38-501 : BRAFTOVI/MEKTOVI Combination Therapy Specified Drug Use Survey (ML)
Not Applicable
- Conditions
- radically unresectable malignant melanoma with a BRAF gene mutation
- Registration Number
- JPRN-jRCT2011210010
- Lead Sponsor
- Kuro Toshihiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
All patients with radically unresectable malignant melanoma with a BRAF gene mutation for whom BRAFTOVI/MEKTOVI Combination Therapy is performed
Exclusion Criteria
patients who have not received BRAFTOVI and/or MEKTOVI
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [Safety]Occurrence status of adverse drug reactions and infections, Occurrence status of adverse drug reactions corresponding to specified safety concerns, Factors that are considered to affect safety<br>Specified safety concerns: Skin malignant tumor, palmar-plantar erythrodysaesthesia syndrome, eye disorders, cardiac dysfunction, hypertension, rhabdomyolysis, hepatic dysfunction, and haemorrhage
- Secondary Outcome Measures
Name Time Method