Table 1.

End point characteristics and level of evidence regarding efficacy

End pointDefinitionNatureCenterednessLevel of evidence regarding efficacySafety 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 pointDefinitionNatureCenterednessLevel of evidence regarding efficacySafety 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 
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