TABLE 7

Incidence of AEs occurring with TBPM-PI-HBr in SAD and MAD phases

AE(s)No. (%) of subjects [no. of events]
SAD phaseMAD phase
TBPM-PI-HBrOrapenemPlaceboTBPM-PI-HBrPlacebo
All SAD
(n = 75)
300 mg
(n = 8)
(n = 25)300 mg
(n = 6)
600 mg
(n = 6)
(n = 4)
Treatment-emergent AEs20 (27) [33]5 (63) [10]10 (40) [15]6 (100) [12]6 (100) [16]4 (100) [6]
Treatment-related AEs11 (15) [14]3 (38) [5]3 (12) [5]6 (100) [9]5 (83) [11]2 (50) [4]
Abdominal discomfort001 (4) [1]1 (17) [1]00
Abdominal distention000001 (25) [1]
Abdominal pain0001 (17) [1]1 (17) [1]1 (25) [1]
Abdominal pain, upper00002 (33) [2]1 (25) [1]
Alanine aminotransferase increase01 (13) [1]1 (4) [1]2 (33) [2]1 (17) [1]0
Aspartate aminotransferase increase01 (13) [1]1 (4) [1]1 (17) [1]00
Diarrhea6 (8) [6]01 (4) [1]2 (33) [2]5 (83) [5]1 (25) [1]
Dizziness1 (1) [1]00000
Dry mouth1 (1) [1]001 (17) [1]00
Gamma glutamyl transferase increase001 (4) [1]01 (17) [1]1 (25) [1]
Abnormal gastrointestinal sounds1 (1) [1]00000
Headache3 (4) [5]2 (25) [3]01 (17) [1]1 (17) [1]0