Table 2.
Number of Participants with Grade 2 or Higher Adverse Events, by Arm
| Adverse Event | Mero 2 g TID + Amx/Clv + Rifampin (Arm C) (n = 17) | Mero 2 g TID + Amx/Clv (Arm D) (n = 15) | Mero 1 g TID + Amx/Clv (Arm E) (n = 14) | Mero 3 g QD + Amx/Clv (Arm F) (n = 14) |
|---|---|---|---|---|
| Gastrointestinal and hepatobiliary, n (%) | ||||
| Loose stool | 1 (5.8) | 0 | 0 | 0 |
| Nausea | 2 (11.8) | 1 (6.7) | 0 | 0 |
| Vomiting | 0 | 1 (6.7) | 0 | 0 |
| Elevated ALT or AST or both | 0 | 1 (6.7) | 0 | 1 (7.1) |
| Skin, n (%) | ||||
| Cellulitis | 1 (5.8) | 0 | 0 | 0 |
| Dermatitis of the scrotum | 0 | 1 (6.7) | 0 | 0 |
| Superficial thrombophlebitis | 0 | 0 | 0 | 1 (7.1) |
| Musculoskeletal, n (%) | ||||
| Lower back pain | 0 | 1 (6.7) | 0 | 1 (7.1) |
| Calf pain | 0 | 0 | 1 (7.1) | 0 |
| Hematological, n (%) | ||||
| Anemia | 0 | 0 | 0 | 1 (7.1) |
| Other, n (%) | ||||
| Pharyngitis | 0 | 1 (6.7) | 0 | 0 |
| Night sweats | 0 | 0 | 1 (7.1) | 0 |
| Tachycardia | 0 | 0 | 1 (7.1) | 0 |
| Headache | 1 (5.8) | 0 | 0 | 1 (7.1) |
| Sore throat | 0 | 1 (6.7) | 0 | 0 |
Definition of abbreviations: ALT = alanine aminotransferase; Amx/Clv = amoxicillin/clavulanate; AST = aspartate aminotransferase; Mero = meropenem; QD = once daily; TID = every 8 hours. For arms C–E: Amx/Clv was given at a dose of 500 mg/125 mg TID. For arm F: Amx/Clv was given at a dose of 875 mg/125 mg QD.