Trial · NCT03430843
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set | Approximately 2 years and 10 months from date of first randomization | The ITT analysis set included all randomized participants | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the PDL-1 Positive Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The PD-L1 positive population included all randomized participants with tumor PD-L1 vCPS ≥10% | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The ITT analysis set included all randomized participants | Percentage of Participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10% | Percentage of Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The ITT analysis set included all randomized participants | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10% | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The ITT analysis set included all randomized participants; only participants with an objective response (CR or PR) were included in this analysis | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) in the PDL-1 Positive Analysis Set. | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; only participants with an objective response (CR or PR) were included in this analysis | Months | MEDIAN |
| SECONDARY | Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set | Baseline to Cycle 6 (21 days per cycle) | The ITT analysis set included all randomized participants; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point. | Score on a scale | MEAN |
| SECONDARY | HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set | Baseline to Cycle 6 (21 days per cycle) | The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point. | Score on a scale | MEAN |
| SECONDARY | HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set | Baseline to Cycle 6 (21 days per cycle) | The ITT analysis set included all randomized participants; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point. | Score on a scale | MEAN |
| SECONDARY | HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set. | Baseline to Cycle 6 (21 days per cycle) | The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point. | Score on a scale | MEAN |
| SECONDARY | HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set | Baseline to Cycle 6 (21 days per cycle) | The ITT analysis set included all randomized participants; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point. | Score on a scale | MEAN |
| SECONDARY | HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set | Baseline to Cycle 6 (21 days per cycle) | The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point | Score on a scale | MEAN |
| SECONDARY | Number of Participants Experiencing Adverse Events (AEs) | From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months | Safety analysis set included all participants who received ≥ 1 dose of study drug | Participants | NUMBER |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03430843/outcomes