Trial · NCT02737475
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | From first dose to 28 days after first dose | All treated participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants Experiencing Adverse Events (AEs) | From first dose to 100 days after last dose (up to approximately 2.5 years) | All treated participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 100 days after last dose (up to approximately 2.5 years) | All treated participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose to 100 days after last dose (up to approximately 2.5 years) | All treated participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participant Deaths | From first dose to study completion (up to approximately 4 years 5 months) | All treated participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology) | From baseline to 100 days after last dose (up to approximately 2.5 years) | All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION) | From baseline to 100 days after last dose (up to approximately 2.5 years) | All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING ) | From baseline to 100 days after last dose (up to approximately 2.5 years) | All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | From baseline up to approximately 2.5 years | Response Evaluable Participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | From baseline up to approximately 2.5 years | The number of responders within each tumor type was not sufficient for analysis. (Parts 1-8) | Weeks | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Rate at 24 Weeks | 24 weeks after first dose | All treated Participants (Parts 1-8) | Percentage of participants | NUMBER |
| SECONDARY | Cmax: Maximum Observed Serum Concentration | Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose) | Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9) | NG/ML | GEOMETRIC_MEAN |
| SECONDARY | Tmax: Time of Maximum Observed Serum Concentration | Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose) | Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9) | Hours | MEDIAN |
| SECONDARY | AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t | Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose) | Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9) | H*NG/ML | GEOMETRIC_MEAN |
| SECONDARY | AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval | Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose) | Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9) | H*NG/ML | GEOMETRIC_MEAN |
| SECONDARY | Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected | Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose) | Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9) | NG/ML | GEOMETRIC_MEAN |
| SECONDARY | CLT: Total Body Clearance | Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose) | Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9) | L/H | GEOMETRIC_MEAN |
| SECONDARY | Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) | Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose) | Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9) | NG/ML | GEOMETRIC_MEAN |
| SECONDARY | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax) | Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose) | Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9) | NG/ML | GEOMETRIC_MEAN |
| SECONDARY | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC) | Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose) | Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9) | H*NG/ML | GEOMETRIC_MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT02737475/outcomes