End point characteristics and level of evidence regarding efficacy
End point . | Definition . | Nature . | Centeredness . | Level of evidence regarding efficacy . | Safety outcomes . |
---|---|---|---|---|---|
OS | Time from study entry to death of any cause | Censored | Patient | Level 1 | Nonrelapse toxicity |
QOL | Subjective perception of health-related well-being | Continuous, repetitive measurements | Patient | Level 1 but conditionally to survival | Symptoms associated with (serious) AEs |
TTNT | Time from study entry to initiation of new curative therapy or death | Censored | Patient | Level 4 in cutaneous lymphoma | Tolerability |
PFS | Time from study entry to progression or death | Censored | Tumor | Level 1 in FL/MZL Level 2 in DLBCL Level 3 otherwise | — |
POD24 | Progression between study entry and 2 years | Binary | Tumor | Level 4 in FL/MZL/MCL | — |
Overall/complete response (including MRD) | Best response assessment | Binary | Tumor or cell (MRD) | Level 3 | — |
Response assessment at a precise time point | Binary | Tumor or cell (MRD) | Level 2 in MZL (CR24) and FL (CR30) | — | |
EFS | Time from study entry to a prespecified composite event | Censored | Composite | Level 3 in R/R DLBCL and AML | Study dependent |
End point . | Definition . | Nature . | Centeredness . | Level of evidence regarding efficacy . | Safety outcomes . |
---|---|---|---|---|---|
OS | Time from study entry to death of any cause | Censored | Patient | Level 1 | Nonrelapse toxicity |
QOL | Subjective perception of health-related well-being | Continuous, repetitive measurements | Patient | Level 1 but conditionally to survival | Symptoms associated with (serious) AEs |
TTNT | Time from study entry to initiation of new curative therapy or death | Censored | Patient | Level 4 in cutaneous lymphoma | Tolerability |
PFS | Time from study entry to progression or death | Censored | Tumor | Level 1 in FL/MZL Level 2 in DLBCL Level 3 otherwise | — |
POD24 | Progression between study entry and 2 years | Binary | Tumor | Level 4 in FL/MZL/MCL | — |
Overall/complete response (including MRD) | Best response assessment | Binary | Tumor or cell (MRD) | Level 3 | — |
Response assessment at a precise time point | Binary | Tumor or cell (MRD) | Level 2 in MZL (CR24) and FL (CR30) | — | |
EFS | Time from study entry to a prespecified composite event | Censored | Composite | Level 3 in R/R DLBCL and AML | Study dependent |