Table 3.
Summary of overall safety and selected AEs *
|
Patients <65 y, n (%) |
Patients ≥65 y, n (%) |
|||||
|---|---|---|---|---|---|---|
|
PBO |
CANA 100 mg |
CANA 300 mg |
PBO |
CANA 100 mg |
CANA 300 mg |
|
| (n = 509) | (n = 674) | (n = 685) | (n = 137) | (n = 159) | (n = 149) | |
| Any AE |
300 (58.9) |
404 (59.9) |
404 (59.0) |
84 (61.3) |
97 (61.0) |
90 (60.4) |
| AEs leading to discontinuation |
14 (2.8) |
22 (3.3) |
22 (3.2) |
6 (4.4) |
14 (8.8) |
8 (5.4) |
| AEs related to study drug† |
66 (13.0) |
136 (20.2) |
155 (22.6) |
19 (13.9) |
35 (22.0) |
36 (24.2) |
| Serious AEs |
17 (3.3) |
17 (2.5) |
17 (2.5) |
5 (3.6) |
11 (6.9) |
5 (3.4) |
| Deaths |
1 (0.2) |
1 (0.1) |
1 (0.1) |
1 (0.7) |
0 |
0 |
| Selected AEs |
|
|
|
|
|
|
| UTI |
20 (3.9) |
41 (6.1) |
29 (4.2) |
6 (4.4) |
8 (5.0) |
7 (4.7) |
| Genital mycotic infection |
|
|
|
|
|
|
| Male‡,§ |
2 (0.8) |
14 (4.3) |
11 (3.4) |
0 |
3 (3.7) |
4 (5.2) |
| Female||,¶ |
10 (4.1) |
37 (10.7) |
44 (12.3) |
0 |
7 (9.0) |
5 (6.9) |
| Osmotic diuresis-related AEs# |
4 (0.8) |
44 (6.5) |
39 (5.7) |
1 (0.7) |
12 (7.5) |
8 (5.4) |
| Volume depletion-related AEs** |
5 (1.0) |
6 (0.9) |
8 (1.2) |
2 (1.5) |
4 (2.5) |
3 (2.0) |
| Renal-related AEs†† | 2 (0.4) | 2 (0.3) | 12 (1.8) | 2 (1.5) | 3 (1.9) | 2 (1.3) |
AE, adverse event; PBO, placebo; CANA, canagliflozin; UTI, urinary tract infection.
*All AEs are reported for regardless of rescue medication; hypoglycaemia episodes are reported for prior to rescue medication.
†Possibly, probably, or very likely related to study drug, as assessed by investigators.
‡For patients <65 years: PBO, n = 263; CANA 100 mg, n = 327; CANA 300 mg, n = 327; for patients ≥65 years: PBO, n = 71; CANA 100 mg, n = 81; CANA 300 mg, n = 77.
§Reported terms included balanitis, balanitis candida, balanoposthitis, and genital infection fungal in both age groups.
||For patients <65 years: PBO, n = 246; CANA 100 mg, n = 347; CANA 300 mg, n = 358; for patients ≥65 years: PBO, n = 66; CANA 100 mg, n = 78; CANA 300 mg, n = 72.
¶Reported terms included vaginal infection, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis in both age groups, and genital infection fungal and vulvitis in patients aged <65 years.
#Reported terms included micturition urgency, nocturia, pollakiuria, polyuria, dry mouth, polydipsia, and thirst in both age groups, and urine output increased in patients aged <65 years.
**Reported terms included dizziness postural, hypotension, and orthostatic hypotension in both age groups, and dehydration and syncope in patients aged <65 years.
††Reported terms included blood creatinine increased, glomerular filtration rate decreased, and renal impairment in both age groups, and renal failure acute in patients aged <65 years.