| Placebo | Canagliflozin 100 mg | ||
---|---|---|---|---|
(NÂ =Â 71) | (NÂ =Â 75) | |||
n (%) | 95Â % CI | n (%) | 95Â % CI | |
Adverse events | 46 (64.8) | 52.5–75.8 | 51 (68.0) | 56.2–78.3 |
Adverse drug reactions | 16 (22.5) | 13.5–34.0 | 30 (40.0) | 28.9–52.0 |
Serious adverse events | 1 (1.4) | 0.0–7.6 | 3 (4.0) | 0.8–11.2 |
Serious adverse drug reactions | 0 (0.0) | 0.0–5.1 | 0 (0.0) | 0.0–4.8 |
Adverse events leading to discontinuation | 0 (0.0) | 0.0–5.1 | 1 (1.3) | 0.0–7.2 |
Adverse drug reactions leading to discontinuation | 0 (0.0) | 0.0–5.1 | 0 (0.0) | 0.0–4.8 |
Deaths | 0 (0.0) | 0.0–5.1 | 0 (0.0) | 0.0–4.8 |
AEs of special interest | ||||
 Documented hypoglycemiaa | 21 (29.6) |  | 30 (40.0) |  |
  Hypoglycemia | 15 (21.1) |  | 19 (25.3) |  |
  Blood glucose decreased | 11 (15.5) |  | 20 (26.7) |  |
Urinary tract infection | 0 (0) | Â | 1 (1.3) | Â |
 Cystitis | 0 (0) |  | 1 (1.3) |  |
Osmotic diuresis | 2 (2.8) | Â | 4 (5.3) | Â |
 Pollakiuria | 1 (1.4) |  | 4 (5.3) |  |
 Polyuria | 0 (0) |  | 3 (4.0) |  |
 Thirst | 1 (1.4) |  | 1 (1.3) |  |
Fracture | 1 (1.4) | Â | 0 (0) | Â |
 Foot Fracture | 1 (1.4) |  | 0 (0) |  |
Skin disorder | 0 (0) | Â | 2 (2.7) | Â |
 Seborrheic dermatitis | 0 (0) |  | 1 (1.3) |  |
 Urticaria | 0 (0) |  | 1 (1.3) |  |
Ketone bodies | 2 (2.8) | Â | 3 (4.0) | Â |
 Blood ketone bodies increased | 2 (2.8) |  | 3 (4.0) |  |
(Number of female patients) | (NÂ =Â 22) | Â | (NÂ =Â 31) | Â |
Vulvovaginitis | 0 (0) | Â | 1 (3.2) | Â |
 Genital candidiasis | 0 (0) |  | 1 (3.2) |  |