Trial · NCT02181738
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C | From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 28 months) | All treated Cohort A, B and C participants | Percentage of Particpants | NUMBER |
| PRIMARY | Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D | From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) | All Cohort D participants treated in the monotherapy and combination therapy phases. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C | From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months). | All treated Cohort A, B and C participants with objective response of CR or PR. | Months | MEDIAN |
| SECONDARY | Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C | From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months) | All treated Cohort A, B and C participants | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C | From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months) | All treated Cohort A, B and C participants who had a BOR of CR. | Months | MEDIAN |
| SECONDARY | Partial Remission (PR) Rate Based on IRRC Assessments in Cohorts A, B, and C | From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months) | All treated Cohort A, B and C participants | Percentage of Participants | NUMBER |
| SECONDARY | Duration of PR Based on IRRC Assessments in Cohorts A, B, and C | From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months) | All treated Cohort A, B and C participants who had a BOR of PR. | Months | MEDIAN |
| SECONDARY | Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C | From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months) | All treated Cohort A, B and C participants | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C | From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months) | All treated Cohort A, B and C participants who had a BOR of CR or PR. | Months | MEDIAN |
| SECONDARY | Treatment Discontinuation Rate in Cohort D | From first dose up until the date of treatment discontinuation (up to approximately 100 months). | All Cohort D participants treated in the monotherapy and combination therapy phases. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Died in Cohort D | From first dose of the considered therapy phase to 100 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 10 months up to a maximum of 13 months) | All Cohort D participants treated in the monotherapy and combination therapy phases. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (AEs) in Cohort D | From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) | All treated participants in Cohort D | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) in Cohort D | From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) | All treated participants in Cohort D | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With AEs Leading to Discontinuation in Cohort D | From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) | All treated participants in Cohort D | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With AEs Leading to Dose Delay in Cohort D | From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) | All treated participants in Cohort D | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Select AEs in Cohort D | From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) | All treated participants in Cohort D | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase | From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months) | All participants treated in the Cohort D monotherapy phase who had at least one on-treatment TSH measurement during the monotherapy phase | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase | From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months) | All participants treated in the Cohort D combination therapy phase who had at least one on-treatment AST, ALT and/or bilirubin test measurement during the combination therapy phase | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase | From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months) | All participants treated in the Cohort D monotherapy phase | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase | From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months) | All participants treated in the Cohort D combination therapy phase with at least one on-treatment laboratory measurement | 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/NCT02181738/outcomes