Table 9.
Recommended minimum reporting criteria for phase 3 clinical trials
| Reporting objective | Reporting 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.