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Original Research

Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data

, , , , , , , & show all
Pages 1599-1612 | Published online: 11 Aug 2015

Figures & data

Table 1 Details of studies included in the pooled analysis

Table 2 Duration of exposure to study drug after randomization (COPD core S-db)

Table 3 Characteristics of pooled clinical trial study population (COPD core S-db)

Table 4 Incidence of most common AEs (per 100 PTYs) in clinical studies sorted by primary system organ class and preferred term (> 10 events/100 PTYs for GLY) (COPD core S-db)

Table 5 Incidence of AEs most commonly associated with LAMAs, classified according to primary system organ class and preferred term (COPD core S-db)

Table 6 Adjudicated deaths, and SAEs (>0.2 events/100 PTYs for GLY) (COPD core S-db)

Table 7 Incidence of CCV-related AEs and FAEs (defined by SMQ) adjusted for exposure with risk ratio and 95% CI (COPD core S-db)

Table 8 Incidence of cerebrovascular and cardiovascular AEs (defined by SMQ) during long-term (≥ 1 year) period and adjusted for exposure with risk ratio and 95% CI (COPD long-term S-db)

Table 9 Summary of serious and nonserious adverse reactions during PMs sorted by primary system organ class and preferred term

Table 10 Statistical scores for AEs of clinical interest during the PMS phase

Table S1 Number of patients with atrial fibrillation and flutter (adjudicated) adjusted for exposure (COPD core S-db)

Table S2 Number of patients with atrial fibrillation and flutter (adjudicated) adjusted for exposure for long-term safety assessment (COPD long-term S-db)

Table S3 Incidence of CCV-related AEs (per 100 patient years) in clinical studies sorted by primary system organ class and preferred term (>10 events for GLY) (COPD core S-db)

Table S4 Incidence of angioedema (defined by SMQ)-narrow AE episodes adjusted for exposure by primary system organ class and preferred term with RR and 95% CI (COPD core S-db)