A Survey of Experiences and Opinions Regarding Skin Toxicities Associated with Vectibix Among mCRC Patients

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  VECTIBIX
• Medical condition to be studied:
  Skin toxicity

Population studied

• Short description of the study population:
  Patients needed to be at least 18 years of age, have a diagnosis of metastatic colorectal cancer (mCRC) and provide consent to participate. ; Inclusion Criteria; 1. 18 years of age or older; 2. Have a self-reported physician diagnosis of mCRC; 3. Have consented to participate; Exclusion Criteria; Patients not meeting inclusion criteria will be excluded. Additional exclusion criteria include treatment with cetuximab at any point.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Metastatic colorectal cancer (mCRC) patients
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  To assess the experiences and opinions regarding dermatologic toxicities that may develop among mCRC patients who are treated with and without Vectibix.
• Outcomes:
  Among mCRC Vectibix patients• Describe mCRC patient opinions regarding the risk of skin • Characterize the timing and severity of rash • Describe the education they received to prevent and manage rash • Describe management strategies • Describe the impact on quality of lifeAmong mCRC non-Vectibix patients • Describe patient opinions regarding the risk of skin rash
• Data analysis plan:
  The following descriptive statistics will be analyzed:• Proportion of mCRC patients who agree to participate in the study• Proportion of mCRC patients who meet the criteria for participation (i.e. eligibility rate)The consent rate will be calculated as the proportion of eligible patients who consent to participate in the survey out of all eligible patients.

Documents

Study results

20190025_Adelphi ORSR_08.24.20_abstract (002)_Redacted