Table 9.

Recommended minimum reporting criteria for phase 3 clinical trials

Reporting objectiveReporting end point
Response rate• CR/CRi achieved at completion of induction cycle 1 (%)
• CR/CRi rate after completion of all induction cycles (%)
Treatment failure• Primary refractory disease (%) as indicated by failure to achieve CR/CRi after completing induction therapy (2 cycles)
• % Death from any cause within 30 d
• % Death from any cause within 60 d
RFS• Median RFS from date of CR to relapse (mo)
• 1-y/3-y/5-y RFS (%)
EFS• Median EFS (mo)
• 1-y/3-y/5-y EFS (%)
OS*• Median OS (mo)
• 1-y/3-y/5-y OS (%)
Time to neutrophil recovery• No. of days from day 1 of commencing induction therapy to first day neutrophils 0.5 × 109/L
• No. of days from day 1 of commencing induction therapy to first day neutrophils 1.0 × 109/L
Time to platelet recovery• No. of days from day 1 of commencing induction therapy to first day platelets 50 × 109/L
• No. of days from day 1 of commencing induction therapy to first day platelets 100 × 109/L
  • * OS should also be reported with patients censored on day 0 of allogeneic HCT.