Nebenwirkungen · Invokana
Invokana 100 mg film-coated tablets Invokana 300 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-128145 · Präparat HOS-096517
Table 3: Integrated analysis of amputations in CANVAS AND CANVAS-R Placebo canagliflozin N = 4344 N = 5790 Total number of subjects with events, n 47 (1.1) 140 (2.4) (%) Incidence rate (per 100 patient-years) 0.34 0.63 HR (95% CI) vs. placebo 1.97 (1.41, 2.75) Minor Amputation, n (%)* 34/47 (72.3) 99/140 (70.7) † Major Amputation, n (%) 13/47 (27.7) 41/140 (29.3) Note: Incidence is based on the number of patients with at least one amputation, and not the total number of amputation events. A patient’s follow-up is calculated from Day 1 to the first amputation event date. Some patients had more than one amputation. The percentage of minor and major amputations is based on the highest level amputation for each patient. * Toe and midfoot † Ankle, below knee and above knee
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