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Table 3 Overall safety summary

From: Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data

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
  1. CV cardiovascular, PBO placebo, CANA canagliflozin, AE adverse event
  2. aPossibly, probably, or very likely related to study drug, as assessed by investigators