Trial · NCT04865289
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants | Up to approximately 45 months | All pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized. | Months | MEDIAN |
| PRIMARY | PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants | Up to approximately 45 months | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in pMMR Participants | Up to approximately 45 months | All pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized. | Months | MEDIAN |
| PRIMARY | OS in All Randomized Participants | Up to approximately 45 months | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants | Up to approximately 45 months | Per the statistical analysis plan, all pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion with measurable disease at the baseline scan were analyzed according to the treatment arm to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants | Up to approximately 45 months | Per the statistical analysis plan, all Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion with measurable disease at the baseline scan were analyzed according to the treatment arm to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score in pMMR Participants | Baseline and up to approximately 18 weeks | All pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion who had at least one assessment available for EORTC QLQ-C30 and received at least one dose of the study intervention were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Score in All Randomized Participants | Baseline and up to approximately 18 weeks | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion who had at least one assessment available for EORTC QLQ-C30 and received at least one dose of the study intervention were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Experiencing an Adverse Event (AE) | From first dose date to 120 days after last dose date (up to approximately 58 months) | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion and received at least one dose of the study intervention were analyzed | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing a Serious Adverse Event (SAE) | From first dose date to 120 days after last dose date (up to approximately 58 months) | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion and received at least one dose of the study intervention were analyzed | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing an Immune-related AE (irAE) | From first dose date to 120 days after last dose date (up to approximately 58 months) | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion and received at least one dose of the study intervention were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Discontinuing From Study Treatment Due to an AE(s) | From first dose date to last dose date (up to approximately 54 months) | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion and received at least one dose of the study intervention were analyzed | 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.
For software
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