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: 2026-04-17

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

2026-04-17

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 in a 1:1 ratio to either Vandetanib 300 mg or Vandetanib 300 mg + Outreach Program arm in randomized treatment period for 12 months. Post completion of randomized treatment period, eligible patients entered continuing treatment period.

Participant milestones

Participant milestones
Measure	Vandetanib 300 mg Patients received vandetanib (3 x 100 milligram \[mg\] tablet form) orally, once daily for 12 months in the randomized treatment period. After completion of randomized treatment period, eligible patients entered the continuing treatment period and had the option to either permanently discontinue the study or continue taking vandetanib (3 x 100 mg tablet form) orally, once daily unless they met any criteria for discontinuation.	Vandetanib 300 mg + Outreach Program Patients received vandetanib (3 x 100 mg tablet form) orally, once daily for 12 months in the randomized treatment period. After completion of randomized treatment period, eligible patients entered the continuing treatment period and had the option to either permanently discontinue the study or continue taking vandetanib (3 x 100 mg tablet form) orally, once daily unless they met any criteria for discontinuation.
Randomized Treatment Period STARTED	102	103
Randomized Treatment Period COMPLETED	77	78
Randomized Treatment Period NOT COMPLETED	25	25
Continuing Treatment Period STARTED	55	55
Continuing Treatment Period COMPLETED	55	55
Continuing Treatment Period NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Vandetanib 300 mg Patients received vandetanib (3 x 100 milligram \[mg\] tablet form) orally, once daily for 12 months in the randomized treatment period. After completion of randomized treatment period, eligible patients entered the continuing treatment period and had the option to either permanently discontinue the study or continue taking vandetanib (3 x 100 mg tablet form) orally, once daily unless they met any criteria for discontinuation.	Vandetanib 300 mg + Outreach Program Patients received vandetanib (3 x 100 mg tablet form) orally, once daily for 12 months in the randomized treatment period. After completion of randomized treatment period, eligible patients entered the continuing treatment period and had the option to either permanently discontinue the study or continue taking vandetanib (3 x 100 mg tablet form) orally, once daily unless they met any criteria for discontinuation.
Randomized Treatment Period Withdrawal by Subject	2	2
Randomized Treatment Period Adverse Event	1	6
Randomized Treatment Period Severe non-compliance to protocol	1	0
Randomized Treatment Period Condition under investigation worsened	16	11
Randomized Treatment Period Lost to Follow-up	1	0
Randomized Treatment Period Other	4	6

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
Race/Ethnicity, Customized White	87 Participants n=130 Participants	84 Participants n=132 Participants	171 Participants n=130 Participants
Age, Continuous	50.8 Years STANDARD_DEVIATION 13.47 • n=130 Participants	53.0 Years STANDARD_DEVIATION 14.34 • n=132 Participants	51.9 Years STANDARD_DEVIATION 13.93 • n=130 Participants
Age, Customized >=18 - <40 Years	21 Participants n=130 Participants	23 Participants n=132 Participants	44 Participants n=130 Participants
Age, Customized >=40 - <65 Years	65 Participants n=130 Participants	52 Participants n=132 Participants	117 Participants n=130 Participants
Age, Customized >=65 - <75 Years	15 Participants n=130 Participants	22 Participants n=132 Participants	37 Participants n=130 Participants
Age, Customized >=75 Years	1 Participants n=130 Participants	6 Participants n=132 Participants	7 Participants n=130 Participants
Sex: Female, Male Female	38 Participants n=130 Participants	37 Participants n=132 Participants	75 Participants n=130 Participants
Sex: Female, Male Male	64 Participants n=130 Participants	66 Participants n=132 Participants	130 Participants n=130 Participants
Race/Ethnicity, Customized Asian	15 Participants n=130 Participants	19 Participants n=132 Participants	34 Participants n=130 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

Randomized Treatment Period: Vandetanib 300 mg + Outreach Program

Serious events: 27 serious events

Other events: 96 other events

Deaths: 16 deaths

Randomized Treatment Period: Vandetanib 300 mg

Serious events: 31 serious events

Other events: 89 other events

Deaths: 11 deaths

Continuing Treatment Period: Vandetanib 300 mg + Outreach Program

Serious events: 18 serious events

Other events: 0 other events

Deaths: 7 deaths

Continuing Treatment Period: Vandetanib 300 mg

Serious events: 21 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610 Ext: 6#

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	Randomized Treatment Period: Vandetanib 300 mg + Outreach Program n=102 participants at risk Patients received vandetanib (3 x 100 mg tablet form) orally, once daily for 12 months in the randomized treatment period.	Randomized Treatment Period: Vandetanib 300 mg n=103 participants at risk Patients received vandetanib (3 x 100 mg tablet form) orally, once daily for 12 months in the randomized treatment period.	Continuing Treatment Period: Vandetanib 300 mg + Outreach Program n=55 participants at risk After completion of randomized treatment period, eligible patients entered the continuing treatment period and had the option to either permanently discontinue the study or continue taking vandetanib (3 x 100 mg tablet form) orally, once daily unless they met any criteria for discontinuation.	Continuing Treatment Period: Vandetanib 300 mg n=55 participants at risk After completion of randomized treatment period, eligible patients entered the continuing treatment period and had the option to either permanently discontinue the study or continue taking vandetanib (3 x 100 mg tablet form) orally, once daily unless they met any criteria for discontinuation.
Blood and lymphatic system disorders Neutropenia	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Acute Myocardial Infarction	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Atrial Fibrillation	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	0.97% 1/103 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	2.0% 2/102 • Number of events 2 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Coronary Artery Disease	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	2.0% 2/102 • Number of events 2 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	0.97% 1/103 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.
Ear and labyrinth disorders Deafness Neurosensory	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Anal Fistula	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	0.97% 1/103 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	2.9% 3/102 • Number of events 3 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Gastric Ulcer	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Jejunal Perforation	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Intestinal Ulcer	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.9% 2/103 • Number of events 3 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Acute	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	0.97% 1/103 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	0.97% 1/103 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	0.97% 1/103 • Number of events 2 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.9% 2/103 • Number of events 2 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.9% 2/103 • Number of events 2 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	3.6% 2/55 • Number of events 2 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Disease Progression	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	5.5% 3/55 • Number of events 3 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Multiple Organ Dysfunction Syndrome	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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 Acute	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.8% 1/55 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	0.97% 1/103 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.98% 1/102 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/103 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 0/55 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	Randomized Treatment Period: Vandetanib 300 mg + Outreach Program n=102 participants at risk Patients received vandetanib (3 x 100 mg tablet form) orally, once daily for 12 months in the randomized treatment period.	Randomized Treatment Period: Vandetanib 300 mg n=103 participants at risk Patients received vandetanib (3 x 100 mg tablet form) orally, once daily for 12 months in the randomized treatment period.	Continuing Treatment Period: Vandetanib 300 mg + Outreach Program n=55 participants at risk After completion of randomized treatment period, eligible patients entered the continuing treatment period and had the option to either permanently discontinue the study or continue taking vandetanib (3 x 100 mg tablet form) orally, once daily unless they met any criteria for discontinuation.	Continuing Treatment Period: Vandetanib 300 mg n=55 participants at risk After completion of randomized treatment period, eligible patients entered the continuing treatment period and had the option to either permanently discontinue the study or continue taking vandetanib (3 x 100 mg tablet form) orally, once daily unless they met any criteria for discontinuation.
Endocrine disorders Hypothyroidism	14.7% 15/102 • Number of events 16 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	14.6% 15/103 • Number of events 16 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	7.8% 8/102 • Number of events 9 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 5/103 • Number of events 5 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	53.9% 55/102 • Number of events 85 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	46.6% 48/103 • Number of events 63 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	6.9% 7/102 • Number of events 7 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 4/103 • Number of events 4 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	25.5% 26/102 • Number of events 34 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	17.5% 18/103 • Number of events 20 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	7.8% 8/102 • Number of events 8 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	10.7% 11/103 • Number of events 13 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	11.8% 12/102 • Number of events 14 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	11.7% 12/103 • Number of events 13 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	17.6% 18/102 • Number of events 19 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	16.5% 17/103 • Number of events 17 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	8.8% 9/102 • Number of events 9 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	9.7% 10/103 • Number of events 10 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	4.9% 5/102 • Number of events 6 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 8/103 • Number of events 8 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	4.9% 5/102 • Number of events 5 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 8/103 • Number of events 9 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	8.8% 9/102 • Number of events 13 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	6.8% 7/103 • Number of events 12 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	11.8% 12/102 • Number of events 12 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	10.7% 11/103 • Number of events 11 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	12.7% 13/102 • Number of events 15 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	18.4% 19/103 • Number of events 20 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	12.7% 13/102 • Number of events 14 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	13.6% 14/103 • Number of events 18 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	8.8% 9/102 • Number of events 11 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 4/103 • Number of events 4 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	6.9% 7/102 • Number of events 8 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 3/103 • Number of events 4 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	0.00% 0/102 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	5.8% 6/103 • Number of events 6 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	11.8% 12/102 • Number of events 16 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 8/103 • Number of events 9 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	3.9% 4/102 • Number of events 4 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	6.8% 7/103 • Number of events 7 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	7.8% 8/102 • Number of events 10 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	8.7% 9/103 • Number of events 9 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	10.8% 11/102 • Number of events 15 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 8/103 • Number of events 8 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	5.9% 6/102 • Number of events 6 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	0.97% 1/103 • Number of events 1 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	6.9% 7/102 • Number of events 9 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	9.7% 10/103 • Number of events 11 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	2.0% 2/102 • Number of events 2 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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% 8/103 • Number of events 8 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	21.6% 22/102 • Number of events 24 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	21.4% 22/103 • Number of events 23 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	6.9% 7/102 • Number of events 8 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	11.7% 12/103 • Number of events 12 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	5.9% 6/102 • Number of events 6 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	1.9% 2/103 • Number of events 2 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	4.9% 5/102 • Number of events 5 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	5.8% 6/103 • Number of events 6 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	12.7% 13/102 • Number of events 18 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	6.8% 7/103 • Number of events 8 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	25.5% 26/102 • Number of events 28 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	24.3% 25/103 • Number of events 31 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	3.9% 4/102 • Number of events 4 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	6.8% 7/103 • Number of events 7 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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	34.3% 35/102 • Number of events 40 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	28.2% 29/103 • Number of events 33 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.	— 0/0 • Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period. Analysis was performed on the safety analysis set. 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.