Occurrence of Other Tetracycline-class Events of Interest in Phase III OASIS-1, OASIS-2, and OPTIC Studies (AC3 Pool)
| TEAE . | Omadacycline (n = 1073) . | Linezolid (n = 689) . | Moxifloxacin (n = 388) . |
|---|---|---|---|
| Hypersensitivity reactions | 20 (1.9) | 12 (1.7) | 10 (2.6) |
| Fungal infections | 11 (1.0) | 6 (0.9) | 5 (1.3) |
| Vestibular disorders | 9 (0.8) | 6 (0.9) | 4 (1.0) |
| Blood urea increased | 1 (0.1) | 0 | 0 |
| Esophageal disorders | 1 (0.1) | 0 | 0 |
| Pancreatitis | 1 (0.1) | 0 | 1 (0.3) |
| TEAE . | Omadacycline (n = 1073) . | Linezolid (n = 689) . | Moxifloxacin (n = 388) . |
|---|---|---|---|
| Hypersensitivity reactions | 20 (1.9) | 12 (1.7) | 10 (2.6) |
| Fungal infections | 11 (1.0) | 6 (0.9) | 5 (1.3) |
| Vestibular disorders | 9 (0.8) | 6 (0.9) | 4 (1.0) |
| Blood urea increased | 1 (0.1) | 0 | 0 |
| Esophageal disorders | 1 (0.1) | 0 | 0 |
| Pancreatitis | 1 (0.1) | 0 | 1 (0.3) |
Data are presented as No. (%). A TEAE was defined as an adverse event with a start date/time on or after the date/time of the first dose of active study drug. If a patient had >1 TEAE with the same category, the patient was counted only once for that category.
Abbreviations: OASIS, Omadacycline in Acute Skin and Skin Structure Infections Study; OPTIC, Omadacycline for Pneumonia Treatment In the Community; TEAE, treatment-emergent adverse event.
Occurrence of Other Tetracycline-class Events of Interest in Phase III OASIS-1, OASIS-2, and OPTIC Studies (AC3 Pool)
| TEAE . | Omadacycline (n = 1073) . | Linezolid (n = 689) . | Moxifloxacin (n = 388) . |
|---|---|---|---|
| Hypersensitivity reactions | 20 (1.9) | 12 (1.7) | 10 (2.6) |
| Fungal infections | 11 (1.0) | 6 (0.9) | 5 (1.3) |
| Vestibular disorders | 9 (0.8) | 6 (0.9) | 4 (1.0) |
| Blood urea increased | 1 (0.1) | 0 | 0 |
| Esophageal disorders | 1 (0.1) | 0 | 0 |
| Pancreatitis | 1 (0.1) | 0 | 1 (0.3) |
| TEAE . | Omadacycline (n = 1073) . | Linezolid (n = 689) . | Moxifloxacin (n = 388) . |
|---|---|---|---|
| Hypersensitivity reactions | 20 (1.9) | 12 (1.7) | 10 (2.6) |
| Fungal infections | 11 (1.0) | 6 (0.9) | 5 (1.3) |
| Vestibular disorders | 9 (0.8) | 6 (0.9) | 4 (1.0) |
| Blood urea increased | 1 (0.1) | 0 | 0 |
| Esophageal disorders | 1 (0.1) | 0 | 0 |
| Pancreatitis | 1 (0.1) | 0 | 1 (0.3) |
Data are presented as No. (%). A TEAE was defined as an adverse event with a start date/time on or after the date/time of the first dose of active study drug. If a patient had >1 TEAE with the same category, the patient was counted only once for that category.
Abbreviations: OASIS, Omadacycline in Acute Skin and Skin Structure Infections Study; OPTIC, Omadacycline for Pneumonia Treatment In the Community; TEAE, treatment-emergent adverse event.
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