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Table 4 Summary of treatment-emergent adverse events

From: Dose selection for glycopyrrolate/eFlow® phase III clinical studies: results from GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) phase II dose-finding studies

  GOLDEN 2 GOLDEN 6
Placebo Glycopyrrolate Placebo Glycopyrrolate Aclidinium
(n = 57) 12.5 μg BID
(n = 55)
25 μg BID
(n = 54)
50 μg BID
(n = 57)
100 μg BID
(n = 59)
(n = 92) 3 μg BID
(n = 91)
6.25 μg BID
(n = 92)
12.5 μg BID
(n = 90)
50 μg BID
(n = 92)
400 μg BID
(n = 94)
Any TEAE, n (%) 15 (26.3) 19 (34.5) 18 (33.3) 18 (31.6) 17 (28.8) 11 (12.0) 22 (24.2) 23 (25.0) 24 (26.7) 14 (15.2) 24 (25.5)
Potentially related TEAEa, n (%) 0 5 (9.1) 2 (3.7) 2 (3.5) 4 (6.8) 4 (4.3) 5 (5.5) 5 (5.4) 9 (10.0) 7 (7.6) 11 (11.7)
Serious TEAE, n (%) 2 (3.5) 2 (3.6) 2 (3.7) 1 (1.8) 3 (5.1) 1 (1.1) 0 2 (2.2) 1 (1.1) 0 3 (3.2)
Discontinuations due to TEAE, n (%) 2 (3.5) 3 (5.5) 4 (7.4) 3 (5.3) 1 (1.7) 1 (1.1) 0 0 1 (1.1) 0 2 (2.1)
  1. BID twice daily, TEAE treatment-emergent adverse event
  2. aConsidered by the Investigator to have a definite, probable, or possible relationship to study drug