TABLE 5

Ranolazine- or best standard therapy (BST)-related adverse events (AEs) from T1 to T5

Patients with AEsAEAE IntensityAE SeriousnessAE ManagementDiastolic Dysfunction Event at T1Event Outcome at T5
Ranolazie arm (n = 4)ConstipationModerateNot seriousNoneBNP > ULNNormalized
ConstipationSevereNot seriousNoneBNP > ULNNormalized
NauseaMild-mildNot seriousNoneImpaired relaxationNormalized
Constipation-tinnitusSevere-moderateNot seriousDose reductionacTnI > ULNNormalized
BST arm (n = 1)AstheniaSevereNot seriousDose reductionbBNP > ULNImproved
  • AE, adverse event; BNP, B-type natriuretic peptide; BST, best standard therapy; cTnI, cardiac troponin isoform I; T1, 1 week after chemotherapy; T5, 5 weeks after randomization; ULN, upper limit of normal.

  • a From 500 to 375 mg twice daily.

  • b Ramipril reduced from 2.5 to 1.25 mg/day.