA (Vistabel®) is lower or equal -15% (non-inferiority margin). | | | | | difference of response rates | 0.7 | | | 2-Sided | 95 | -3.2 | 7.1 | | | Difference of response rates = response rate in IncobotulinumtoxinA (Xeomin®/Bocouture®) - response rate in OnabotulinumtoxinA (Vistabel®) | Yes | Non-Inferiority or Equivalence | A two-sided 95% Newcombe confidence interval for proportions (paired data) was applied. The lower bound of the Newcombe-Wilson confidence interval of the difference in response rates between groups was compared to the non-inferiority margin of -15%. |
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| Secondary | Responder by Independent Rater's Assessment at Maximum Frown at Week 12 | The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 12 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Independent Rater's Assessment at Rest at Week 4 | The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 4 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Independent Rater's Assessment at Rest at Week 12 | The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 12 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Investigator's Assessment at Maximum Frown at Week 4 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 4 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Investigator's Assessment at Maximum Frown at Week 12 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 12 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Investigator's Assessment at Rest at Week 4 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 4 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Investigator's Assessment at Rest at Week 12 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 12 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Patient's Assessment at Maximum Frown at Week 4 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 4 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Patient's Assessment at Maximum Frown at Week 12 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 12 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Patient's Assessment at Rest at Week 4 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 4 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Response by Patient's Assessment at Rest at Week 12 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed. | Posted | | Number | | participants | | 12 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Patient's Global Assessment at Week 4 | The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed. | Posted | | Number | | participants | | 4 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |
| Secondary | Responder by Patient's Global Assessment at Week 12 | The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient. | Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed. | Posted | | Number | | participants | | 12 weeks after injection | | | | ID | Title | Description |
|---|
| OG000 | IncobotulinumtoxinA (Xeomin®/Bocouture®) | | | OG001 | OnabotulinumtoxinA (Vistabel®) | |
| |