Table 4.

Summary of adverse events in safety analysis population

AEsaJTT-751 (n=60)Placebo (n=30)
PatientsPercentPatientsPercent
Any AE4168.31810.0
Any serious AEb813.3310.0
Any adverse drug reaction1931.7826.7
Adverse drug reactionsc
 Diarrhea813.326.7
 Constipation711.726.7
 Abdominal discomfort35.0310.0
 Abdominal distension35.00
 Duodenal ulcer23.30
 Nausea11.726.7
  • AE, adverse event.

  • a Medical Dictionary for Regulatory Activities version 13.1 preferred terms.

  • b Except death (one patient in the JTT-751 group), nine serious AEs (duodenal ulcer, azotemia, congestive cardiac failure, shunt stenosis, gouty arthritis, nephrogenic anemia, cellulitis, chronic renal failure, and bronchopneumonia) occurred in the JTT-751 group and four serious AEs (bacterial gastroenteritis, contusion, chronic GN, and mycoplasma infection) occurred in the placebo group.

  • c Adverse drug reactions occurring in two or more patients in either treatment group are listed.