A Randomized,Int.,Open-Label Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients With Locally Advanced or Metastatic MTC Experience Grade 2 or Higher AEs in the First 12 Months of Treatment With Vandetanib
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program.
AEs will be collected over 52 weeks on treatment
Lars Bastholt, MD DPM
Odense University Hospital
Australia: Department of Health and Ageing Therapeutic Goods Administration