. | <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 AE | 71.4 | 70.6 | 0.446 | 75.7 | 76.5 | 0.368 | 73.2 | 73.1 | 0.971 | 76.4 | 76.9 | 0.774 |
≥1 treatment-related AE | 8.6 | 9.3 | 0.259 | 10.6 | 12.2 | 0.015 | 9.5 | 10.5 | 0.054 | 10.0 | 12.7 | 0.042 |
Death due to AE | 0.8 | 1.2 | 0.129 | 2.0 | 2.4 | 0.251 | 1.2 | 1.5 | 0.212 | 2.8 | 3.8 | 0.171 |
≥1 SAE | 21.4 | 22.4 | 0.287 | 29.4 | 29.2 | 0.895 | 24.2 | 24.5 | 0.675 | 33.9 | 34.9 | 0.624 |
≥1 treatment-related SAE | 0.3 | 0.8 | 0.007 | 0.6 | 0.6 | 0.987 | 0.6 | 0.7 | 0.259 | 0.1 | 0.7 | 0.020 |
Discontinued due to SAE(s) | 1.2 | 1.2 | 0.951 | 2.6 | 1.9 | 0.026 | 1.8 | 1.4 | 0.043 | 2.8 | 2.7 | 0.878 |
Discontinued due to AE(s) | 3.9 | 3.9 | 0.903 | 6.0 | 5.8 | 0.676 | 4.7 | 4.5 | 0.554 | 6.6 | 7.3 | 0.544 |
% AEs (excluding hypoglycemia) reported by ≥5% of patients | ||||||||||||
Hypertension | 3.8 | 4.8 | 0.032 | 4.5 | 4.3 | 0.641 | 4.0 | 4.6 | 0.103 | 5.1 | 4.3 | 0.358 |
Nausea | 2.4 | 2.3 | 0.703 | 2.0 | 2.6 | 0.066 | 2.3 | 2.3 | 0.883 | 1.9 | 3.4 | 0.022 |
Peripheral edema | 3.4 | 3.2 | 0.632 | 5.2 | 5.1 | 0.962 | 4.3 | 4.0 | 0.321 | 4.4 | 5.6 | 0.166 |
Renal impairment | 1.4 | 1.8 | 0.144 | 2.4 | 2.3 | 0.861 | 1.7 | 2.0 | 0.191 | 3.1 | 2.5 | 0.364 |
Urinary tract infection | 3.5 | 3.3 | 0.772 | 5.3 | 4.8 | 0.349 | 3.7 | 3.8 | 0.835 | 8.4 | 5.9 | 0.021 |
% Hyperglycemia | 4.4 | 3.7 | 0.110 | 3.7 | 2.7 | 0.008 | 4.1 | 3.3 | 0.011 | 3.6 | 2.4 | 0.084 |
% Hypoglycemia | 12.4 | 14.5 | 0.006 | 14.4 | 16.0 | 0.043 | 13.3 | 15.4 | 0.001 | 14.1 | 14.5 | 0.774 |
Major | 1.2 | 1.5 | 0.319 | 2.1 | 2.7 | 0.073 | 1.6 | 1.9 | 0.306 | 2.2 | 3.9 | 0.017 |
Only minor | 11.2 | 13.1 | 0.011 | 12.4 | 13.4 | 0.161 | 11.8 | 13.7 | 0.001 | 12.0 | 10.9 | 0.376 |
% Pancreatitis | ||||||||||||
Acute | 0.2 | 0.4 | 0.078 | 0.2 | 0.2 | 0.479 | 0.2 | 0.3 | 0.405 | 0.1 | 0.1 | 1.000 |
Chronic | 0.1 | 0.1 | 0.450 | 0.0 | 0.0 | 0.499 | 0.1 | 0.0 | 0.451 | 0.1 | 0.0 | 0.498 |
% Neoplasms | ||||||||||||
All cancers | 3.3 | 2.4 | 0.012 | 5.4 | 5.4 | 0.999 | 4.2 | 3.4 | 0.020 | 5.7 | 7.0 | 0.188 |
Pancreatic cancer | 0.1 | 0.1 | 0.405 | 0.2 | 0.1 | 0.130 | 0.2 | 0.0 | 0.012 | 0.1 | 0.3 | 0.320 |
. | <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 AE | 71.4 | 70.6 | 0.446 | 75.7 | 76.5 | 0.368 | 73.2 | 73.1 | 0.971 | 76.4 | 76.9 | 0.774 |
≥1 treatment-related AE | 8.6 | 9.3 | 0.259 | 10.6 | 12.2 | 0.015 | 9.5 | 10.5 | 0.054 | 10.0 | 12.7 | 0.042 |
Death due to AE | 0.8 | 1.2 | 0.129 | 2.0 | 2.4 | 0.251 | 1.2 | 1.5 | 0.212 | 2.8 | 3.8 | 0.171 |
≥1 SAE | 21.4 | 22.4 | 0.287 | 29.4 | 29.2 | 0.895 | 24.2 | 24.5 | 0.675 | 33.9 | 34.9 | 0.624 |
≥1 treatment-related SAE | 0.3 | 0.8 | 0.007 | 0.6 | 0.6 | 0.987 | 0.6 | 0.7 | 0.259 | 0.1 | 0.7 | 0.020 |
Discontinued due to SAE(s) | 1.2 | 1.2 | 0.951 | 2.6 | 1.9 | 0.026 | 1.8 | 1.4 | 0.043 | 2.8 | 2.7 | 0.878 |
Discontinued due to AE(s) | 3.9 | 3.9 | 0.903 | 6.0 | 5.8 | 0.676 | 4.7 | 4.5 | 0.554 | 6.6 | 7.3 | 0.544 |
% AEs (excluding hypoglycemia) reported by ≥5% of patients | ||||||||||||
Hypertension | 3.8 | 4.8 | 0.032 | 4.5 | 4.3 | 0.641 | 4.0 | 4.6 | 0.103 | 5.1 | 4.3 | 0.358 |
Nausea | 2.4 | 2.3 | 0.703 | 2.0 | 2.6 | 0.066 | 2.3 | 2.3 | 0.883 | 1.9 | 3.4 | 0.022 |
Peripheral edema | 3.4 | 3.2 | 0.632 | 5.2 | 5.1 | 0.962 | 4.3 | 4.0 | 0.321 | 4.4 | 5.6 | 0.166 |
Renal impairment | 1.4 | 1.8 | 0.144 | 2.4 | 2.3 | 0.861 | 1.7 | 2.0 | 0.191 | 3.1 | 2.5 | 0.364 |
Urinary tract infection | 3.5 | 3.3 | 0.772 | 5.3 | 4.8 | 0.349 | 3.7 | 3.8 | 0.835 | 8.4 | 5.9 | 0.021 |
% Hyperglycemia | 4.4 | 3.7 | 0.110 | 3.7 | 2.7 | 0.008 | 4.1 | 3.3 | 0.011 | 3.6 | 2.4 | 0.084 |
% Hypoglycemia | 12.4 | 14.5 | 0.006 | 14.4 | 16.0 | 0.043 | 13.3 | 15.4 | 0.001 | 14.1 | 14.5 | 0.774 |
Major | 1.2 | 1.5 | 0.319 | 2.1 | 2.7 | 0.073 | 1.6 | 1.9 | 0.306 | 2.2 | 3.9 | 0.017 |
Only minor | 11.2 | 13.1 | 0.011 | 12.4 | 13.4 | 0.161 | 11.8 | 13.7 | 0.001 | 12.0 | 10.9 | 0.376 |
% Pancreatitis | ||||||||||||
Acute | 0.2 | 0.4 | 0.078 | 0.2 | 0.2 | 0.479 | 0.2 | 0.3 | 0.405 | 0.1 | 0.1 | 1.000 |
Chronic | 0.1 | 0.1 | 0.450 | 0.0 | 0.0 | 0.499 | 0.1 | 0.0 | 0.451 | 0.1 | 0.0 | 0.498 |
% Neoplasms | ||||||||||||
All cancers | 3.3 | 2.4 | 0.012 | 5.4 | 5.4 | 0.999 | 4.2 | 3.4 | 0.020 | 5.7 | 7.0 | 0.188 |
Pancreatic cancer | 0.1 | 0.1 | 0.405 | 0.2 | 0.1 | 0.130 | 0.2 | 0.0 | 0.012 | 0.1 | 0.3 | 0.320 |
P, placebo; S, saxagliptin; SAE, serious adverse event.
*χ2 test.