Table 3.
Summary of Treatment‐Emergent Adverse Events
| Canagliflozin 300 mg (n=56) | Canagliflozin 100 mg (n=57) | Placebo (n=56) | |
|---|---|---|---|
| Any AE | 15 (26.8) | 15 (26.3) | 11 (19.6) |
| AEs related to study druga | 10 (17.9) | 4 (7.0) | 3 (5.4) |
| AEs of special interest | |||
| Significant orthostasis at week 6b | 4 (7.1) | 2 (3.8) | 2 (3.9) |
| Volume depletionc | 2 (3.6) | 0 | 0 |
| Osmotic diuresisd | 5 (8.9) | 2 (3.5) | 3 (5.4) |
| Renale | 0 | 1 (1.8) | 0 |
| Genital mycotic infection | 0 | 0 | 0 |
| Urinary tract infection | 0 | 0 | 0 |
| Documented hypoglycemia | 5 (8.9) | 3 (5.3) | 4 (7.1) |
| AEs leading to discontinuation | 0 | 0 | 2 (3.6) |
| AEs related to study druga leading to discontinuation | 0 | 0 | 0 |
| Serious AEs | 0 | 0 | 1 (1.8) |
| Deaths | 0 | 0 | 0 |
Abbreviations: AE, adverse event; DBP, diastolic blood pressure; SBP, systolic blood pressure. Data are represented as number (percentage). Note: Percentages calculated with the number of patients in each group as denominator. aRelated to study drug includes relationship determined by investigators: possibly related, probably related, and very likely related. AEs related to canagliflozin 300 mg included fatigue, hypoglycemia, postural dizziness, nocturia, pollakiuria (n=3), polyuria, penile erythema, genital pruritus, and orthostatic hypotension; AEs related to canagliflozin 100 mg included diarrhea, increase in serum creatinine, hypoglycemia, micturition urgency, and pollakiuria. AEs related to placebo included dry mouth, hypoglycemia, dizziness, and nocturia. bSignificant orthostasis is defined as symptoms on standing (eg, dizziness, lightheadedness) or a reduction in office SBP ≥20 mm Hg or reduction in office DBP ≥15 mm Hg 2 minutes after standing. Sample sizes: placebo (n=51); canagliflozin 100 mg (n=53); canagliflozin 300 mg (n=56). cVolume depletion includes the following AEs: postural dizziness, dehydration, and/or orthostatic hypotension. dOsmotic diuresis includes the following AEs: dry mouth, micturition urgency, nocturia, pollakiuria (increased urinary frequency), and/or polyuria (increased urinary volume). eRenal related includes an increase in serum creatinine.