Trial · NCT03947255
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | Up to 18.3 months | Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR |
| Primary | Number of Participants With Adverse Events | Up to 36 months | An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. |
| Primary | Number of Participants With Laboratory Abnormalities | Up to 36 months | Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter. |
| Secondary | Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria | Up to 17.1 months | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. |
| Secondary | Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria | up to 18.3 months | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. |
| Secondary | Overall Survival (OS) | Up to 35.8 months | OS is defined as the time from date of enrollment to date of death due to any cause. |
| Secondary | Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria | Up to 18.3 months | CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) |
| Secondary | ORR Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 18.3 months | Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment |
| Secondary | DOR Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 17.1 months | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. |
| Secondary | Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 18.3 months | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. |
| Secondary | Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 18.3 months | CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014). |
| Secondary | ORR Per BICR According to Lugano Response Criteria | Up to 18.3 months | ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014) |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT03947255/registered