Registered outcomes11

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

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS)	Up to 5 years	Defined as the time from randomization date to the first documented PD (Progression of Disease), as assessed by BICR according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) or death due to any cause, whichever occurs first.
Secondary	Time-To-Treatment Failure (TTF)	Up to 13 years	Defined as the time from randomization date to the discontinuation of study drug during the treatment period due to death, treatment-related adverse event, or PD, as assessed by BICR according to RECIST v1.1, whichever occurs first.
Secondary	Objective Response Rate (ORR)	Up to 13 years	Defined as the proportion of participants who achieve a CR (Complete Response) or a PR (Partial Response) prior to progressive disease and/or other anti-cancer therapy, as assessed by BICR according to RECIST v1.1.
Secondary	Overall Survival (OS)	Up to 13 years	Defined as the time from randomization date to death due to any cause.
Secondary	Percentage of Participants With Adverse Events (AEs)	Up to 13 years	Incidence and severity determined according to the NCI CTCAE v5.0 (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0) criteria.
Secondary	Duration of Response (DOR)	Up to 13 years	Defined as the number of weeks from the time criteria are first met for either a CR or a PR, until the date of documented PD, as assessed by BICR according to RECIST v1.1, or death due to any cause, whichever occurs first.
Secondary	Disease Control Rate (DCR)	Up to 13 years	Defined as the proportion of participants who experience a best response of CR, PR, or stable disease, as assessed by BICR according to RECIST v1.1.
Secondary	Clinical Benefit Rate (CBR)	Up to 13 years	Defined as the proportion of participants who experience a CR or a PR or a best response of stable disease with a minimum duration of 6 months, as assessed by BICR according to RECIST v1.1.
Secondary	Time to Deterioration of Function	Up to 13 years	Defined as the time from randomization to the date of a participant's first \>= 10-point decrease from baseline score, as assessed through the use of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Secondary	Quality of Life (QoL)	Up to 13 years	Defined as the time from randomization to the date of a participant's first \>= 10-point decrease from baseline score, as assessed through the use of the GHS (Global Health Status)/QoL scales.
Secondary	Acceptability and Palatability of Pralsetinib Capsules	Up to 13 years	Acceptability Survey scores on Day 1 of Cycle 1 and Crossover Cycle 1 (each cycle is 28 days).

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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