Trial · NCT01307397
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 | Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0 | Baseline up to 28 days post end of treatment (maximum up to 46 months) | Safety population. Number of participants analyzed = participants with measurable disease at baseline | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation | Baseline up to 28 days post end of treatment (maximum up to 46 months) | Safety population | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With AEs of Special Interest | Baseline up to 28 days post end of treatment (maximum up to 46 months) | Safety population | Percentage of participants | NUMBER |
| PRIMARY | Mean Cumulative Dose of Vemurafenib | Baseline up to end of treatment or death (maximum up to 46 months) | Safety population | Grams | MEAN |
| PRIMARY | Duration of Vemurafenib Treatment | Baseline up to end of treatment or death (maximum upto 46 months) | Safety population | Months | MEAN |
| PRIMARY | Mean Total Vemurafenib Dose Per Day | Baseline up to end of treatment or death (maximum up to 46 months) | Safety population | Grams | MEAN |
| PRIMARY | Dose Intensity of Vemurafenib | Baseline up to end of treatment or death (maximum upto 46 months) | Safety Population | Percentage of planned dose | MEAN |
| SECONDARY | Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status | Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months) | Safety population | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Received Any Concomitant Medications | Baseline up to 46 months | Safety population | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) | Safety population. Number of participants analyzed = participants with measurable disease at baseline. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response | From 1st documentation of confirmed CR or PR to PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until end of the study [up to 46 months]) | Safety population. Number of participants analysed=participants who achieved CR or PR. | Months | MEDIAN |
| SECONDARY | Time to Response | Baseline until first documentation of confirmed CR or PR, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) | Safety population. Number of participants analyzed = participants with measurable disease at baseline. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With PD Assessed According to RECIST v1.1 or Death | Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) | Safety population | Percentage of Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) | Safety population | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Died | Baseline until death (maximum up to 46 months) | Safety population | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Baseline until death (maximum up to 46 months) | Safety population | Months | MEDIAN |
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/NCT01307397/outcomes