Table 2.
Adverse events in Asian patients
| Adverse event | Linagliptin (n = 465) | Glimepiride (n = 468) |
|---|---|---|
| Any adverse event | 443 (95.3) | 453 (96.8) |
| Serious adverse event | 213 (45.8) | 240 (51.3) |
| Adverse event leading to discontinuation | 54 (11.6) | 66 (14.1) |
| Any hospitalization | 184 (39.6) | 228 (48.7) |
| Hypersensitivity reactionsa | 87 (18.7) | 80 (17.1) |
| Pemphigoidb | 1 (0.2) | 0 |
| Skin lesionsc | 1 (0.2) | 0 |
| Acute pancreatitis (adjudication-confirmed) | 3 (0.6) | 2 (0.4) |
| Chronic pancreatitis (adjudication-confirmed) | 1 (0.2) | 0 |
| Cancerd | 22 (4.7) | 33 (7.1) |
| Colorectal cancere | 2 (0.4) | 5 (1.1) |
| Pancreatic cancer (adjudication-confirmed) | 3 (0.6) | 2 (0.4) |
| Gastric cancerf | 5 (1.1) | 1 (0.2) |
| Thyroid cancerg | 1 (0.2) | 0 |
Data are n (%) of patients treated with ≥ 1 dose of study medication until 7 days after the last intake of study medication except for hospitalization, pancreatitis and cancers, which include all events until study end
MedDRA Version 21.0 was used to classify adverse events
MedDRA Medical Dictionary for Regulatory Activities, SMQ Standardised MedDRA Query
aBased on the narrow SMQ “hypersensitivity”
bMedDRA preferred term
cBased on narrow SMQ “Severe cutaneous adverse reactions”
dBased on narrow SMQs “Malignant Tumors” and “Tumors of unspecified malignancy”
eMedDRA high-level term “Colorectal neoplasms malignant”
fMedDRA high-level term “Gastric neoplasms malignant”
gMedDRA high-level term “Thyroid neoplasms malignant”