| Primary | Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12 | Participants who remained in the study and were on BRV treatment for at least 1 year (>=330 days) after their start of BRV were classed as having 12 months of treatment retention. | The Full Analysis Set (FAS) was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this non interventional study (NIS). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 12 (end of Observation Period) | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| | | Title | Denominators | Categories |
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| Secondary | Percentage of Participants Remaining in the Study and on BRV Treatment at Month 3 | Participants who remained in the study and were on BRV treatment for at least 3 months (>=90 days) after first BRV administration were classed as having 3 months of treatment retention. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percentage of Participants Remaining in the Study and on BRV Treatment at Month 6 | Participants who remained in the study and were on BRV treatment for at least 6 months (>=180 days) after first BRV administration were classed as having 6 months of treatment retention. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Mean | Standard Deviation | seizures per 28 days | | From Baseline (Day 1) to Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Mean | Standard Deviation | seizures per 28 days | | From Baseline (Day 1) to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Mean | Standard Deviation | seizures per 28 days | | From Baseline (Day 1) to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment and were classified as study completers or who withdrew early. | Posted | | Mean | Standard Deviation | seizures per 28 days | | From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 | Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Mean | Standard Deviation | percent change | | From Baseline (Day 1) to Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 | Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Mean | Standard Deviation | percent change | | From Baseline (Day 1) to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 | Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Mean | Standard Deviation | percent change | | From Baseline (Day 1) to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period | Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment and were classified as study completers or who withdrew early. | Posted | | Mean | Standard Deviation | percent change | | From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 | Response was defined as a (greater than or equal to [>=] 50%) reduction from Baseline in seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Count of Participants | | Participants | No | Baseline (Day 1) to Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 | Response was defined as a >=50% reduction from Baseline in seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Number | | percentage of participants | | Baseline (Day 1) to Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6 | Response was defined as a >=50% reduction from Baseline in seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Count of Participants | | Participants | No | Baseline (Day 1) to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6 | Response was defined as a >=50% reduction from Baseline in seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Number | | percentage of participants | | Baseline (Day 1) to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |
| Secondary | Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12 | Response was defined as a >=50% reduction from Baseline in seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Count of Participants | | Participants | No | Baseline (Day 1) to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12 | Response was defined as a >=50% reduction from Baseline in seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Number | | percentage of participants | | Baseline (Day 1) to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period | Response was defined as a >=50% reduction from Baseline in seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment and were classified as study completers or who withdrew early. | Posted | | Count of Participants | | Participants | No | Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period | Response was defined as a >=50% reduction from Baseline in seizure frequency. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment and were classified as study completers or who withdrew early. | Posted | | Number | | percentage of participants | | Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 2 [Month 3] = Day 90) were counted as No. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment | Posted | | Count of Participants | | Participants | No | Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 2 [Month 3] = Day 90) were counted as No. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Count of Participants | | Participants | No | Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 3 [Month 6] = Day 180) were counted as No. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Count of Participants | | Participants | No | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
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| Secondary | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 3 [Month 6] = Day 180) were counted as No. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Number | | percentage of participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |
| Secondary | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Count of Participants | | Participants | No | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |
| Secondary | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Number | | percentage of participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |
| Secondary | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 4 [Month 12] = Day 330) were counted as No. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Count of Participants | | Participants | No | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |
| Secondary | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 4 [Month 12] = Day 330) were counted as No. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Number | | percentage of participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |
| Secondary | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Count of Participants | | Participants | No | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |
| Secondary | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment. | Posted | | Number | | percentage of participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |
| Secondary | Time to First Seizure After First Dose of Brivaracetam | Time to first seizure was calculated as: Date of first seizure - date of first BRV administration + 1. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. | Posted | | Median | 95% Confidence Interval | days | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |
| Secondary | Number of Seizure Free Participants at End of Observation Period | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. End of Observation Period (up to Month 12), includes participants who are completers or withdrew early. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. | Posted | | Count of Participants | | Participants | | End of Observation Period (up to Month 12/withdrawal) | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |
| Secondary | Percent of Seizure Free Participants at End of Observation Period | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. End of Observation Period (up to Month 12), includes participants who are completers or withdrew early. | FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. | Posted | | Number | | percentage of participants | | End of Observation Period (up to Month 12/withdrawal) | | | | ID | Title | Description |
|---|
| OG000 | Brivaracetam (FAS) | Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS). |
| |