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Omalizumab (Xolair): Treatment of Adults and Adolescents (12 Years of Age and above) with Chronic Idiopathic Urticaria [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Aug.

Cover of Omalizumab (Xolair)

Omalizumab (Xolair): Treatment of Adults and Adolescents (12 Years of Age and above) with Chronic Idiopathic Urticaria [Internet].

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APPENDIX 4DETAILED OUTCOME DATA

Figure 5. ASTERIA I Study Design

Figure 6. ASTERIA II Study Design

Figure 7. GLACIAL Study Design

Table 16. Concomitant Medications — New Onset During the Treatment Period: ASTERIA I (Modified Intention-to-Treat)

Table 17. Concomitant Medications — New Onset During the Treatment Period: ASTERIA II (Modified Intention-to-Treat)

Table 18. Concomitant Medications — New Onset During the Treatment Period: GLACIAL (Modified Intention-to-Treat)

Table 19. Use of Rescue Medication at Week 12: Modified Intention-to-Treat Population

Figure 8. Mean Change From Baseline in Weekly Itch Severity Score by Study Week — ASTERIA I (Baseline Observation Carried Forward Method): Modified Intention-to-Treat Population

Figure 9. Mean Change From Baseline in Weekly Itch Severity Score by Study Week — ASTERIA II (Baseline Observation Carried Forward Method): Modified Intention-to-Treat Population

Figure 10. Mean Change From Baseline in Weekly Itch Severity Score by Study Week — GLACIAL (Baseline Observation Carried Forward Method): Modified Intention-to-Treat Population

Figure 11. Mean Change From Baseline in Weekly Number of Hives Score by Study Week — ASTERIA I (Baseline Observation Carried Forward Method): Modified Intention-to-Treat Population

Figure 12. Mean Change From Baseline in Weekly Number of Hives Score by Study Week — ASTERIA II (Baseline Observation Carried Forward Method): Modified Intention-to-Treat Population

Figure 13. Mean Change From Baseline in Weekly Number of Hives Score by Study Week — GLACIAL (Baseline Observation Carried Forward Method): Modified Intention-to-Treat Population

Figure 14. Subgroup Analysis of Change From Baseline in Weekly Itch Severity Score at Week 12 (Baseline Observation Carried Forward) — ASTERIA I: 300 mg Versus Placebo

Figure 15. Subgroup Analysis of Change From Baseline in Weekly Itch Severity Score at Week 12 (Baseline Observation Carried Forward) — ASTERIA I: 150 mg Versus Placebo

Figure 16. Subgroup Analysis of Change From Baseline in Weekly Itch Severity Score at Week 12 (Baseline Observation Carried Forward) — ASTERIA II: 300 mg Versus Placebo

Figure 17. Subgroup Analysis of Change From Baseline in Weekly Itch Severity Score at Week 12 (Baseline Observation Carried Forward) — ASTERIA II: 150 mg Versus Placebo

Figure 18. Subgroup Analysis of Change From Baseline in Weekly Itch Severity Score at Week 12 (Baseline Observation Carried Forward) — GLACIAL: 300 mg Versus Placebo

Table 20. Exploratory Efficacy End Points During Treatment Period Up to Week 24: Modified Intention-to-Treat Population

Table 21. Exploratory Efficacy End Points During Follow-Up Period Up to Week 28 — Asteria II: Modified Intention-to-Treat Population

Table 22. Exploratory Efficacy End Points During Follow-Up Period Up to Week 40: Modified Intention-to-Treat Population

Copyright © CADTH 2015.

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: NBK362662

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