during early and late follow-up. Gram-negative infections included cholangitis, alcoholic pancreatitis, sternal osteomyelitis/mediastinitis, bowel infarction, recurrent Crohn's disease, recurrent line sepsis, and recurrent urosepsis caused by a number of different Gram-negative bacteria.
The rates of the most common adverse reactions, organized by System Organ Class (SOC), observed in S. aureus bacteremia/endocarditis (6 mg/kg CUBICIN) patients are displayed in Table 5.
The following reactions, not included above, were reported as possibly or probably drug-related in the CUBICIN-treated group:
Blood and Lymphatic System Disorders: eosinophilia, lymphadenopathy, thrombocythemia, thrombocytopenia
Cardiac Disorders: atrial fibrillation, atrial flutter, cardiac arrest
Ear and Labyrinth Disorders: tinnitus
Eye Disorders: vision blurred
Gastrointestinal Disorders: dry mouth, epigastric discomfort, gingival pain, hypoesthesia oral
Infections and Infestations: candidal infection NOS, vaginal candidiasis, fungemia, oral candidiasis, urinary tract infection fungal
Investigations: blood phosphorous increased, blood alkaline phosphatase increased, INR increased, liver function test abnormal, alanine aminotransferase increased, aspartate aminotransferase increased, prothrombin time prolonged
Metabolism and Nutrition Disorders: appetite decreased NOS
Musculoskeletal and Connective Tissue Disorders: myalgia
Nervous System Disorders: dyskinesia, paresthesia
Psychiatric Disorders: hallucination NOS
Renal and Urinary Disorders: proteinuria, renal impairment NOS
Skin and Subcutaneous Tissue Disorders: pruritus generalized, rash vesicular
Table 5. Incidence of Adverse Reactions that Occurred in ≥5% of Patients in the CUBICIN Treatment Group and ≥ to the Comparator Treatment Group in the S. aureus Bacteremia/Endocarditis Trial Adverse ReactionNOS, not otherwise specified. Patients
n (%)
CUBICIN 6 mg/kg
(N=120) ComparatorComparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 2 g IV q4h), each with initial low-dose gentamicin.
(N=116)
Infections and infestations
Sepsis NOS 6 (5%) 3 (3%)
Bacteremia 6 (5%) 0 (0%)
Gastrointestinal disorders
Abdominal pain NOS 7 (6%) 4 (3%)
General disorders and administration site conditions
Chest pain 8 (7%) 7 (6%)
Edema NOS 8 (7%) 5 (4%)
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain 10 (8%) 2 (2%)
Skin and subcutaneous tissue disorders
Pruritus 7 (6%) 6 (5%)
Sweating increased 6 (5%) 0 (0%)
Psychiatric disorders
Insomnia 11 (9%) 8 (7%)
Investigations
Blood creatine phosphokinase increased 8 (7%) 1 (1%)
Vascular disorders
Hypertension NOS 7 (6%) 3 (3%)
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