Most Frequent Treatment-emergent Adverse Events (≥3% Incidence for Any Drug), by Treatment Group and Preferred Term
| Parameter . | Omadacycline (n = 691), n (%) . | Linezolid (n = 689), n (%) . |
|---|---|---|
| Patients with ≥1 TEAE | 353 (51.1) | 284 (41.2) |
| Nausea | 151 (21.9) | 60 (8.7) |
| Vomiting | 79 (11.4) | 27 (3.9) |
| Wound infection | 30 (4.3) | 22 (3.2) |
| ALT increased | 28 (4.1) | 25 (3.6) |
| Infusion-site extravasation | 28 (4.1) | 19 (2.8) |
| Cellulitis/erysipelas | 27 (3.9) | 24 (3.5) |
| AST increased | 25 (3.6) | 24 (3.5) |
| Headache | 23 (3.3) | 21 (3.0) |
| Subcutaneous abscess | 23 (3.3) | 27 (3.9) |
| Diarrheaa | 22 (3.2) | 20 (2.9) |
| Parameter . | Omadacycline (n = 691), n (%) . | Linezolid (n = 689), n (%) . |
|---|---|---|
| Patients with ≥1 TEAE | 353 (51.1) | 284 (41.2) |
| Nausea | 151 (21.9) | 60 (8.7) |
| Vomiting | 79 (11.4) | 27 (3.9) |
| Wound infection | 30 (4.3) | 22 (3.2) |
| ALT increased | 28 (4.1) | 25 (3.6) |
| Infusion-site extravasation | 28 (4.1) | 19 (2.8) |
| Cellulitis/erysipelas | 27 (3.9) | 24 (3.5) |
| AST increased | 25 (3.6) | 24 (3.5) |
| Headache | 23 (3.3) | 21 (3.0) |
| Subcutaneous abscess | 23 (3.3) | 27 (3.9) |
| Diarrheaa | 22 (3.2) | 20 (2.9) |
Data are from the safety population. Percentages were based on the number of patients in each treatment group. Patients may have been counted in >1 row. Coding of preferred terms was based on the Medical Dictionary for Regulatory Activities, Version 17.1.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; TEAE, treatment-emergent adverse event.
aThere were no cases of infection with Clostridioides difficile in either study.
Most Frequent Treatment-emergent Adverse Events (≥3% Incidence for Any Drug), by Treatment Group and Preferred Term
| Parameter . | Omadacycline (n = 691), n (%) . | Linezolid (n = 689), n (%) . |
|---|---|---|
| Patients with ≥1 TEAE | 353 (51.1) | 284 (41.2) |
| Nausea | 151 (21.9) | 60 (8.7) |
| Vomiting | 79 (11.4) | 27 (3.9) |
| Wound infection | 30 (4.3) | 22 (3.2) |
| ALT increased | 28 (4.1) | 25 (3.6) |
| Infusion-site extravasation | 28 (4.1) | 19 (2.8) |
| Cellulitis/erysipelas | 27 (3.9) | 24 (3.5) |
| AST increased | 25 (3.6) | 24 (3.5) |
| Headache | 23 (3.3) | 21 (3.0) |
| Subcutaneous abscess | 23 (3.3) | 27 (3.9) |
| Diarrheaa | 22 (3.2) | 20 (2.9) |
| Parameter . | Omadacycline (n = 691), n (%) . | Linezolid (n = 689), n (%) . |
|---|---|---|
| Patients with ≥1 TEAE | 353 (51.1) | 284 (41.2) |
| Nausea | 151 (21.9) | 60 (8.7) |
| Vomiting | 79 (11.4) | 27 (3.9) |
| Wound infection | 30 (4.3) | 22 (3.2) |
| ALT increased | 28 (4.1) | 25 (3.6) |
| Infusion-site extravasation | 28 (4.1) | 19 (2.8) |
| Cellulitis/erysipelas | 27 (3.9) | 24 (3.5) |
| AST increased | 25 (3.6) | 24 (3.5) |
| Headache | 23 (3.3) | 21 (3.0) |
| Subcutaneous abscess | 23 (3.3) | 27 (3.9) |
| Diarrheaa | 22 (3.2) | 20 (2.9) |
Data are from the safety population. Percentages were based on the number of patients in each treatment group. Patients may have been counted in >1 row. Coding of preferred terms was based on the Medical Dictionary for Regulatory Activities, Version 17.1.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; TEAE, treatment-emergent adverse event.
aThere were no cases of infection with Clostridioides difficile in either study.
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