The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
205
Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner
Treatment 300mg vandetanib opel label.
Investigational Site Number : 301
St Leonards, New South Wales, Australia
Investigational Site Number 301
St Leonards, Australia
Investigational Site Number 401
Vienna, Austria
Investigational Site Number : 401
Vienna, Austria
Investigational Site Number : 501
Anderlecht, Belgium
Investigational Site Number 501
Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.
The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.
Time frame: 12 months
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Brussels, Belgium
Hospital De Clinicas De Porto Alegre Site Number : 701
Porto Alegre, Rio Grande do Sul, Brazil
Faculdade de Medicina de Ribeirao Preto - USP Site Number : 702
Ribeirão Preto, São Paulo, Brazil
Investigational Site Number 701
Porto Alegre, Brazil
Investigational Site Number 702
Ribeirão Preto, Brazil
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