Table 3.
Overall safety summary
| Patients, n (%) | History of CV disease | History of hypertension | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yes | No | Yes | No | |||||||||
| PBO (n = 40) |
CANA 100 mg (n = 59) |
CANA 300 mg (n = 56) |
PBO (n = 606) |
CANA 100 mg (n = 774) |
CANA 300 mg (n = 778) |
PBO (n = 409) |
CANA 100 mg (n = 518) |
CANA 300 mg (n = 506) |
PBO (n = 237) |
CANA 100 mg (n = 315) |
CANA 300 mg (n = 328) |
|
| Any AE | 27 (67.5) | 32 (54.2) | 42 (75.0) | 357 (58.9) | 469 (60.6) | 452 (58.1) | 253 (61.9) | 300 (57.9) | 298 (58.9) | 131 (55.3) | 201 (63.8) | 196 (59.8) |
| AEs leading to discontinuation | 0 | 4 (6.8) | 3 (5.4) | 20 (3.3) | 32 (4.1) | 27 (3.5) | 13 (3.2) | 25 (4.8) | 23 (4.5) | 7 (3.0) | 11 (3.5) | 7 (2.1) |
| AEs related to study druga | 5 (12.5) | 8 (13.6) | 18 (32.1) | 80 (13.2) | 163 (21.1) | 173 (22.2) | 62 (15.2) | 101 (19.5) | 111 (21.9) | 23 (9.7) | 70 (22.2) | 80 (24.4) |
| Serious AEs | 2 (5.0) | 2 (3.4) | 4 (7.1) | 20 (3.3) | 26 (3.4) | 18 (2.3) | 19 (4.6) | 17 (3.3) | 11 (2.2) | 3 (1.3) | 11 (3.5) | 11 (3.4) |
| Deaths | 0 | 0 | 1 (1.8) | 2 (0.3) | 1 (0.1) | 0 | 2 (0.5) | 1 (0.2) | 1 (0.2) | 0 | 0 | 0 |
| Patients, n (%) | Baseline statin use | CV risk factors | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yes | No | 0–1 | ≥2 | |||||||||
| PBO (n = 266) |
CANA 100 mg (n = 339) |
CANA 300 mg (n = 340) |
PBO (n = 380) |
CANA 100 mg (n = 494) |
CANA 300 mg (n = 494) |
PBO (n = 468) |
CANA 100 mg (n = 616) |
CANA 300 mg (n = 643) |
PBO (n = 178) |
CANA 100 mg (n = 217) |
CANA 300 mg (n = 191) |
|
| Any AE | 168 (63.2) | 212 (62.5) | 220 (64.7) | 216 (56.8) | 289 (58.5) | 274 (55.5) | 275 (58.8) | 380 (61.7) | 381 (59.3) | 109 (61.2) | 121 (55.8) | 113 (59.2) |
| AEs leading to discontinuation | 8 (3.0) | 17 (5.0) | 17 (5.0) | 12 (3.2) | 19 (3.8) | 13 (2.6) | 14 (3.0) | 23 (3.7) | 24 (3.7) | 6 (3.4) | 13 (6.0) | 6 (3.1) |
| AEs related to study druga | 42 (15.8) | 75 (22.1) | 95 (27.9) | 43 (11.3) | 96 (19.4) | 96 (19.4) | 61 (13.0) | 130 (21.1) | 148 (23.0) | 24 (13.5) | 41 (18.9) | 43 (22.5) |
| Serious AEs | 12 (4.5) | 13 (3.8) | 12 (3.5) | 10 (2.6) | 15 (3.0) | 10 (2.0) | 13 (2.8) | 18 (2.9) | 17 (2.6) | 9 (5.1) | 10 (4.6) | 5 (2.6) |
| Deaths | 1 (0.4) | 0 | 0 | 1 (0.3) | 1 (0.2) | 1 (0.2) | 2 (0.4) | 0 | 1 (0.2) | 0 | 1 (0.5) | 0 |
CV cardiovascular, PBO placebo, CANA canagliflozin, AE adverse event
aPossibly, probably, or very likely related to study drug, as assessed by investigators