Table 3.
Safety profile in treatment period 1 (safety analysis set)
| All patients, n (%) | Mild renal impairment, n (%)* | Moderate renal impairment, n (%)* | ||||
|---|---|---|---|---|---|---|
| Ipragliflozin | Placebo | Ipragliflozin | Placebo | Ipragliflozin | Placebo | |
| Male patients/female patients/total patients | 93/26/119 | 36/10/46 | 46/15/61 | 20/3/23 | 47/11/58 | 16/7/23 |
| Patients with TEAEs | 97 (81.5) | 34 (73.9) | 49 (80.3) | 18 (78.3) | 48 (82.8) | 16 (69.6) |
| Number of TEAEs | 224 | 96 | 104 | 46 | 120 | 50 |
| Patients with SAEs | 8 (6.7) | 2 (4.3) | 5 (8.2) | 1 (4.3) | 3 (5.2) | 1 (4.3) |
| TEAEs leading to treatment discontinuation | 12 (10.1) | 4 (8.7) | 6 (9.8) | 1 (4.3) | 6 (10.3) | 3 (13.0) |
| TEAEs of special interest | ||||||
| TEAEs related to hypoglycaemia | 1 (0.8) | 0 | 0 | 0 | 1 (1.7) | 0 |
| TEAEs related to urinary tract infection | 1 (0.8) | 2 (4.3) | 0 | 0 | 1 (1.7) | 2 (8.7) |
| Males | 1 (1.1) | 0 | 0 | 0 | 1 (2.1) | 0 |
| Females | 0 | 2 (20.0) | 0 | 0 | 0 | 2 (28.6) |
| TEAEs related to genital infection | 1 (0.8) | 0 | 1 (1.6) | 0 | 0 | 0 |
| Males | 0 | 0 | 0 | 0 | 0 | 0 |
| Females | 1 (3.8) | 0 | 1 (6.7) | 0 | 0 | 0 |
| TEAEs related to polyuria or pollakiuria | 10 (8.4) | 2 (4.3) | 5 (8.2) | 2 (8.7) | 5 (8.6) | 0 |
eGFR, estimated glomerular filtration rate; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.
*
The severity of renal impairment was rated as mild (eGFR: 60 to <90 ml/min/1.73 m2) or moderate (eGFR: 30 to <60 ml/min/1.73 m2) based on the eGFR at visit 2.