Table 4.
Summary of AEs
| Patients, n (%) | SU (n=159) | CANA (n=162) |
|---|---|---|
| Any AEs | 29 (18.2) | 37 (22.8) |
| AEs leading to discontinuation | 0 | 0 |
| AEs related to study drug | 14 (8.8) | 15 (9.3) |
| Serious AEs | 0 | 0 |
| Deaths | 0 | 0 |
| Genital mycotic infections | ||
| Male | 0 | 0 |
| Female | 0 | 0 |
| Urinary tract infections | 0 | 1 (0.6) |
| Osmotic diuresis–related AEsa | 0 | 10 (6.2) |
| Volume depletion–related AEsb | 6 (3.8) | 15 (9.3)c |
| Hypoglycaemia AEs | 17 (10.7) | 4 (2.5) |
AE, adverse event; SU, sulphonylurea; CANA, canagliflozin.
a
Includes thirst.
b
Includes dehydration, postural dizziness, and hypovolaemia.
c
One patient reported two volume depletion–related AEs.