ABSSSI and CABP Pooled Adverse Reactions From Phase 3 Clinical Trials1 | ||
Adverse Reaction |
TEFLARO (N=1300) |
Pooled Comparators* (N=1297) |
Gastrointestinal disorders | ||
Diarrhea | 5% | 3% |
Nausea | 4% | 4% |
Constipation | 2% | 2% |
Vomiting | 2% | 2% |
Investigations | ||
Increased transaminases | 2% | 3% |
Metabolism and nutrition disorders |
||
Hypokalemia | 2% | 3% |
Skin and subcutaneous tissue disorders |
||
Rash | 3% | 2% |
Vascular disorders | ||
Phlebitis | 2% | 1% |
ABSSSI and CABP Pooled Adverse Reactions From Phase 3 Clinical Trials1 | |
TEFLARO (N=1300) |
Pooled Comparators* (N=1297) |
Adverse Reaction | |
Gastrointestinal disorders | |
Diarrhea | |
5% | 3% |
Nausea | |
4% | 4% |
Constipation | |
2% | 2% |
Vomiting | |
2% | 2% |
Investigations | |
Increased transaminases | |
2% | 3% |
Metabolism and nutrition disorders |
|
Hypokalemia | |
2% | 3% |
Skin and subcutaneous tissue disorders |
|
Rash | |
3% | 2% |
Vascular disorders | |
Phlebitis | |
2% | 1% |
Comparators included vancomycin 1 g IV every 12h plus aztreonam 1 g IV every 12h in the Phase 3 ABSSSI trials, and ceftriaxone 1 g IV every 24h in the Phase 3 CABP trials.
Please also see full Prescribing Information.
Please also see full Prescribing Information.