Trial · NCT02564263
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in All Participants | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing an Adverse Event (AE) | Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) | The analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were included in the treatment group to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE) | Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) | The analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were included in the treatment group to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
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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