Trial · NCT04236141
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Response (CR) at the End of Treatment (EOT) Assessment Based on Positron Emission Tomography-Computed Tomography (PET-CT) Assessed by Independent Review Committee (IRC) | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at the EOT Assessment Based on PET-CT as Assessed by Investigator | Up to approximately to 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (OR) at EOT Based on PET-CT as Assessed by Investigator | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR at EOT Based on PET-CT as Assessed by IRC | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at EOT Based on Computed Tomography (CT) as Assessed by Investigator | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at EOT Based on CT as Assessed by IRC | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by Investigator | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by IRC | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by Investigator | Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks) | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by IRC | Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks) | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Duration Of Response (DOR) Based on PET-CT/CT Only as Assessed by Investigator | Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks) | ITT population included all participants randomized, whether or not the participants received the assigned treatment. Overall number of participants analyzed are the number of BOR responders as assessed by investigator. | months | MEDIAN |
| SECONDARY | DOR Based on PET-CT/CT Only as Assessed by IRC | Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks) | ITT population included all participants randomized, whether or not the participants received the assigned treatment. Overall number of participants analyzed are the number of BOR responders assessed by IRC. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Based on PET-CT/CT Only as Assessed by Investigator | Up to approximately 82 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | months | MEDIAN |
| SECONDARY | PFS Based on PET-CT/CT Only as Assessed by IRC | Up to approximately 82 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | months | MEDIAN |
| SECONDARY | Event-Free Survival (EFS) Based on PET-CT or CT Assessed by Investigator | Up to approximately 82 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 82 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | Up to approximately 82 weeks | Safety population included all randomized participants who received at least one dose of the study drug. | percentage of participants | NUMBER |
| SECONDARY | Serum Concentration of Total Antibody at Specified Timepoints | Predose & post dose on Day 2 of Cycle 1,& post dose on Days 8 & 15 of Cycles 1& 3; predose & post dose on Day 1 of Cycles 2, 3 & 4; treatment completion/early discontinuation visit; follow-up visits at Months 3 &6 (1 cycle=21 days) up to approx. 46 weeks | PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Number analyzed is the number of participants with data available for analysis at the specified time point. | micrograms per milliliter (μg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Plasma Concentration of Antibody-Conjugated Monomethyl Auristatin E (acMMAE) at Specified Timepoints | Predose and post dose on Day 2 of Cycle 1, and post dose on Days 8 and 15 of Cycles 1 and 3; predose and post dose on Day 1 of Cycles 2, 3 and 4; treatment completion/early discontinuation visit (each cycle = 21 days) up to approximately 19 weeks | PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Number analyzed is the number of participants with data available for analysis at the specified time point. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Plasma Concentration of Unconjugated Monomethyl Auristatin E (MMAE) at Specified Timepoints | Predose and post dose on Day 2 of Cycle 1, and post dose on Days 8 and 15 of Cycles 1 and 3; predose and post dose on Day 1 of Cycles 2, 3 and 4; treatment completion/early discontinuation visit (each cycle = 21 days) up to approximately 19 weeks | PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Number analyzed is the number of participants with data available for analysis at the specified time point. | ng/mL | GEOMETRIC_MEAN |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04236141/outcomes