Table 2.
Adverse events in Asian patients
| Adverse eventa | Linagliptin (n = 272) | Placebo (n = 283) |
|---|---|---|
| Any adverse event | 212 (77.9) | 240 (84.8) |
| Serious adverse event | 106 (39.0) | 131 (46.3) |
| Adverse event leading to discontinuation | 19 (7.0) | 23 (8.1) |
| Renal and urinary disordersb | 16 (5.9) | 13 (4.6) |
| Constipationc | 15 (5.5) | 19 (6.7) |
| Hypersensitivity reactionsd | 11 (4.0) | 16 (5.7) |
| Cancere | 5 (1.8) | 7 (2.5) |
| Colon cancer | 1 (0.4) | 0 |
| Pancreatic cancerf | 0 | 1 (0.4) |
| Gastric cancer | 0 | 0 |
| Pancreatitis (adjudication-confirmed) | 0 | 0 |
| Pemphigoid | 0 | 0 |
| Skin lesionsg | 0 | 0 |
Data are n (%) of patients treated with ≥ 1 dose of study medication
MedDRA Version 20.1 was used to code adverse events
BIcMQ Boehringer Ingelheim customized MedDRA Query, MedDRA Medical Dictionary for Regulatory Activities, SMQ standardized MedDRA query
aMedDRA preferred term unless otherwise specified
bBased on the narrow SMQ “acute renal failure”
cBased on the preferred terms “Constipation” and “Infrequent bowel movements”
dBased on the narrow SMQ “hypersensitivity”
eBased on SMQs “Malignant Tumors” and “Tumors of unspecified malignancy”
fBased on narrow BIcMQ “Pancreatic cancer”
gBased on the narrow SMQ “Severe cutaneous adverse reactions”