Trial · NCT04223856
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 | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR) | From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months) | ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months) | ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response Rate (ORR) Per RECIST v1.1 by BICR | From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years) | |||
| SECONDARY | Time to Pain Progression (TTPP) | From the date of randomization to date of pain progression (maximum up to approximately 7.4 years) | |||
| SECONDARY | Change From Baseline in Worst Pain Using BPI-SF at Week 26 | Baseline, Week 26 | |||
| SECONDARY | PFS Per RECIST v1.1 by Investigator Assessment | From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 7.4 years) | |||
| SECONDARY | ORR Per RECIST v1.1 by Investigator Assessment | From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years) | |||
| SECONDARY | Duration of Response (DOR) Per RECIST v1.1 by BICR | From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years) | |||
| SECONDARY | DOR Per RECIST v1.1 by Investigator Assessment | From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years) | |||
| SECONDARY | Disease Control Rate (DCR) Per RECIST v1.1 by BICR | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years) | |||
| SECONDARY | DCR Per RECIST v1.1 by Investigator Assessment | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years) | |||
| SECONDARY | Mean Scores in Patient Reported Outcome (PRO) Assessment Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) | End of study (approximately up to 7.4 years) | |||
| SECONDARY | Change From Baseline in PRO Assessment Measured by the EQ-5D-5L | Baseline, End of study (approximately up to 7.4 years) | |||
| SECONDARY | Mean Scores in PRO Assessment Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) | End of study (approximately up to 7.4 years) | |||
| SECONDARY | Change From Baseline in PRO Assessment Measured by EORTC QLQ-C30 | Baseline, End of study (approximately up to 7.4 years) | |||
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events Adverse Events (AEs) | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) | |||
| SECONDARY | Number of Participants With Serious TEAE | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) | |||
| SECONDARY | Number of Participants With Grade 3-5 TEAE | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) | |||
| SECONDARY | Number of Participants Related to Treatment AEs | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) | |||
| SECONDARY | Number of Participants With Laboratory Abnormalities | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) |
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/NCT04223856/outcomes