Table 3.
Adverse events in VERTIS CV patients with CKD stage 3*
| Adverse event† | Placebo (N=597)‡ |
Ertugliflozin 5 mg (N=617)‡ |
Ertugliflozin 15 mg (N=560)‡ |
| Any AE—n (%) | 535 (89.6) | 561 (90.9) | 501 (89.5) |
| Serious AEs—n (%) | 250 (41.9) | 252 (40.8) | 222 (39.6) |
| AEs leading to discontinuation of study drug—n (%) | 51 (8.5) | 66 (10.7) | 54 (9.6) |
| Deaths—n (%) | 28 (4.7) | 34 (5.5) | 30 (5.4) |
| Prespecified AEs of interest—n (%) | |||
| Urinary tract infection | 77 (12.9) | 85 (13.8) | 79 (14.1) |
| Genital mycotic infection—women§ | 8 (3.9) | 9 (4.1) | 17 (8.1) |
| Genital mycotic infection—men¶ | 1 (0.3) | 12 (3.0) | 13 (3.7) |
| Symptomatic hypoglycemia** | 224 (37.5) | 232 (37.6) | 193 (34.5) |
| Hypovolemia | 39 (6.5) | 44 (7.1) | 33 (5.9) |
| Kidney-related AEs—n (%) | |||
| Any kidney-related AE | 61 (10.2) | 60 (9.7) | 56 (10.0) |
| Acute kidney injury | 32 (5.4) | 23 (3.7) | 30 (5.4) |
| Kidney failure | 17 (2.8) | 14 (2.3) | 11 (2.0) |
| Kidney impairment | 18 (3.0) | 28 (4.5) | 17 (3.0) |
| Adjudicated kidney events—n (%) | |||
| Any adjudicated kidney event | 24 | 16 | 21 |
| Causality | |||
| Very likely | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Probable | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Possible | 4 (16.7) | 0 (0.0) | 3 (14.3) |
| Doubtful | 7 (29.2) | 10 (62.5) | 8 (38.1) |
| Not related | 13 (54.2) | 6 (37.5) | 10 (47.6) |
*CKD stage was based on eGFR calculated using the MDRD equation.
†All events occurring within 14 days of final dose of treatment and including events after initiation of glycemic rescue medication, except for those related to hypoglycemia.
‡N is the number of patients in the safety analysis population (ie, patients who took at least one dose of study medication).
§Number of women with CKD stage 3: placebo, n=203; ertugliflozin 5 mg, n=222; ertugliflozin 15 mg, n=209.
¶Number of men with CKD stage 3: placebo, n=394; ertugliflozin 5 mg, n=395; ertugliflozin 15 mg, n=351.
**Symptomatic hypoglycemia was defined as an event with clinical symptoms reported by the investigator as hypoglycemia (biochemical documentation not required).
AE, adverse event; CKD, chronic kidney disease; CKD stage 3, eGFR 30–<60 mL/min/1.73 m2; eGFR, estimated glomerular filtration rate; MDRD, Modification of Diet in Renal Disease.