Table 2

Patients with AEs (safety population)

TITP
Treated patients177 (100.0)176 (100.0)
At least one AE108 (61.0)90 (51.1)
Severe AEs5 (2.8)11 (6.3)
Serious AEsa5 (2.8)9 (5.1)
Drug-related AEs48 (27.1)42 (23.9)
AEs leading to discontinuation of trial drug7 (4.0)9 (5.1)
Cough events42 (23.7)35 (19.9)
All hypoglycemic events120 (67.8)54 (30.7)
Severe hypoglycemic events9 (5.1)3 (1.7)
  • Data are n (%).

  • aIn TI group, serious AEs: 2 myocardial infarction, 1 urinary tract infection, 1 hypoglycemia, and 1 rectal carcinoma. Only hypoglycemia was considered related to the study drug. In TP group: 1 myocardial infarction, 1 angina pectoris, 1 coronary disease, 1 humerus fracture, 1 squamous cell carcinoma of the palate, 1 ischemic stroke, 1 back pain, 1 angioneurotic edema (due to ACE inhibitor), and 1 skull malformation. Only ischemic stroke was considered related to the study drug.