Table 4.

Incidence of treatment-emergent serious adverse events during the entire 44-wk treatment period in at least 2% of subjects in any treatment group by MedDRA preferred term excluding data collected after dialysis (safety population analysis set)

TIW(n = 123)[n (%)]QW(n = 125)[n (%)]Q2W(n = 125)[n (%)]Total(n = 373)[n (%)]
Total no. subjects with serious adverse events36 (29)41 (33)42 (34)119 (32)
Cardiac failure congestive4 (3)4 (3)6 (5)14 (4)
Renal failure chronic4 (3)3 (2)5 (4)12 (3)
Hypoglycemia5 (4)4 (3)09 (2)
Myocardial infarction02 (2)5 (4)7 (2)
Renal failure acute2 (2)2 (2)3 (2)7 (2)
Pneumonia2 (2)2 (2)2 (2)6 (2)
Gastrointestinal hemorrhage1 (1)1 (1)3 (2)5 (1)
Hip fracture1 (1)1 (1)3 (2)5 (1)
Dehydration1 (1)1 (1)2 (2)4 (1)
Syncope1 (1)1 (1)2 (2)4 (1)
Urinary tract infection1 (1)1 (1)2 (2)4 (1)
Anemia02 (2)1 (1)3 (1)
Chest pain02 (2)1 (1)3 (1)
Deep vein thrombosis1 (1)02 (2)3 (1)
Dyspnea003 (2)3 (1)
Fall003 (2)3 (1)
Diarrhea002 (2)2 (1)
Osteoarthritis2 (2)002 (1)
Upper gastrointestinal hemorrhage02 (2)02 (1)
  • Incidence is based on the number of subjects experiencing at least one serious adverse event and not the number of events. SAEs within 30 days of the last dose were included. Adverse events that occurred on the same day as the initiation of dialysis were determined to have occurred before dialysis.

  • MedDRA, Medical Dictionary for Regulatory Activities; Q2W, every 2 wk; QW, once weekly; TIW, three times weekly