The Journal of Allergy and Clinical Immunology: In Practice

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The Journal of Allergy and Clinical Immunology: In Practice Safety Review of 5-Grass Pollen Tablet from Pooled Data of Clinical Trials Thomas B. Casale, MD, Linda S. Cox, MD, Ulrich Wahn, MD, David B.K. Golden, MD, Brigitte Bons, MD, Alain Didier, MD The Journal of Allergy and Clinical Immunology: In Practice DOI: 10.1016/j.jaip.2017.04.020 Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Figure 1 Subject disposition. Across the development program, subjects were randomized to receive once daily either placebo or active treatment (ie, 100IR, 300IR, or 500IR 5-grass pollen extract sublingual tablet). Reasons for discontinuations were monitored. The Journal of Allergy and Clinical Immunology: In Practice DOI: (10.1016/j.jaip.2017.04.020) Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Figure 2 Incidence of most commonly reported treatment-related AEs by time to onset in adults treated with 300IR 5-grass pollen tablet (A) and children and adolescents treated with 300IR 5-grass pollen tablet (B). The y-axis refers to the percentage of subjects with first occurrence of events. The Journal of Allergy and Clinical Immunology: In Practice DOI: (10.1016/j.jaip.2017.04.020) Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Figure 3 Incidence of most common treatment-related AEs reported over years by time to onset in subjects included in the Long-term study. The y-axis refers to the percentage of subjects with first occurrence of events. 4M, 4-Month preseasonal treatment regimen; 2M, 2-month preseasonal treatment regimen. The Journal of Allergy and Clinical Immunology: In Practice DOI: (10.1016/j.jaip.2017.04.020) Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Figure 4 Percentages of adults reporting treatment-related AEs according to the treatment-initiation scheme. Overall TEAEs during the first 3 days of administration (A). Most frequent TEAEs during the first 3 days with the escalation phase (B) or with direct administration (C). The Journal of Allergy and Clinical Immunology: In Practice DOI: (10.1016/j.jaip.2017.04.020) Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions