Table 3.
Number of patients with AEs of interest
| Empagliflozin 25 mg/linagliptin 5 mg (n = 273) | Empagliflozin 10 mg/linagliptin 5 mg (n = 272) | Empagliflozin 25 mg (n = 276) | Empagliflozin 10 mg (n = 275) | Linagliptin 5 mg (n = 267) | |
|---|---|---|---|---|---|
| Confirmed hypoglycemic AEsa | 5 (1.8) | 3 (1.1) | 6 (2.2) | 6 (2.2) | 4 (1.5) |
| Events requiring assistance | 0 | 0 | 0 | 0 | 0 |
| Events consistent with urinary tract infectionb | 31 (11.4) | 34 (12.5) | 33 (12.0) | 38 (13.8) | 34 (12.7) |
| Female | 25 (19.5) | 27 (23.7) | 28 (21.2) | 29 (22.5) | 29 (23.2) |
| Male | 6 (4.1) | 7 (4.4) | 5 (3.5) | 9 (6.2) | 5 (3.5) |
| Events consistent with genital infectionc | 11 (4.0) | 12 (4.4) | 18 (6.5) | 18 (6.5) | 7 (2.6) |
| Female | 4 (3.1) | 9 (7.9) | 14 (10.6) | 11 (8.5) | 4 (3.2) |
| Male | 7 (4.8) | 3 (1.9) | 4 (2.8) | 7 (4.8) | 3 (2.1) |
| Events consistent with volume depletiond | 2 (0.7) | 5 (1.8) | 2 (0.7) | 1 (0.4) | 4 (1.5) |
| Dehydration | 1 (0.4) | 1 (0.4) | 1 (0.4) | 0 | 2 (0.7) |
| Hypotension | 1 (0.4) | 2 (0.7) | 0 | 1 (0.4) | 2 (0.7) |
| Syncope | 0 | 2 (0.7) | 2 (0.7) | 0 | 0 |
| Orthostatic hypotension | 0 | 0 | 0 | 0 | 1 (0.4) |
| Hypersensitivity reactionse | 3 (1.1) | 2 (0.7) | 2 (0.7) | 2 (0.7) | 1 (0.4) |
| Asthma | 0 | 1 (0.4) | 0 | 2 (0.7) | 0 |
| Urticaria | 0 | 1 (0.4) | 2 (0.7) | 0 | 0 |
| Angiodema | 1 (0.4) | 0 | 0 | 0 | 1 (0.4) |
| Asthmatic crisis | 1 (0.4) | 0 | 0 | 0 | 0 |
| Eyelid edema | 1 (0.4) | 0 | 0 | 0 | 0 |
| Pancreatitisf | 1 (0.4) | 0 | 0 | 0 | 1 (0.4) |
| Acute pancreatitis | 1 (0.4) | 0 | 0 | 0 | 0 |
| Chronic pancreatitis | 0 | 0 | 0 | 0 | 1 (0.4) |
| Decreased renal functiong | 1 (0.4) | 0 | 0 | 0 | 1 (0.4) |
| Acute renal failure | 0 | 0 | 0 | 0 | 1 (0.4) |
| Renal impairment | 1 (0.4) | 0 | 0 | 0 | 0 |
| Cancer events | 5 (1.8) | 2 (0.7) | 2 (0.7) | 2 (0.7) | 2 (0.7) |
| Adenoid cystic carcinoma | 0 | 0 | 0 | 1 (0.4) | 0 |
| Basal cell carcinoma | 1 (0.4) | 0 | 1 (0.4) | 0 | 0 |
| Breast cancer | 1 (0.4) | 0 | 0 | 0 | 0 |
| Renal cancerh | 2 (0.7) | 0 | 0 | 0 | 0 |
| Gastrointestinal carcinoma | 0 | 1 (0.4) | 0 | 0 | 0 |
| Lung canceri | 0 | 1 (0.4) | 0 | 1 (0.4) | 0 |
| Metastases to peritoneum | 0 | 0 | 1 (0.4) | 0 | 0 |
| Ovarian cancer | 0 | 0 | 1 (0.4) | 0 | 0 |
| Prostate cancerj | 1 (0.4) | 0 | 0 | 0 | 1 (0.4) |
| Squamous cell carcinoma | 0 | 0 | 0 | 0 | 1 (0.4) |
Data are number of patients (%) with ≥ 1 event in patients treated with ≥ 1 dose of study drug
SMQ standardized, MedDRA query Medical Dictionary for Regulatory Activities
aPlasma glucose ≤ 70 mg/dL and/or requiring assistance
bBased on 70 preferred terms
cBased on 89 preferred terms
dBased on 8 preferred terms
eBased on 3 SMQs
fBased on 1 SMQ and 1 preferred term
gBased on 1 SMQ
hBased on preferred terms: clear cell renal cell carcinoma/renal cancer
iBased on preferred terms: lung adenocarcinoma/lung neoplasm/non-small cell lung cancer metastatic
jBased on preferred terms: prostate cancer/prostatic specific antigen increased