Klinische Studien Radar

Progression-free survival

Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

Baseline up to data cut-off (up to approximately 2 years)

complete response rate

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Overall response rate

Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria

End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Overall survival

Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.

Baseline up to data cut-off (up to approximately 4 years)

Duration of response

Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.

Baseline up to data cut-off (up to approximately 4 years)

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Baseline up to data cut-off (up to approximately 4 years)

Tumor tissue gene mutations analysis

Targeted sequencing was used to detect 84 genes which can classify PTCL patients into different molecular subtypes.

Baseline up to data cut-off (up to approximately 4 years)

Circulating free Deoxyribonucleic Acid (cfDNA) monitoring

CfDNA in peripheral blood assessed by local lab

Baseline up to data cut-off (up to approximately 4 years)