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. 2018 Jan 25;62(2):e01487-17. doi: 10.1128/AAC.01487-17

TABLE 5.

Summary of treatment-emergent adverse eventsa

Parameter Value(s) for:
Omadacycline dose
Omadacycline overall (n = 26) Placebo overall (n = 7)
300 mg (n = 26) 450 mg (n = 24) 600 mg (n = 24)
No. (%) with any TEAE 5 (19.2) 3 (12.5) 6 (25.0) 10 (38.5) 2 (28.6)
No. (%) with treatment-related TEAE 4 (15.4) 2 (8.3) 6 (25.0) 9 (34.6) 1 (14.3)
Most frequent TEAEs (seen in >1 study subject), n (%)
    Nausea 2 (7.7) 1 (4.2) 4 (16.7) 6 (23.1) 0
    Vomiting 2 (7.7) 0 1 (4.2) 3 (11.5) 0
    Diarrhea 0 0 2 (8.3) 2 (7.7) 0
    Dizziness 2 (7.7) 0 1 (4.2) 3 (11.5) 0
    ALT increased 0 1 (4.2) 1 (4.2) 2 (7.7) 0
TEAEs leading to early discontinuation of study drug, n (%)
    All 1 (3.8) 1 (4.2) 1 (4.2) 3 (11.5) 1 (14.3)
    Nausea 1 (3.8) 0 0 1 (3.8) 0
    Vomiting 1 (3.8) 0 0 1 (3.8) 0
    ALT increased 0 1 (4.2) 0 1 (3.8) 0
    Lipase increased 0 0 1 (4.2) 1 (3.8) 0
    Syncope 0 0 0 0 1b (14.3)
a

Results for safety population.

b

Vasovagal syncope following a blood draw.