Trial · NCT03336216
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) by BICR | From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months) | All Efficacy Participants: Randomized population with at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) by Investigator | From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months) | All Efficacy Participants: Randomized population with at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Progression Free Survival Rate (PFSR) by BICR | At 6, 9, and 12 months | All Efficacy Participants: Randomized population with at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival Rate (PFSR) by Investigator | At 6, 9, and 12 months | All Efficacy Participants: Randomized population with at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) by BICR | From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months) | All Efficacy Participants: Randomized population with at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) by Investigator | From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months) | All Efficacy Participants: Randomized population with at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) by BICR | From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months) | All Confirmed Responders: All efficacy evaluable participants (randomized population with at least one dose of study drug) with CR or PR | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) by Investigator | From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months) | All Confirmed Responders: All efficacy evaluable participants (randomized population with at least one dose of study drug) with CR or PR | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to the date of death to any cause (up to approximately 65 months) | All Efficacy Participants: Randomized population with at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Overall Survival Rates (OSR) | At 6 months, 1 year, and 2 years | All Efficacy Participants: Randomized population with at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | The Number of Participants With Adverse Events (AEs) | From first dose to 100 days after last dose of study therapy (up to approximately 51 months) | All treated participants: All participants who take at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants With Serious Adverse Events (SAEs) | From first dose to 100 days after last dose of study therapy (up to approximately 51 months) | All treated participants: All participants who take at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants With Adverse Events (AEs) Leading to Discontinuation | From first dose to 100 days after last dose of study therapy (up to approximately 51 months) | All treated participants: All participants who take at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants Who Died | From first dose to 150 days after last dose of study therapy (up to approximately 53 months) | All treated participants: All participants who take at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants Who Experienced Abnormal Hepatic Tests | From first dose and 100 days after last dose of study therapy (up to approximately 51 months) | All treated participants with at least one on-treatment hepatic measurement | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | From first dose and 100 days after last dose of study therapy (up to approximately 51 months) | All treated participants with at least one on-treatment thyroid stimulating hormone (TSH) 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.
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GET https://conductscience.org/api/trials/v1/NCT03336216/outcomes