Statements (56)
Predicate | Object |
---|---|
gptkbp:instance_of |
gptkb:legal_case
|
gptkbp:bfsLayer |
6
|
gptkbp:bfsParent |
gptkb:vemurafenib
|
gptkbp:analysis |
statistical analysis
|
gptkbp:analyzes |
gptkb:vemurafenib
gptkb:cobimetinib Dr. Paul Chapman |
gptkbp:business_model |
gptkb:battle
|
gptkbp:clinical_trial |
interventional
NC T01039550 demonstrated efficacy of combination therapy. |
gptkbp:collaborations |
gptkb:Roche
gptkb:Astellas_Pharma |
gptkbp:collection |
clinical assessments
laboratory tests patient-reported outcomes |
gptkbp:criteria |
age 18 or older
measurable disease prior treatment with BRAF inhibitors BRAF V600 mutation-positive status pregnancy or breastfeeding uncontrolled medical conditions |
gptkbp:duration |
up to 12 months
|
gptkbp:events |
24 months
|
gptkbp:focuses_on |
gptkb:healthcare_organization
|
gptkbp:frequency |
every 4 weeks
|
https://www.w3.org/2000/01/rdf-schema#label |
BRIM-3
|
gptkbp:is_compared_to |
cobimetinib plus vemurafenib vs vemurafenib alone
|
gptkbp:is_studied_in |
multicenter study
|
gptkbp:is_tested_for |
Phase III
|
gptkbp:launch_date |
2011-06-01
|
gptkbp:location |
multiple sites worldwide
|
gptkbp:participants |
overall survival
progression-free survival |
gptkbp:population |
adults with melanoma
|
gptkbp:provides_information_on |
available upon request
|
gptkbp:published_year |
gptkb:2015
|
gptkbp:receives_funding_from |
gptkb:Company
|
gptkbp:recorded_by |
gptkb:battle
large |
gptkbp:result |
gptkb:The_New_England_Journal_of_Medicine
improved progression-free survival |
gptkbp:side_effect |
fatigue
nausea diarrhea skin rash increased liver enzymes |
gptkbp:sponsor |
gptkb:Genentech
|
gptkbp:status |
completed
|
gptkbp:student_enrollment |
495 participants
|
gptkbp:targets |
BRAF V600 mutation-positive melanoma
|
gptkbp:treatment |
two
changed treatment guidelines for melanoma |
gptkbp:vision |
open label
|
gptkbp:year |
2014-12-01
2014-06-01 |