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8-K
PARATEK PHARMACEUTICALS, INC. filed this Form 8-K on 01/04/2019
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Slide 39

Selected TEAS Occurring in ≥2% of Patients Receiving Omadacycline in the Pooled Phase 3 CABP and ABSSSI Clinical Trials Omadacycline (N = 1073) Linezolid (N = 689) Moxifloxacin (N = 388) Nausea1 14.9 8.7 5.4 Vomiting1 8.3 3.9 1.5 Diarrhea2 2.4 2.9 8.0 Transaminase Elevations Increased 4.3 4.4 5.2 Headache 2.9 3.0 1.3 Events of Nausea and Vomiting in Phase 3 CABP and ABSSSI Clinical Trials CABP IV/Oral ABSSSI IV/Oral ABSSSI Oral-Only IV Oral IV Oral Oral (D1 thru D2) Oral (D3 thru EOT) Nausea1 0.5 2.4 4.3 9.1 25.2 4.1 Vomiting 1.8 1.0 1.2 4.5 12.5 4.1 Most Frequent TEAEs in the OASIS-1, OASIS-2 and OPTIC Studies Omadacycline Safety and Tolerability Profile Established 1 Nearly all events of nausea and vomiting were mild or moderate in severity, resolved, and were not treatment limiting. Only 4 patients (0.4%) discontinued OMC treatment for nausea or vomiting. 2 Diarrhea occurred in 2.4% of OMC patients and no cases of C. difficile infection were reported in OMC patients