TABLE 8.

Adverse events with a suspected or probable relationship to study medication reported by ≥1% of patients

Population or adverse eventaNo. (%) of patients in amoxicillin-clavulanate group:
2,000/125 mg (n = 322)875/125 mg (n = 311)
Patients with at ≥1 adverse event61 (18.9)57 (18.3)
Diarrhea36 (11.2)29 (9.3)
Nausea8 (2.5)8 (2.6)
SGPT (ALT) increased7 (2.2)1 (0.3)
SGOT (AST) increased5 (1.6)1 (0.3)
Vomiting5 (1.6)3 (1.0)
Genital moniliasis4 (1.2)2 (0.6)
Abdominal pain2 (0.6)7 (2.3)
  • a SGPT, serum glutamic pyruvic transaminase; ALT, alanine aminotransferase; SGOT, serum glutamic oxaloacetic transaminase; AST, aspartate aminotransferase.