Trial Outcomes & Findings for Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment (NCT NCT01298323)

Last Updated: 2025-04-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

205 participants

Primary outcome timeframe

12 months

Results posted on

2025-04-24

Participant Flow

From 25 February 2011 to 27 April 2012, 205 patients were randomized by 33 centers in global 20 countries.

217 patients were screened; 205 patients were randomized to treatment.

Participant milestones

Participant milestones
Measure	Vandetanib 300mg Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily	Vandetanib 300mg + Outreach Program Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
Overall Study STARTED	102	103
Overall Study Ongoing	55	55
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	86	88

Reasons for withdrawal

Reasons for withdrawal
Measure	Vandetanib 300mg Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily	Vandetanib 300mg + Outreach Program Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
Overall Study Adverse Event	2	4
Overall Study Death	11	16
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	6	3
Overall Study Protocol Violation	1	0
Overall Study Other	10	9
Overall Study Ongoing	55	55
Overall Study Eligibility criteria not fulfilled	0	1

Baseline Characteristics

Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vandetanib 300mg n=102 Participants Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily	Vandetanib 300mg + Outreach Program n=103 Participants Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily	Total n=205 Participants Total of all reporting groups
Age, Continuous	50.8 Years STANDARD_DEVIATION 13.47 • n=5 Participants	53.0 Years STANDARD_DEVIATION 14.34 • n=7 Participants	51.9 Years STANDARD_DEVIATION 13.93 • n=5 Participants
Age, Customized >=18 - <40 Years	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Age, Customized >=40 - <65 Years	65 Participants n=5 Participants	52 Participants n=7 Participants	117 Participants n=5 Participants
Age, Customized >=65 - <75 Years	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants
Age, Customized >=75 Years	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	66 Participants n=7 Participants	130 Participants n=5 Participants
Race/Ethnicity, Customized Asian	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized White	87 Participants n=5 Participants	84 Participants n=7 Participants	171 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Number of Months Analyzed is the cumulative sum of number of months that all the participants were present in the study.

Outcome measures

Outcome measures
Measure	Vandetanib 300 mg+Outreach Program n=1513 months Patients on this arm will be contacted by site personnel at week 1 and then every 2 weeks during the first 52 weeks on the study (or prior discontinuation) to detect and possibly treat adverse events sooner than they might have been without the patient outreach, and at a time of lesser CTCAE grade.	Vandetanib 300 mg n=1480 months Patients on this arm will get a standard AE monitoring schedule, similar to that used on previous studies. Patients will be asked about any AEs at scheduled visits and will have the option to contact the investigator at any time if experiencing any AE or symptoms and discuss the best treatment options.
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.	51.65 Percentage of days Standard Deviation 35.548 • Interval -3.44 to 16.37	45.19 Percentage of days Standard Deviation 36.347 • Interval -3.44 to 16.37

Adverse Events

Vandetanib 300mg

Serious events: 30 serious events

Other events: 89 other events

Deaths: 0 deaths

Vandetanib 300mg + Outreach Program

Serious events: 27 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Trial Transparency Team

Sanofi

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Vandetanib 300mg n=103 participants at risk Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily	Vandetanib 300mg + Outreach Program n=102 participants at risk Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
Cardiac disorders Atrial fibrillation	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Large intestine perforation	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
General disorders Asthenia	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Infections and infestations Anal abscess	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Metabolism and nutrition disorders Dehydration	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Metabolism and nutrition disorders Hypercalcaemia	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Nervous system disorders Vocal cord paralysis	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Renal and urinary disorders Nephrolithiasis	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 2 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Respiratory, thoracic and mediastinal disorders Productive cough	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Vascular disorders Venous insufficiency	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Cardiac disorders Angina pectoris	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Cardiac disorders Cardiac arrest	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	2.0% 2/102 • Number of events 2 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Cardiac disorders Myocardial infarction	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Endocrine disorders Ectopic ACTH syndrome	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Abdominal pain	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Crohn's disease	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Diarrhoea	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	2.9% 3/102 • Number of events 3 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Enteritis	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Haematemesis	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Ileus paralytic	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Pancreatitis	1.9% 2/103 • Number of events 3 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Toothache	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Vomiting	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
General disorders Catheter site pain	0.97% 1/103 • Number of events 2 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
General disorders Chest pain	1.9% 2/103 • Number of events 2 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
General disorders Death	1.9% 2/103 • Number of events 2 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
General disorders Sudden death	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Hepatobiliary disorders Cholecystitis	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Hepatobiliary disorders Jaundice	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Infections and infestations Abscess limb	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Infections and infestations Appendicitis	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Infections and infestations Gastroenteritis caliciviral	0.00% 0/103 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.98% 1/102 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Infections and infestations Gastroenteritis viral	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Infections and infestations Lung infection	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Infections and infestations Pneumonia	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Infections and infestations Upper respiratory tract infection	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.

Other adverse events
Measure	Vandetanib 300mg n=103 participants at risk Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily	Vandetanib 300mg + Outreach Program n=102 participants at risk Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
General disorders Asthenia	11.7% 12/103 • Number of events 13 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	11.8% 12/102 • Number of events 14 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Nervous system disorders Headache	7.8% 8/103 • Number of events 9 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	11.8% 12/102 • Number of events 16 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Skin and subcutaneous tissue disorders Erythema	1.9% 2/103 • Number of events 2 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	5.9% 6/102 • Number of events 6 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Skin and subcutaneous tissue disorders Rash	24.3% 25/103 • Number of events 31 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	25.5% 26/102 • Number of events 28 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.8% 7/103 • Number of events 7 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	3.9% 4/102 • Number of events 4 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Endocrine disorders Hypothyroidism	14.6% 15/103 • Number of events 16 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	14.7% 15/102 • Number of events 16 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Constipation	4.9% 5/103 • Number of events 5 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	7.8% 8/102 • Number of events 9 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Diarrhoea	46.6% 48/103 • Number of events 63 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	53.9% 55/102 • Number of events 85 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Dry mouth	3.9% 4/103 • Number of events 4 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	6.9% 7/102 • Number of events 7 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Nausea	18.4% 19/103 • Number of events 21 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	25.5% 26/102 • Number of events 34 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Gastrointestinal disorders Vomiting	10.7% 11/103 • Number of events 13 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	7.8% 8/102 • Number of events 8 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
General disorders Fatigue	16.5% 17/103 • Number of events 17 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	17.6% 18/102 • Number of events 19 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Investigations Alanine aminotransferase increased	9.7% 10/103 • Number of events 10 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	8.8% 9/102 • Number of events 9 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Investigations Aspartate aminotransferase increased	7.8% 8/103 • Number of events 8 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	4.9% 5/102 • Number of events 6 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Investigations Blood creatinine increased	7.8% 8/103 • Number of events 9 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	4.9% 5/102 • Number of events 5 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Investigations Electrocardiogram QT prolonged	6.8% 7/103 • Number of events 12 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	8.8% 9/102 • Number of events 13 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Investigations Weight decreased	10.7% 11/103 • Number of events 11 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	11.8% 12/102 • Number of events 12 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Metabolism and nutrition disorders Decreased appetite	18.4% 19/103 • Number of events 20 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	12.7% 13/102 • Number of events 15 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Metabolism and nutrition disorders Hypocalcaemia	13.6% 14/103 • Number of events 18 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	12.7% 13/102 • Number of events 14 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Musculoskeletal and connective tissue disorders Myalgia	3.9% 4/103 • Number of events 4 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	8.8% 9/102 • Number of events 11 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Nervous system disorders Dizziness	2.9% 3/103 • Number of events 4 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	6.9% 7/102 • Number of events 8 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Nervous system disorders Dysgeusia	5.8% 6/103 • Number of events 6 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	0.00% 0/102 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Psychiatric disorders Anxiety	6.8% 7/103 • Number of events 7 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	3.9% 4/102 • Number of events 4 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Psychiatric disorders Insomnia	8.7% 9/103 • Number of events 9 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	7.8% 8/102 • Number of events 10 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Renal and urinary disorders Proteinuria	7.8% 8/103 • Number of events 8 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	10.8% 11/102 • Number of events 15 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.97% 1/103 • Number of events 1 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	5.9% 6/102 • Number of events 6 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Skin and subcutaneous tissue disorders Acne	9.7% 10/103 • Number of events 11 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	6.9% 7/102 • Number of events 9 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Skin and subcutaneous tissue disorders Alopecia	7.8% 8/103 • Number of events 8 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	2.0% 2/102 • Number of events 2 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Skin and subcutaneous tissue disorders Dermatitis acneiform	21.4% 22/103 • Number of events 23 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	21.6% 22/102 • Number of events 24 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Skin and subcutaneous tissue disorders Dry skin	11.7% 12/103 • Number of events 12 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	6.9% 7/102 • Number of events 8 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	5.8% 6/103 • Number of events 6 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	4.9% 5/102 • Number of events 5 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Skin and subcutaneous tissue disorders Photosensitivity reaction	6.8% 7/103 • Number of events 8 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	12.7% 13/102 • Number of events 18 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Vascular disorders Hypertension	30.1% 31/103 • Number of events 35 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.	34.3% 35/102 • Number of events 40 Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.