Trial · NCT03138512
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-Free Survival (DFS) by BICR - Treatment Part A and B | From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months) | All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms) and Treatment Part B (Placebo and Nivo Arms). The Nivo + Ipi Arm was prespecified to be excluded from the endpoint objective for Treatment Part B. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) - Treatment Part A and B | From randomization to the date of death (up to approximately 72 months) | All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms) and Treatment Part B (Placebo and Nivo Arms). The Nivo + Ipi Arm was prespecified to be excluded from the endpoint objective for Treatment Part B. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) Rate (5 Years) - Treatment Part A and B | At 5 years | All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms). Data was not collected for Treatment Part B. | Percent of participants | NUMBER |
| SECONDARY | Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B | From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months) | All randomized Nivo + Ipi and Nivo participants in Treatment Part B. Prespecified to be collected for Treatment Part B only. The Placebo Arm was prespecified to be excluded from the endpoint objective. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B | From randomization to the date of death (up to approximately 72 months) | All randomized Nivo + Ipi and Nivo participants in Treatment Part B. Prespecified to be collected for Treatment Part B only. The Placebo Arm was prespecified to be excluded from the endpoint objective. | Months | MEDIAN |
| SECONDARY | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | From first dose to 30 days post last dose (up to approximately 40 weeks) | All Treated Participants in Treatment Part A | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | From first dose to 30 days post last dose (up to approximately 40 weeks) | All Treated Participants in Treatment Part B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | From first dose to 100 days post last dose (up to approximately 50 weeks) | All Treated Participants in Treatment Part A | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | From first dose to 100 days post last dose (up to approximately 50 weeks) | All Treated Participants in Treatment Part B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | From first dose to 30 days post last dose (up to approximately 40 weeks) | All treated participants in Treatment Part A with a CTC graded laboratory result for the given parameter from both baseline and on-treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | From first dose to 30 days post last dose (up to approximately 40 weeks) | All treated participants in Treatment Part B with a CTC graded laboratory result for the given parameter from both baseline and on-treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | From first dose to 100 days post last dose (up to approximately 50 weeks) | All treated participants in Treatment Part A with a CTC graded laboratory result for the given parameter from both baseline and on-treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | From first dose to 100 days post last dose (up to approximately 50 weeks) | All treated participants in Treatment Part B with a CTC graded laboratory result for the given parameter from both baseline and on-treatment | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03138512/outcomes