Table 3.
Summary of overall safety and selected AEs
| Subjects, n (%) | ||||
|---|---|---|---|---|
| PBO (n = 89) | CANA 50 mg (n = 98) | CANA 100 mg (n = 93) | CANA 300 mg (n = 96) | |
| Any AE | 54 (61) | 73 (74) | 54 (58) | 60( 63) |
| AEs leading to discontinuation | 0 | 4 (4) | 3 (3) | 4 (4) |
| AEs related to study druga | 19 (21) | 34 (35) | 25 (27) | 28 (29) |
| Serious AEs | 0 | 2 (2) | 0 | 1 (1) |
| Most common AEs (≥5% in any treatment group) | ||||
| Urinary tract infection | 6 (7) | 10 (10) | 7 (8) | 8 (8) |
| Headache | 7 (8) | 6 (6) | 11 (12) | 4 (4) |
| Vulvovaginal mycotic infection | 1 (1) | 8 (8) | 5 (5) | 14 (15) |
| Upper respiratory tract infection | 5 (6) | 6 (6) | 6 (6) | 5 (5) |
| Nausea | 2 (2) | 7 (7) | 6 (6) | 3 (3) |
| Diarrhea | 5 (6) | 5 (5) | 3 (3) | 2 (2) |
| Constipation | 2 (2) | 5 (5) | 3 (3) | 2 (2) |
| Nasopharyngitis | 3 (3) | 6 (6) | 1 (1) | 1 (1) |
| Sinusitis | 0 | 6 (6) | 2 (2) | 1 (1) |
| Selected AEs of interest | ||||
| Genital mycotic infection | ||||
| Menb,c | 0 | 0 | 0 | 1 (1) |
| Womend,e | 3 (4) | 12 (14) | 10 (13) | 19 (22) |
| Osmotic diuresis-related AEsf | 2 (2) | 3 (3) | 3 (3) | 4 (4) |
| Symptomatic hypoglycemia | 2 (2) | 1 (1) | 0 | 2 (2) |
| Volume-related AEs | ||||
| Dizziness | 2 (2) | 4 (4) | 2 (2) | 4 (4) |
AE, adverse event; CANA, canagliflozin; PBO, placebo.
a
Possibly, probably, or very likely related to study drug, as assessed by investigators.
b
PBO, n = 14; CANA 50 mg, n = 12; CANA 100 mg, n = 17; CANA 300 mg, n = 10.
c
Including genital candidiasis.
d
PBO, n = 75; CANA 50 mg, n = 86; CANA 100 mg, n = 76; CANA 300 mg, n = 86.
e
Including vaginal candidiasis, vaginal infection, vaginitis bacterial, vulvovaginal mycotic infection, vaginal discharge, and vulvovaginal pruritus.
f
Including incontinence, micturition urgency, nocturia, pollakiuria, polyuria, stress urinary incontinence, and urge incontinence.