Summary of Liver Chemistry Elevation for Patients With Any Baseline Values in Phase III OASIS-1, OASIS-2, and OPTIC Studies (AC3 Pool)
| Parameter . | Omadacycline (n = 1073) . | Linezolid (n = 689) . | Moxifloxacin (n = 388) . |
|---|---|---|---|
| ALT (U/L), any value at baseline | n = 1031 | n = 659 | n = 381 |
| >3 × ULN | 44 (4.3) | 27 (4.1) | 17 (4.5) |
| >5 × ULN | 22 (2.1) | 5 (0.8) | 4 (1.0) |
| >10 × ULN | 9 (0.9) | 3 (0.5) | 1 (0.3) |
| AST (U/L), any value at baseline | n = 1040 | n = 661 | n = 379 |
| >3 × ULN | 38 (3.7) | 27 (4.1) | 12 (3.2) |
| >5 × ULN | 20 (1.9) | 7 (1.1) | 4 (1.1) |
| >10 × ULN | 6 (0.6) | 1 (0.2) | 2 (0.5) |
| Total bilirubin (µmol/L), any value at baseline | n = 1041 | n = 666 | n = 381 |
| >1.5 × ULN | 11 (1.1) | 3 (0.5) | 7 (1.8) |
| >2 × ULN | 6 (0.6) | 1 (0.2) | 4 (1.0) |
| Parameter . | Omadacycline (n = 1073) . | Linezolid (n = 689) . | Moxifloxacin (n = 388) . |
|---|---|---|---|
| ALT (U/L), any value at baseline | n = 1031 | n = 659 | n = 381 |
| >3 × ULN | 44 (4.3) | 27 (4.1) | 17 (4.5) |
| >5 × ULN | 22 (2.1) | 5 (0.8) | 4 (1.0) |
| >10 × ULN | 9 (0.9) | 3 (0.5) | 1 (0.3) |
| AST (U/L), any value at baseline | n = 1040 | n = 661 | n = 379 |
| >3 × ULN | 38 (3.7) | 27 (4.1) | 12 (3.2) |
| >5 × ULN | 20 (1.9) | 7 (1.1) | 4 (1.1) |
| >10 × ULN | 6 (0.6) | 1 (0.2) | 2 (0.5) |
| Total bilirubin (µmol/L), any value at baseline | n = 1041 | n = 666 | n = 381 |
| >1.5 × ULN | 11 (1.1) | 3 (0.5) | 7 (1.8) |
| >2 × ULN | 6 (0.6) | 1 (0.2) | 4 (1.0) |
Data are presented as No. (%).
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; OASIS, Omadacycline in Acute Skin and Skin Structure Infections Study; OPTIC, Omadacycline for Pneumonia Treatment In the Community; ULN, upper limit of normal.
Summary of Liver Chemistry Elevation for Patients With Any Baseline Values in Phase III OASIS-1, OASIS-2, and OPTIC Studies (AC3 Pool)
| Parameter . | Omadacycline (n = 1073) . | Linezolid (n = 689) . | Moxifloxacin (n = 388) . |
|---|---|---|---|
| ALT (U/L), any value at baseline | n = 1031 | n = 659 | n = 381 |
| >3 × ULN | 44 (4.3) | 27 (4.1) | 17 (4.5) |
| >5 × ULN | 22 (2.1) | 5 (0.8) | 4 (1.0) |
| >10 × ULN | 9 (0.9) | 3 (0.5) | 1 (0.3) |
| AST (U/L), any value at baseline | n = 1040 | n = 661 | n = 379 |
| >3 × ULN | 38 (3.7) | 27 (4.1) | 12 (3.2) |
| >5 × ULN | 20 (1.9) | 7 (1.1) | 4 (1.1) |
| >10 × ULN | 6 (0.6) | 1 (0.2) | 2 (0.5) |
| Total bilirubin (µmol/L), any value at baseline | n = 1041 | n = 666 | n = 381 |
| >1.5 × ULN | 11 (1.1) | 3 (0.5) | 7 (1.8) |
| >2 × ULN | 6 (0.6) | 1 (0.2) | 4 (1.0) |
| Parameter . | Omadacycline (n = 1073) . | Linezolid (n = 689) . | Moxifloxacin (n = 388) . |
|---|---|---|---|
| ALT (U/L), any value at baseline | n = 1031 | n = 659 | n = 381 |
| >3 × ULN | 44 (4.3) | 27 (4.1) | 17 (4.5) |
| >5 × ULN | 22 (2.1) | 5 (0.8) | 4 (1.0) |
| >10 × ULN | 9 (0.9) | 3 (0.5) | 1 (0.3) |
| AST (U/L), any value at baseline | n = 1040 | n = 661 | n = 379 |
| >3 × ULN | 38 (3.7) | 27 (4.1) | 12 (3.2) |
| >5 × ULN | 20 (1.9) | 7 (1.1) | 4 (1.1) |
| >10 × ULN | 6 (0.6) | 1 (0.2) | 2 (0.5) |
| Total bilirubin (µmol/L), any value at baseline | n = 1041 | n = 666 | n = 381 |
| >1.5 × ULN | 11 (1.1) | 3 (0.5) | 7 (1.8) |
| >2 × ULN | 6 (0.6) | 1 (0.2) | 4 (1.0) |
Data are presented as No. (%).
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; OASIS, Omadacycline in Acute Skin and Skin Structure Infections Study; OPTIC, Omadacycline for Pneumonia Treatment In the Community; ULN, upper limit of normal.
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