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Brivaracetam (Brivlera) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2017 Feb.

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Brivaracetam (Brivlera) [Internet].

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APPENDIX 4DETAILED OUTCOME DATA

Table 14. Seizure Freedom in All Seizures (Type 1, 2, and 3) Over Treatment Period (Intention-to-Treat Population).

Table 14

Seizure Freedom in All Seizures (Type 1, 2, and 3) Over Treatment Period (Intention-to-Treat Population).

Table 15Changea From Baseline to End of Treatment Period for QOLIE-31-P Total Score, Sub-scale Scores and Health Status Item (Intention-to-Treat Population)

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QOLIE-31-P = Patient-Weighted Quality of Life in Epilepsy Inventory-31.

a

Descriptive statistics only.

Note: Scores range from 0 to 100, with a positive change indicating improvement in functioning/health status. Only patients who are not mentally impaired were to complete the QOLIE-31-P. Only patients having values at baseline at the considered visit are included.

Source: Study 1252 Clinical Study Report,14 Study 1253 Clinical Study Report,15 Study 1254 Clinical Study Report,16 and Study 1358 Clinical Study Report.17

Table 16Change From Baseline in EQ-5D Visual Analogue Scale for Last Value in Treatment Perioda (Intention-to-Treat Population)

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EQ-5D = EuroQol 5-Dimensions Questionnaire; POS = partial-onset seizure; VAS = visual analogue scale.

a

For Study 1254, the treatment period is (dose-finding plus maintenance periods) and results are presented for the POS population.

b

EQ-5D was an exploratory variable and only descriptive statistics for the VAS were reported.

Source: Study 1252 Clinical Study Report,14 Study 1253 Clinical Study Report,15 and Study 1254 Clinical Study Report.16

Table 17. Partial (Type 1) Seizure Frequency Per Week (Intention-to-Treat Population).

Table 17

Partial (Type 1) Seizure Frequency Per Week (Intention-to-Treat Population).

Table 18. Partial (Type 1) Seizure Frequency Per 28 Days in Study 1358 (Intention-to-Treat Population).

Table 18

Partial (Type 1) Seizure Frequency Per 28 Days in Study 1358 (Intention-to-Treat Population).

Table 19. Fifty Per cent (50%) Responder Rate in Partial (Type 1) Seizure Frequency From Baseline to End of Treatment (Intention-to-Treat Population).

Table 19

Fifty Per cent (50%) Responder Rate in Partial (Type 1) Seizure Frequency From Baseline to End of Treatment (Intention-to-Treat Population).

Table 20. Per Cent Reduction in Partial (Type 1) Seizure Frequency Over the Treatment Period (Intention-to-Treat Population).

Table 20

Per Cent Reduction in Partial (Type 1) Seizure Frequency Over the Treatment Period (Intention-to-Treat Population).

Table 21. Per Cent Reduction in Partial (Type 1) Seizure Frequency by Concomitant Levetiracetam Use (Intention-to-Treat Population).

Table 21

Per Cent Reduction in Partial (Type 1) Seizure Frequency by Concomitant Levetiracetam Use (Intention-to-Treat Population).

Table 22. Categorized Response in Partial (Type 1) Seizure Frequency Over the Treatment Period (Intention-to-Treat Population).

Table 22

Categorized Response in Partial (Type 1) Seizure Frequency Over the Treatment Period (Intention-to-Treat Population).

Table 23Changea From Baseline to End of Treatment Period in HADS Sub-scale Scores (Intention-to-Treat Population)

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HADS = Hospital Anxiety and Depression Scale; ITT = intention-to-treat.

a

Descriptive statistics only.

Note: Anxiety and depression scores range from 0 to 21, with a positive change indicating higher anxiety or depression. Only patients who were not mentally impaired completed the HADS.

Source: Study 1252 Clinical Study Report,14 Study 1253 Clinical Study Report,15 Study 1254 Clinical Study Report,16 and Study 1358 Clinical Study Report.17

Table 24Distribution of Patients by Patient Global Evaluation Scale at Last Visit or Early Discontinuation (Intention-to-Treat Population)

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BRV = brivaracetam; PL = placebo.

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Source: Study 1252 Clinical Study Report,14 Study 1253 Clinical Study Report,15 Study 1254 Clinical Study Report,16 and Study 1358 Clinical Study Report.17

Table 25Distribution of Patients by Investigator Global Evaluation Scale at Last Visit or Early Discontinuation (Intention-to-Treat Population)

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BRV = brivaracetam; PL = placebo; vs. = versus.

a

Evaluable patients are patients who completed the Global Evaluation Scale at last treatment period (visit 7 or early discontinuation visit).

b

Treatment comparisons vs. PL were conducted based on a Cochran-Mantel-Haenszel test for the comparison of row mean scores, and both BRV 100 mg and BRV 200 mg vs. PL were P < 0.001.

c

Treatment comparisons vs. PL were based on a stratified Wilcoxon test.

Source: Study 1252 Clinical Study Report,14 Study 1253 Clinical Study Report,15 Study 1254 Clinical Study Report,16 and Study 1358 Clinical Study Report.17

Table 26. Treatment Compliance Over Treatment Period (Intention-to-Treat Population).

Table 26

Treatment Compliance Over Treatment Period (Intention-to-Treat Population).

Table 27Summary of Concomitant Health Care Resource Utilization by Analysis Perioda (Intention-to-Treat Population)

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ITT = intention to treat; POS = partial-onset seizure.

a

For Study 1254, the treatment period is treatment plus maintenance periods, and results are presented for the ITT POS population. For Study 1358, results are reported in the safety population.

Note: Cost parameters were an exploratory variable and only descriptive statistics were reported in the included trials (i.e., n, %).

Source: Study 1252 Clinical Study Report,14 Study 1253 Clinical Study Report,15 Study 1254 Clinical Study Report,16 and Study 1358 Clinical Study Report.17

Copyright © CADTH 2017.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK447919
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