Creatinine 68 88 75 clearance mL/min Median 42-99 50-121 46-110 Interquartile range BVAS (RITUXVAS) BVAS/WG (RAVE) 8 7 8 19 18 median 6-10 5-10 6-10 14-24 12-25 Interquartile range Dialysis required 0 0 8* (24%) 1* (9%) 8 N (%) Use of plasma 0 0 8 (24%) 3 (27%) exchange N(%) Deaths 2 2 6 3*** 9 * The glomerular filtration rate was 0 ml per minute among patients who underwent dialysis. ** RB et al Rituximab versus Cyclophosphamide in ANCA-Associated Renal Vasculitis. N Engl J Med 2010, 363:211-20 *** Jones RB et al Verbal presentation of abstract 2010a Three deaths occurred during the first 6 months of treatment. Two patients in the CYC arm died of infections. One patient in the RTX arm died of multi-organ failure. One more death occurred in the RTX arm subsequently by the two year follow-up (Table 10). Table 10. Summary of deaths in RAVE Age Creatinine at Died Cause Entry (yrs) months from entry RTX unrelated 65 157 2 Multi-organ failure; considered μmol/L associated with the patient’s no dialysis underlying disease by the investigator RTX unrelated 78 16 Respiratory failure; investigator considers alveolar haemorrhage due to disease flare being life threatening, fatal, and unrelated to study medication, but rather related to a lack of efficacy. CYC Possibly 68 no dialysis 4 Pneumonia (multi-organ system failure with sepsis, due to
Creatinine clearance mL/min Median Interquartile range 68 42-99 88 50-121 75 46-110 BVAS (RITUXVAS) BVAS/WG (RAVE) median Interquartile range 8 6-10 7 5-10 8 6-10 19 14-24 18 12-25 Dialysis required N (%) 0 0 8* (24%) 1* (9%) 8 Use of plasma exchange N(%) 0 0 8 (24%) 3 (27%) Deaths 2 2 6 3*** 9 * The glomerular filtration rate was 0 ml per minute among patients who underwent dialysis. ** RB et al Rituximab versus Cyclophosphamide in ANCA-Associated Renal Vasculitis. N Engl J Med 2010, 363:211-20 *** Jones RB et al Verbal presentation of abstract 2010a Three deaths occurred during the first 6 months of treatment. Two patients in the CYC arm died of infections. One patient in the RTX arm died of multi-organ failure. One more death occurred in the RTX arm subsequently by the two year follow-up (Table 10). Table 10. Summary of deaths in RAVE Age (yrs) Creatinine at Entry Died months from entry Cause RTX unrelated 65 157 μmol/L no dialysis 2 Multi-organ failure; considered associated with the patient’s underlying disease by the investigator RTX unrelated 78 16 Respiratory failure; investigator considers alveolar haemorrhage due to disease flare being life threatening, fatal, and unrelated to study medication, but rather related to a lack of efficacy. CYC Possibly 68 no dialysis 4 Pneumonia (multi-organ system failure with sepsis, due to
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