Trial · NCT03430843
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set | Approximately 2 years and 10 months from date of first randomization | OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants |
| 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) | OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%. |
| 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) | ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; |
| 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) | ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1; |
| 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) | PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set |
| 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) | PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set |
| 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) | DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first |
| 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) | DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first |
| 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) | Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes |
| Secondary | HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes |
| 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) | Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. |
| Secondary | HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set. | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. |
| 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) | Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. |
| Secondary | HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. |
| 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 | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs |
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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