Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Progression-free survival (PFS)	Baseline up to 5 years	The time from randomization to disease progression or death from any cause, whichever occurs first.
Secondary	Investigator-assessed PFS	Baseline up to 5 years	The time from randomization to disease progression or death from any cause, whichever comes first.
Secondary	PFS rates at 6, 12 and 18 months	From baseline to 18 months	The proportion of patients who remain free from disease progression or death at 6, 12 and 18 months after randomization.
Secondary	Overall response rate (ORR)	Baseline up to 5 years	The proportion of patients with a complete response (CR) or partial response (PR) after treatment.
Secondary	Very Good Partial Response (VGPR)	Baseline up to 5 years	The best overall response is defined as the sum proportion of subjects achieving stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). or very good partial response (VGPR).
Secondary	Complete Response (CR) Rate	Baseline up to 5 years	The percentage of evaluable subjects who achieve complete response (CR).
Secondary	Duration of remission (DOR)	Baseline up to 5 years	The time from the first onset of objective response to the first documentation of disease progression or death from any cause, whichever occurs first.
Secondary	Time to first remission (TTR)	Baseline up to 5 years	The time from randomization to the first achievement of objective response.
Secondary	Negative rate of minimal residual disease (MRD)	Baseline up to 5 years	The proportion of subjects achieving MRD negativity.
Secondary	Overall survival (OS)	From randomization to death, the estimated evaluation period is up to 5 years	Time from randomization to death.
Secondary	Adverse event rate	From randomization to 2 months after the last dose	The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Secondary	Peak concentration (Cmax)	Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, after dose of Cycle 2 Day 1, Cycle 6 Day 1，Last visit (up to 5 years), each cycle is 28 days.	Maximum plasma drug concentration.
Secondary	Anti-drug antibody (ADA) positive rate	Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, Last visit (up to 5 years) and 30 days after the last administration each, each cycle is 28 days.	The proportion of evaluable subjects with positive test results for anti-drug antibody (ADA).
Secondary	Nab positive rate	Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, Last visit (up to 5 years) and 30 days after the last administration each, each cycle is 28 days.	The percentage of evaluable subjects with positive neutralizing antibody (NAB) test results in all evaluable subjects.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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