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Table 4 Adverse event summary: short-term period and long-term extension

From: The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naïve patients with type 2 diabetes mellitus: a randomized controlled trial

  SAXA 2.5 mg q.A.M. (n = 74) SAXA 5 mg q.A.M. (n = 74) SAXA 2.5/5 mg q.A.M. (n = 71) SAXA 5 mg q.P.M. (n = 72) All SAXA (n = 291) Control (n = 74)
Adverse events n (%)*       
≥1 AE 49 (66.2) 54 (73.0) 53 (74.6) 51 (70.8) 207 (71.1) 41 (55.4)
≥1 related AE 17 (23.0) 17 (23.0) 14 (19.7) 10 (13.9) 58 (19.9) 11 (14.9)
Deaths 0 0 2 (2.8) 0 2 (0.7) 0
≥1 SAE 7 (9.5) 8 (10.8) 7 (9.9) 4 (5.6) 26 (8.9) 5 (6.8)
≥1 related SAE 1 (1.4) 0 0 0 1 (0.3) 1 (1.4)
Discontinuation due to AE 4 (5.4) 2 (2.7) 5 (7.0) 1 (1.4) 12 (4.1) 3 (4.1)
Discontinuation due to SAEs 1 (1.4) 0 2 (2.8) 0 3 (1.0) 2 (2.7)
Adverse events (≥5% All SAXA)       
URTI 11 (14.9) 10 (13.5) 11 (15.5) 11 (15.3) 43 (14.8) 7 (9.5)
Nasopharyngitis 3 (4.1) 4 (5.4) 3 (4.2) 5 (6.9) 15 (5.2) 3 (4.1)
Diarrhea 7 (9.5) 4 (5.4) 1 (1.4) 4 (5.6) 16 (5.5) 1 (1.4)
Pain in extremity 2 (2.7) 3 (4.1) 5 (7.0) 5 (6.9) 15 (5.2) 1 (1.4)
Reported hypoglycemia 3 (4.1) 6 (8.1) 6 (8.5) 6 (8.3) 21 (7.2) 3 (4.1)
Confirmed hypoglycemia** 0 1 (1.4) 0 1 (1.4) 2 (0.7) 1 (1.4)
Exposure, weeks, mean (SD)*** 54.6 (27.6) 62.2 (24.3) 56.8 (27.2) 59.8 (25.0) 58.8 (25.8)
  1. *Includes hypoglycemia
  2. Excludes hypoglycemia
  3. Reported hypoglycemia was defined as events consistent with signs or symptoms of hypoglycemia with or without documented blood glucose levels
  4. **Confirmed hypoglycemia defined as fingerstick glucose value ≤50 mg/dL in the presence of associated symptoms
  5. ***Exposure defined as the time from the first day to the last day, inclusive, that a patient took study medication. Exposure data includes rescue
  6. AE: adverse event; SAE: serious adverse event; SAXA: saxagliptin; SD: standard deviation; URTI: upper respiratory tract infection