Table 4.
AEs of interest
| Patients with ≥ 1 event | Placebo pool | Broad pool | ||||
|---|---|---|---|---|---|---|
| Placebo (n = 515) | Ertugliflozin 5 mg (n = 519) | Ertugliflozin 15 mg (n = 510) | Non-ertugliflozin (n = 1448) | Ertugliflozin 5 mg (n = 1713) | Ertugliflozin 15 mg (n = 1688) | |
| Osmotic diuresis AE | 5 (1.0) | 15 (2.9) | 12 (2.4) | 20 (1.4) | 47 (2.7) | 38 (2.3) |
| Volume depletion AE | 9 (1.7) | 4 (0.8) | 5 (1.0) | 18 (1.2) | 33 (1.9) | 28 (1.7) |
| Renal-related AE | 2 (0.4) | 2 (0.4) | 1 (0.2) | 7 (0.5) | 11 (0.6) | 14 (0.8) |
| GMI AE | ||||||
| Female | 7/235 (3.0) | 23/252 (9.1)a | 30/245 (12.2)a | 20/661 (3.0) | 76/828 (9.2) | 94/844 (11.1) |
| Male | 1/280 (0.4) | 10/267 (3.7)a | 11/265 (4.2)a | 3/787 (0.4) | 43/885 (4.9) | 33/844 (3.9) |
| Complicated genital infection AE | ||||||
| Female | – | – | – | 2/661 (0.3) | 2/828 (0.2) | 1/844 (0.1) |
| Male | – | – | – | 1/787 (0.1) | 3/885 (0.3) | 8/844 (0.9) |
| UTI AE | 20 (3.9) | 21 (4.0) | 21 (4.1) | 123 (8.5) | 127 (7.4) | 139 (8.2) |
| Complicated UTI AE | – | – | – | 5 (0.3) | 4 (0.2) | 10 (0.6) |
| Hypoglycemia | ||||||
| Documented (symptomatic or asymptomatic) | 15 (2.9) | 26 (5.0) | 23 (4.5) | – | – | – |
| Severe | 2 (0.4) | 2 (0.4) | 2 (0.4) | – | – | – |
| Amputationb | – | – | – | 1 (0.1) | 3 (0.2) | 8 (0.5) |
| Ketoacidosisb,c | – | – | – | 0 | 0 | 3 (0.2) |
| Fractured | – | – | – | 12 (0.8) | 15 (0.9) | 11 (0.7) |
| Pancreatitisd | – | – | – | 2 (0.1) | 1 (0.1) | 0 |
| Potential hypersensitivity AE | – | – | – | 44 (3.0) | 60 (3.5) | 46 (2.7) |
| Malignant or unspecified tumor AE with onset > 180 days after first dosee | – | – | – | 10/1373 (0.7) | 7/1652 (0.4) | 18/1607 (1.1) |
| Malignant or unspecified tumor AEb | – | – | – | 10 (0.7) | 12 (0.7) | 24 (1.4) |
Data are n (%), except for GMIs, which are n/N (%), with n representing the number of patients and N representing the total number of females or males in that group. All data include rescue therapy, except hypoglycemia (excludes data after the initiation of rescue therapy). All events are during the treatment period (except where indicated†). AEs were coded according to the Medical Dictionary for Regulatory Activities [MedDRA: version 18.1 during the studies and versions 19.0 (placebo pool) and 20.1 (broad pool) during the pooled analyses], with definitions based on prespecified Custom MedDRA Query, Standard MedDRA Query, or program definition (see supplementary information for details of the preferred terms)
AE adverse event, GMI genital mycotic infection, UTI urinary tract infection
– Analysis was not conducted in this pool
a P < 0.05 vs. placebo group
b All post-randomization follow-up period
c Includes those patients assessed as meeting the case definition of ketoacidosis with certain, probable, or possible likelihood
d Cases confirmed by adjudication
e Includes the all post-randomization follow-up period for patients treated > 180 days