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Table 4 Treatment-emergent adverse events and serious adverse events during the study period (safety set)

From: Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial

 

LABA + ICS n = 269

IND/GLY n = 816

LABA or LAMAa n = 269

IND/GLYa n = 814

Any adverse event

56 (20.8%)

235 (28.8%)

58 (21.6%)

221 (27.2%)

Any serious adverse event

6 (2.2%)

22 (2.7%)

10 (3.7%)

34 (4.2%)

Any suspected drug-related adverse event

2 (0.7%)

52 (6.4%)

2 (0.7%)

34 (4.2%)

Any suspected drug-related serious adverse event

1 (0.4%)

1 (0.1%)

0 (0.0%)

0 (0.0%)

Any adverse event leading to treatment withdrawal

2 (0.7%)

22 (2.7%)

3 (1.1%)

26 (3.2%)

Any adverse event with a fatal outcome (death)

0 (0.0%)

0 (0.0%)

2 (0.7%)

2 (0.3%)

  1. aPatients had an mMRC score ≥ 2
  2. Data are presented as number of incidences (%)
  3. IND/GLY, indacaterol/glycopyrronium; ITT, intention-to-treat; LABA + ICS, long-acting β2-agonist + inhaled corticosteroid; LAMA, long-acting muscarinic antagonist; mMRC, modified Medical Research Council
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Respiratory Research

ISSN: 1465-993X

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