TABLE 1

Disposition of subjects by treatment group in the randomized population

Groupn (%) in treatment groupa
250 mg REL + IMI125 mg REL + IMIPlacebo + IMITotal
Randomizedb118116117351
Treated with any study therapy117 (99.2)114 (98.3)116 (99.1)347 (98.9)
Completed study medication112 (94.9)107 (92.2)111 (94.9)330 (94.0)
Discontinued study medication because of:5 (4.2)7 (6.0)5 (4.3)17 (4.8)
    Adverse event1 (0.8)4 (3.4)3 (2.6)8 (2.3)
    Death0 (0.0)1 (0.9)0 (0.0)1 (0.3)
    Lack of efficacy0 (0.0)0 (0.0)1 (0.9)1 (0.3)
    Lost to follow-up0 (0.0)0 (0.0)1 (0.9)1 (0.3)
    Physician decision0 (0.0)2 (1.7)0 (0.0)2 (0.6)
    Protocol violation2 (1.7)0 (0.0)0 (0.0)2 (0.6)
    Insufficient drug supply1 (0.8)0 (0.0)0 (0.0)1 (0.3)
    Withdrawal by subject1 (0.8)0 (0.0)0 (0.0)1 (0.3)
Completed study114 (96.6)109 (94.0)114 (97.4)337 (96.0)
Discontinued from study because of:4 (3.4)7 (6.0)3 (2.6)14 (4.0)
    Adverse event0 (0.0)2 (1.7)0 (0.0)2 (0.6)
    Death0 (0.0)1 (0.9)0 (0.0)1 (0.3)
    Lost to follow-up0 (0.0)1 (0.9)2 (1.7)3 (0.9)
    Progressive disease0 (0.0)1 (0.9)0 (0.0)1 (0.3)
    Protocol violation3 (2.5)1 (0.9)0 (0.0)4 (1.1)
    Insufficient drug supply1 (0.8)0 (0.0)0 (0.0)1 (0.3)
    Withdrawal by subject0 (0.0)1 (0.9)1 (0.9)2 (0.6)
  • a REL, relebactam; IMI, 500 mg imipenem-cilastatin.

  • b Percentages are based on the number of subjects randomized as the denominator.