Table 2.
AEs associated with canagliflozin that occurred in ≥2% of canagliflozin-treated patients
| AE | Patients, n (%)
|
||
|---|---|---|---|
| PBO (n=646) | CANA 100 mg (n=833) | CANA 300 mg (n=834) | |
| Gastrointestinal AEs | |||
| Constipation | 6 (0.9) | 15 (1.8) | 19 (2.3) |
| Nausea | 10 (1.5) | 18 (2.2) | 19 (2.3) |
| AEs related to osmotic diuresis | |||
| Thirsta | 1 (0.2) | 23 (2.8) | 19 (2.3) |
| Increased urinationb | 5 (0.8) | 44 (5.3) | 38 (4.6) |
| Urinary tract infectionc | 26 (4.0) | 49 (5.9) | 36 (4.3) |
| Genital AEs | |||
| Female genital | 10 (3.2) | 44 (10.4) | 49 (11.4) |
| mycotic infectiond,e | |||
| Vulvovaginal pruritusd | 0 | 7 (1.6) | 13 (3.0) |
| Male genital | 2 (0.6) | 17 (4.2) | 15 (3.7) |
| mycotic infectionf,g | |||
Notes:
Includes thirst, dry mouth, and polydipsia;
includes polyuria, pollakiuria, urine output increased, micturition urgency, and nocturia;
includes urinary tract infection, cystitis, kidney infection, and urosepsis;
percentages based on the number of females in each treatment group (PBO, n=312; CANA 100 mg, n=425; CANA 300 mg, n=430);
includes vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis, vaginal infection, vulvitis, and genital infection fungal;
percentages based on the number of males in each treatment group (PBO, n=334; CANA 100 mg, n=408; CANA 300 mg, n=404);
includes balanitis or balanoposthitis, balanitis candida, and genital infection fungal. Adapted from Safety and tolerability of canagliflozin in patients with type 2 diabetes: pooled analysis of phase 3 study results. Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Postgraduate Medicine. 2014;126(3):16–34. Taylor & Francis. Reprinted by permission of Taylor & Francis Ltd, http://www.tandfonline.com.43
Abbreviations: AE, adverse event; PBO, placebo; CANA, canagliflozin.