Table 2.

Treatment administered (n = 15 patients)

Amendment after sudden death on the study
Patient no.Treatment on original protocol
Treatment on amended protocol
Course I
Course II
Course I
Course II
Course III
D1D8D15D1D8D15D1D8D15D1D8D15D1D8D15
001××××××Patient withdrawal due to new risks in the consent—off study
002××Study on holdPatient withdrawal due to new risks in the consent—off study
003×Study on holdD/C
004×××Study on hold××D/C
005××××PD–off studyPD–off study
006×××××Sudden deathSudden death–off study
007×××Study on holdPatient withdrawal due to new risks in the consent—off study
008×Study on holdPatient withdrawal due to new risks in the consent—off study
009××Study on holdPatient withdrawal due to new risks in the consent—off study
010×Study on hold××PD—off study
011×Study on hold×D/C
012Not accrued at this point××××××PD—off study
013Not accrued at this point×Ventricular tachycardia—off study
014Not accrued at this point×Ventricular tachycardia—off study
015Not accrued at this point×D/C
  • NOTE: ×, 14 mg/m2/dose of depsipeptide; ▴, 10 mg/m2/dose of depsipeptide.

    Abbreviations: PD, progressive disease; D/C, discontinued due to study termination.