The effect of diabetes mellitus on outcomes of patients with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: data from a prospective double-blind clinical trial comparing treatment with linezolid versus vancomycin

Table 3 Adverse events among diabetic and non-diabetic patients in the modified-intent-to-treat population

	Diabetic Patients (N = 183)		Non-diabetic Patients (N = 265)
Adverse event (AE) n (%)	Linezolid N = 87	Vancomycin N = 96	Linezolid N = 137	Vancomycin N = 128
Patients with a treatment- related AE	22 (25.3)	26 (27.1)	46 (33.6)	43 (33.6)
Patients with a serious AE	33 (37.9)	45 (46.9)	56 (40.9)	36 (28.1)
Patients with study drug discontinuation due to AE	3 (3.4)	8 (8.3)	9 (6.6)	9 (7.0)
Patients with specific AEs:
Diarrhea	12 (13.8)	14 (14.6)	28 (20.4)	20 (15.6)
Rash^a	6 (6.9)	8 (8.3)	16 (11.7)	9 (7.0)
Nausea	7 (8.0)	7 (7.3)	10 (7.3)	11 (8.6)
Vomiting	3 (3.4)	4 (4.2)	8 (5.8)	8 (6.3)
Thrombocytopenia^d	17 (20.7)	13 (14.3)	18 (13.5)	15 (12.3)
Kidney impairment^b	3 (3.4)	13 (13.5)	5 (3.6)	9 (7.0)
IV site complications^c	3 (3.4)	5 (5.2)	6 (4.4)	6 (4.7)

^aRash includes the following AE preferred terms: Genital rash, Rash, Rash erythematous, Rash generalized, Rash macular, Rash maculo-papular, Rash popular and Rash pustular
^bKidney Impairment includes the following AE preferred terms: Renal failure, Renal failure acute, Renal failure chronic and Renal impairment
^c IV Site Complications include the following AE preferred terms: Catheter site erythema, Catheter site haematoma, Catheter site haemorrhage, Catheter site infection, Catheter site pain, Infusion site cellulitis, Infusion site erythema, Infusion site extravasation, Infusion site infection, Infusion site phlebitis and Infusion site thrombosis
^dThrombocytopenia was defined as a platelet count of <150,000 μL, if platelet count was normal at baseline, or a 50 % drop if platelet count was not normal at baseline

ISSN: 1471-2334