Table 3

Adverse events

<65 years≥65 years<75 years≥75 years
P
(n = 3,941)S
(n = 3,990)P value*P
(n = 4,271)S
(n = 4,290)P value*P
(n = 7,051)S
(n = 7,111)P value*P
(n = 1,161)S
(n = 1,169)P value*
% AEs (including hypoglycemia)
  ≥1 AE71.470.60.44675.776.50.36873.273.10.97176.476.90.774
  ≥1 treatment-related AE8.69.30.25910.612.20.0159.510.50.05410.012.70.042
 Death due to AE0.81.20.1292.02.40.2511.21.50.2122.83.80.171
  ≥1 SAE21.422.40.28729.429.20.89524.224.50.67533.934.90.624
  ≥1 treatment-related SAE0.30.80.0070.60.60.9870.60.70.2590.10.70.020
 Discontinued due to SAE(s)1.21.20.9512.61.90.0261.81.40.0432.82.70.878
 Discontinued due to AE(s)3.93.90.9036.05.80.6764.74.50.5546.67.30.544
% AEs (excluding hypoglycemia) reported by ≥5% of patients
 Hypertension3.84.80.0324.54.30.6414.04.60.1035.14.30.358
 Nausea2.42.30.7032.02.60.0662.32.30.8831.93.40.022
 Peripheral edema3.43.20.6325.25.10.9624.34.00.3214.45.60.166
 Renal impairment1.41.80.1442.42.30.8611.72.00.1913.12.50.364
 Urinary tract infection3.53.30.7725.34.80.3493.73.80.8358.45.90.021
% Hyperglycemia4.43.70.1103.72.70.0084.13.30.0113.62.40.084
% Hypoglycemia12.414.50.00614.416.00.04313.315.40.00114.114.50.774
 Major1.21.50.3192.12.70.0731.61.90.3062.23.90.017
 Only minor11.213.10.01112.413.40.16111.813.70.00112.010.90.376
% Pancreatitis
 Acute0.20.40.0780.20.20.4790.20.30.4050.10.11.000
 Chronic0.10.10.4500.00.00.4990.10.00.4510.10.00.498
% Neoplasms
 All cancers3.32.40.0125.45.40.9994.23.40.0205.77.00.188
 Pancreatic cancer0.10.10.4050.20.10.1300.20.00.0120.10.30.320
  • P, placebo; S, saxagliptin; SAE, serious adverse event.

  • 2 test.