Table 3.
Summary of adverse events
| AEs | Group 1 (REM 100 mg; n = 224) | Group 2 (REM 250 mg; n = 241) | Group 3 (DAP 10 mg; n = 146) |
|---|---|---|---|
| TEAEs | 73 (32.6) | 83 (34.4) | 43 (29.5) |
| AEs leading to discontinuation | 3 (1.3) | 6 (2.5) | 2 (1.4) |
| AEs considered related to IP | 19 (8.5) | 33 (13.7) | 10 (6.8) |
| Serious AEs | 0 | 0 | 0 |
| AEs leading to death | 0 | 0 | 0 |
| AEs > 2% in any group | |||
| Pyrexia | 10 (4.5) | 3 (1.2) | 1 (0.7) |
| Bacteriuria | 4 (1.8) | 7 (2.9) | 2 (1.4) |
| Viral URTI | 1 (0.4) | 4 (1.7) | 3 (2.1) |
| Decreased GFR | 1 (0.4) | 7 (2.9) | 0 |
| Dyslipidemia | 3 (1.3) | 5 (2.1) | 5 (3.4) |
| Pain in extremity | 1 (0.4) | 2 (0.8) | 3 (2.1) |
| Dizziness | 1 (0.4) | 1 (0.4) | 3 (2.1) |
| Headache | 4 (1.8) | 8 (3.3) | 5 (3.4) |
| Ketonuria | 6 (2.7) | 2 (0.8) | 1 (0.7) |
| Cough | 2 (0.9) | 5 (2.1) | 3 (2.1) |
| UTI | |||
| Male | 5 (2.2) | 4 (1.7) | 1 (0.7) |
| Female | 2 (0.9) | 12 (5.0) | 2 (1.4) |
| AEs of special interest | |||
| Hypoglycemia | 3 (1.3) | 1 (0.4) | 2 (1.4) |
| Vulvovaginitis, balanitis, and related genital infections | 4 (1.8) | 3 (1.2) | 4 (2.7) |
| UTI | 7 (3.1) | 16 (6.6) | 3 (2.1) |
Data are presented as n (%)
AEs adverse events, DAP dapagliflozin, GFR glomerular filtration rate, IP investigational product, REM remogliflozin, TEAEs treatment-emergent AEs, URTI upper respiratory tract infection, UTI urinary tract infection