Table 3.
Overall safety and selected adverse events
| Patients, n (%) | |||
|---|---|---|---|
| PBO (n = 45) | CANA 100 mg (n = 42) | CANA 300 mg (n = 40) | |
| Any AEs | 30 (66.7) | 11 (26.2) | 18 (45.0) |
| AEs causing discontinuation | 0 | 1 (2.4) | 1 (2.5) |
| AEs related to study druga | 8 (17.8) | 3 (7.1) | 6 (15.0) |
| Serious AEs | 4 (8.9)b | 0 | 3 (7.5)c |
| Deaths | 0 | 0 | 0 |
| AEs of special interest | |||
| Genital mycotic infections | |||
| Male | 0 | 0 | 0 |
| Femaled,e | 0 | 1 (5.6) | 1 (5.6) |
| Urinary tract infections | 1 (2.2) | 1 (2.4) | 1 (2.5) |
| Osmotic diuresis-related events | |||
| Pollakiuria | 0 | 1 (2.4) | 2 (5.0) |
| Polyuria | 1 (2.2) | 1 (2.4) | 0 |
| Volume-related events | |||
| Postural dizziness | 0 | 0 | 0 |
| Orthostatic hypotension | 0 | 0 | 0 |
| Documented hypoglycemiaf,g | 2 (4.4) | 0 | 6 (15.0) |
| Severe hypoglycemia | 0 | 0 | 0 |
AE adverse event, CANA canagliflozin, PBO placebo
aPossibly, probably, or very likely related to study drug, as assessed by investigators
bIncluding asthma, atrioventricular block second degree, blood creatinine increased, diabetes mellitus, flank pain, and hyperglycemia
cIncluding angina pectoris, ankle fracture, colon cancer metastatic, and coronary artery disease
dThe proportions of female genital mycotic infections were calculated using the number of female patients in each treatment group, as follows: PBO, n = 19; CANA 100 mg, n = 18; CANA 300 mg, n = 18
eIncluding vaginal infection and vulvovaginitis
fAll documented hypoglycemia episodes are reported for prior to rescue therapy
gDocumented hypoglycemia included episodes that were biochemically documented (≤3.9 mmol/L) or severe (i.e., requiring the assistance of another individual or resulting in seizure or loss of consciousness)