|
|
|
Infection Type Days Skin and soft tissue (complicated) 10-14 Nosocomial pneumonia 10-14 Community-acquired pneumonia, inpatient 10-14 Community-acquired pneumonia, outpatient 10-14 Vancomycin-resistant Enterococcus faecium 14-28
Data are mean ± SD.
Hemoglobin (g/dl) Platelets (x 103/mm3) Neutrophils (x 103/mm3) Linezolid Comparator Linezolid Comparator Linezolid Comparator Baseline 12.93 ± 2.16 12.89 ± 2.26 260 ± 102 264 ± 111 7.86 ± 5.3 7.83 ± 5.0 Therapy days 1-7 12.73 ± 2.12 12.75 ± 2.11 290 ± 116 292 ± 116 5.8 ± 4.1 5.77 ± 3.6 Posttherapy days 1-7 13.06 ± 1.89 13.05 ± 2.03 284 ± 121 312 ± 121 4.93 ± 3.07 5.2 ± 3.7 Posttherapy days 15-21 12.96 ± 1.94 13.18 ± 1.94 292 ± 99 261 ± 94 4.89 ± 3.04 4.7 ± 2.7
aData are from 2045 patients enrolled in phase III studies of skin and soft tissue infections, community-acquired pneumonia, and nosocomial pneumonia, and treated with linezolid or comparator agents for 10-14 days.
LLN = lower limit of normal; BL = baseline; ULN = upper limit of normal.
Hematologic Test Criteria 1a Criteria 2b Hematocrit < 75% of LLN < 75% of BL (if BL > ULN)
< 90% of BL (if BL < LLN)Red blood cell count < 75% of LLN < 75% of BL (if BL > ULN)
< 90% of BL (if BL < LLN)Platelet count > 125% of ULN or < 75% of LLN > 125% of BL or < 75% of BL White blood cell count > 125% of ULN or < 75% of LLN > 125% of BL or < 75% of BL
aCriteria 1 are the clinical significance criteria when a patient'sbaseline value was normal.
bCriteria 2 are the clinical significance criteria when a patient's baseline value was abnormal.
Infection Type Days Skin and soft tissue (complicated) 10-14 Nosocomial pneumonia 10-14 Community-acquired pneumonia, inpatient 10-14 Community-acquired pneumonia, outpatient 10-14 Vancomycin-resistant Enterococcus faecium 14-28
Data are mean ± SD.
Hemoglobin (g/dl) Platelets (x 103/mm3) Neutrophils (x 103/mm3) Linezolid Comparator Linezolid Comparator Linezolid Comparator Baseline 12.93 ± 2.16 12.89 ± 2.26 260 ± 102 264 ± 111 7.86 ± 5.3 7.83 ± 5.0 Therapy days 1-7 12.73 ± 2.12 12.75 ± 2.11 290 ± 116 292 ± 116 5.8 ± 4.1 5.77 ± 3.6 Posttherapy days 1-7 13.06 ± 1.89 13.05 ± 2.03 284 ± 121 312 ± 121 4.93 ± 3.07 5.2 ± 3.7 Posttherapy days 15-21 12.96 ± 1.94 13.18 ± 1.94 292 ± 99 261 ± 94 4.89 ± 3.04 4.7 ± 2.7
aData are from 2045 patients enrolled in phase III studies of skin and soft tissue infections, community-acquired pneumonia, and nosocomial pneumonia, and treated with linezolid or comparator agents for 10-14 days.
LLN = lower limit of normal; BL = baseline; ULN = upper limit of normal.
Hematologic Test Criteria 1a Criteria 2b Hematocrit < 75% of LLN < 75% of BL (if BL > ULN)
< 90% of BL (if BL < LLN)Red blood cell count < 75% of LLN < 75% of BL (if BL > ULN)
< 90% of BL (if BL < LLN)Platelet count > 125% of ULN or < 75% of LLN > 125% of BL or < 75% of BL White blood cell count > 125% of ULN or < 75% of LLN > 125% of BL or < 75% of BL
aCriteria 1 are the clinical significance criteria when a patient'sbaseline value was normal.
bCriteria 2 are the clinical significance criteria when a patient's baseline value was abnormal.