38-501 : BRAFTOVI/MEKTOVI Combination Therapy Specified Drug Use Survey (ML)

JRCT ID: jRCT2011210010

Registered date:25/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: radically unresectable malignant melanoma with a BRAF gene mutation
• Date of first enrollment: 27/02/2019
• Target sample size: 150
• Study type: Observational
• Intervention(s): none

Outcome(s)

Primary Outcome

[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
Specified safety concerns: Skin malignant tumor, palmar-plantar erythrodysaesthesia syndrome, eye disorders, cardiac dysfunction, hypertension, rhabdomyolysis, hepatic dysfunction, and haemorrhage

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: All patients with radically unresectable malignant melanoma with a BRAF gene mutation for whom BRAFTOVI/MEKTOVI Combination Therapy is performed
• Exclude criteria: patients who have not received BRAFTOVI and/or MEKTOVI

Related Information

• Primary Sponsor: Kuro Toshihiko