Table 4

Summary of AEs and MACE by treatment (on treatment analysis*)

VariableTiotropium Respimat
2.5 μg (n=914)
Tiotropium Respimat
5 μg (n=917)
Tiotropium HandiHaler
18 μg (n=951)
Any AE, n (%)711 (77.8)721 (78.6)737 (77.5)
Drug-related AEs, n (%)73 (8.0)66 (7.2)75 (7.9)
 Respiratory, thoracic and mediastinal disorders42 (4.6)37 (4.0)31 (3.3)
 Gastrointestinal disorders16 (1.8)15 (1.6)18 (1.9)
 Nervous system disorders11 (1.2)3 (0.3)6 (0.6)
 Cardiac disorders2 (0.2)1 (0.1)8 (0.8)
Serious AEs, n (%)†373 (40.8)399 (43.5)409 (43.0)
 Respiratory, thoracic and mediastinal disorders198 (21.7)203 (22.1)212 (22.3)
 Infections and infestations118 (12.9)115 (12.5)110 (11.6)
 Neoplasms—benign, malignant and unspecified (including cysts and polyps)71 (7.8)73 (8.0)65 (6.8)
 Cardiac disorders50 (5.5)56 (6.1)71 (7.5)
 Nervous system disorders26 (2.8)31 (3.4)34 (3.6)
 General disorders and administration-site conditions18 (2.0)24 (2.6)30 (3.2)
 Renal and urinary disorders11 (1.2)12 (1.3)15 (1.6)
Patients with MACE, n (%)‡34 (3.7)31 (3.4)57 (6.0)
 Myocardial infarction8 (0.9)6 (0.7)11 (1.2)
 Cerebrovascular accident6 (0.7)6 (0.7)10 (1.1)
 Transient ischaemic attack4 (0.4)11 (1.2)6 (0.6)
Patients with MACE, n (%)§32 (3.5)31 (3.4)46 (4.8)
  • Two patients from centres with data irregularities were excluded.

  • *Includes thirty days after treatment stop.

  • †Frequency of patients with serious AEs, as determined by the investigator, occurring in 15 or more patients at the MedDRA (V.16.0) preferred term level by treatment and primary system organ class.

  • ‡Frequency of patients with AEs classified as MACE, as determined by the investigator, occurring in 10 or more patients at the preferred term level by treatment and primary system organ class.

  • §Frequency of patients with AEs classified as MACE based on adjudicated causes of death.

  • AE, adverse event; MACE, major adverse cardiovascular event (stroke, transient ischaemic attack, myocardial infarction, sudden death, cardiac death, sudden cardiac death or fatal event in the system organ classes for cardiac and vascular disorders); MedDRA, Medical Dictionary for Regulatory Activities.