Trial Outcomes & Findings for To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer (NCT NCT01496313)
NCT ID: NCT01496313
Last Updated: 2025-10-03
Results Overview
ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
Randomisation to week 60 (maximum)
Results posted on
2025-10-03
Participant Flow
From 8 June 2012 to 2 April 2014, 81 participants were randomized by 29 centers in 9 global countries. The study consisted of a double-blind randomized period and an open-label period.
93 participants were screened; 81 participants were randomized to treatment. Participants with objective disease progression within the 14 months on blinded treatment were given the option to continue to receive vandetanib in open-label period for up to 2 years from the time of study entry. Participants were followed for efficacy during the randomized period only. No further efficacy data was collected in open-label period as pre-specified in the protocol.
Participant milestones
| Measure |
Randomized Period: Vandetanib 150 mg
Oral blinded tablet, taken once daily
|
Randomized Period: Vandetanib 300 mg
Oral blinded tablet, taken once daily
|
Open-label Period: Vandetanib 100 mg
Participants who received vandetanib 150 milligrams (mg) orally once daily but the dose was reduced to vandetanib 100 mg orally once daily for an adverse event (AE) or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 100 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 150 mg
Participants who received vandetanib 150 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to stay on vandetanib 150 mg orally once daily in open-label period for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 200 mg
Participants who received vandetanib 300 mg orally once daily but the dose was reduced to vandetanib 200 mg orally once daily for an AE or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 200 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 300 mg
Participants who received vandetanib 150 mg or 300 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to increase or continue vandetanib 300 mg orally once daily in open-label period respectively for a maximum of 2 years from study entry.
|
|---|---|---|---|---|---|---|
|
Randomized Period (up to 14 Months)
STARTED
|
40
|
41
|
0
|
0
|
0
|
0
|
|
Randomized Period (up to 14 Months)
COMPLETED
|
35
|
26
|
0
|
0
|
0
|
0
|
|
Randomized Period (up to 14 Months)
NOT COMPLETED
|
5
|
15
|
0
|
0
|
0
|
0
|
|
Open-Label Period (Month 14 to 2 Years)
STARTED
|
0
|
0
|
5
|
9
|
8
|
39
|
|
Open-Label Period (Month 14 to 2 Years)
COMPLETED
|
0
|
0
|
3
|
7
|
7
|
28
|
|
Open-Label Period (Month 14 to 2 Years)
NOT COMPLETED
|
0
|
0
|
2
|
2
|
1
|
11
|
Reasons for withdrawal
| Measure |
Randomized Period: Vandetanib 150 mg
Oral blinded tablet, taken once daily
|
Randomized Period: Vandetanib 300 mg
Oral blinded tablet, taken once daily
|
Open-label Period: Vandetanib 100 mg
Participants who received vandetanib 150 milligrams (mg) orally once daily but the dose was reduced to vandetanib 100 mg orally once daily for an adverse event (AE) or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 100 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 150 mg
Participants who received vandetanib 150 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to stay on vandetanib 150 mg orally once daily in open-label period for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 200 mg
Participants who received vandetanib 300 mg orally once daily but the dose was reduced to vandetanib 200 mg orally once daily for an AE or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 200 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 300 mg
Participants who received vandetanib 150 mg or 300 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to increase or continue vandetanib 300 mg orally once daily in open-label period respectively for a maximum of 2 years from study entry.
|
|---|---|---|---|---|---|---|
|
Randomized Period (up to 14 Months)
Adverse Event
|
1
|
5
|
0
|
0
|
0
|
0
|
|
Randomized Period (up to 14 Months)
Condition Under Investigation Worsened
|
2
|
3
|
0
|
0
|
0
|
0
|
|
Randomized Period (up to 14 Months)
Study-specific Discontinuation Criteria
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Randomized Period (up to 14 Months)
Participant Decision
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Randomized Period (up to 14 Months)
Other
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Open-Label Period (Month 14 to 2 Years)
Study-specific Withdrawal Criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Period (Month 14 to 2 Years)
Participant Decision
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Open-Label Period (Month 14 to 2 Years)
Other
|
0
|
0
|
2
|
2
|
1
|
7
|
Baseline Characteristics
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Vandetanib 150 mg
n=40 Participants
Oral blinded tablet, taken once daily
|
Vandetanib 300 mg
n=41 Participants
Oral blinded tablet, taken once daily
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.2 Years
STANDARD_DEVIATION 15.24 • n=5 Participants
|
52.7 Years
STANDARD_DEVIATION 15.42 • n=7 Participants
|
52.5 Years
STANDARD_DEVIATION 15.24 • n=5 Participants
|
|
Age, Customized
>=18 to <40 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Customized
>=40 to <65 years
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Customized
>=65 to <75 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
>=75 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomisation to week 60 (maximum)Population: Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; ORR = CR + PR
ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
Outcome measures
| Measure |
Vandetanib 150 mg
n=40 Participants
Oral blinded tablet, taken once daily
|
Vandetanib 300 mg
n=41 Participants
Oral blinded tablet, taken once daily
|
|---|---|---|
|
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
|
0.20 Proportion of participants
Interval 0.105 to 0.348
|
0.29 Proportion of participants
Interval 0.176 to 0.445
|
SECONDARY outcome
Timeframe: Randomisation to week 60 (maximum)Population: Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Outcome measures
| Measure |
Vandetanib 150 mg
n=40 Participants
Oral blinded tablet, taken once daily
|
Vandetanib 300 mg
n=41 Participants
Oral blinded tablet, taken once daily
|
|---|---|---|
|
Best Objective Response
Complete response
|
0 Participants
|
1 Participants
|
|
Best Objective Response
Partial response
|
8 Participants
|
11 Participants
|
|
Best Objective Response
Stable disease
|
21 Participants
|
23 Participants
|
|
Best Objective Response
Progressive disease
|
9 Participants
|
2 Participants
|
|
Best Objective Response
Non-evaluable
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Randomization to Week 60 (maximum)Population: Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Outcome measures
| Measure |
Vandetanib 150 mg
n=8 Participants
Oral blinded tablet, taken once daily
|
Vandetanib 300 mg
n=12 Participants
Oral blinded tablet, taken once daily
|
|---|---|---|
|
Duration of Objective Response (RECIST 1.1) by Treatment Arm
|
9.8 Months
Interval 2.8 to 11.2
|
8.4 Months
Interval 3.0 to 11.2
|
SECONDARY outcome
Timeframe: Randomization to Week 60 (maximum)Population: Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Outcome measures
| Measure |
Vandetanib 150 mg
n=8 Participants
Oral blinded tablet, taken once daily
|
Vandetanib 300 mg
n=12 Participants
Oral blinded tablet, taken once daily
|
|---|---|---|
|
Time to Objective Response (RECIST 1.1) by Treatment Arm
|
4.2 Months
Interval 2.8 to 11.2
|
4.4 Months
Interval 2.8 to 11.1
|
SECONDARY outcome
Timeframe: Randomization to Week 60 (maximum)Population: Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Outcome measures
| Measure |
Vandetanib 150 mg
n=40 Participants
Oral blinded tablet, taken once daily
|
Vandetanib 300 mg
n=41 Participants
Oral blinded tablet, taken once daily
|
|---|---|---|
|
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Week 12
|
-3.8 % change
Standard Deviation 29.24
|
-17.5 % change
Standard Deviation 18.24
|
|
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Week 24
|
-13.0 % change
Standard Deviation 19.51
|
-24.9 % change
Standard Deviation 22.11
|
|
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Week 36
|
-16.7 % change
Standard Deviation 24.33
|
-29.1 % change
Standard Deviation 22.96
|
|
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Week 48
|
-20.7 % change
Standard Deviation 23.56
|
-30.6 % change
Standard Deviation 25.31
|
|
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Follow-up RECIST assessment
|
-51.0 % change
Standard Deviation 0
|
-11.4 % change
Standard Deviation 67.05
|
|
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Disc. of blinded vandetanib
|
-11.9 % change
Standard Deviation 27.98
|
-27.3 % change
Standard Deviation 29.58
|
SECONDARY outcome
Timeframe: Week 3 to week 60 (maximum)Population: All patients who received at least 1 dose of vandetanib and for whom quantifiable plasma concentration data were available.
Outcome measures
| Measure |
Vandetanib 150 mg
n=40 Participants
Oral blinded tablet, taken once daily
|
Vandetanib 300 mg
n=41 Participants
Oral blinded tablet, taken once daily
|
|---|---|---|
|
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Week 3 (Day 21)
|
428.6 ng/ml
Standard Deviation 140.71
|
786.2 ng/ml
Standard Deviation 243.15
|
|
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Week 8 (Day 56)
|
510.5 ng/ml
Standard Deviation 206.50
|
941.0 ng/ml
Standard Deviation 249.4
|
|
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Week 12 (Day 84)
|
561.4 ng/ml
Standard Deviation 215.66
|
969.9 ng/ml
Standard Deviation 396.18
|
|
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Week 24 (Day 168)
|
549.7 ng/ml
Standard Deviation 189.62
|
1017.7 ng/ml
Standard Deviation 330.89
|
|
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Discontinuation of blinded vandetanib
|
536.8 ng/ml
Standard Deviation 225.34
|
964.0 ng/ml
Standard Deviation 357.30
|
Adverse Events
Randomized Period: Vandetanib 150 mg
Serious events: 9 serious events
Other events: 38 other events
Deaths: 1 deaths
Randomized Period: Vandetanib 300 mg
Serious events: 9 serious events
Other events: 40 other events
Deaths: 6 deaths
Open-label Period: Vandetanib 100 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Open-label Period: Vandetanib 150 mg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Open-label Period: Vandetanib 200 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Open-label Period: Vandetanib 300 mg
Serious events: 11 serious events
Other events: 31 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Randomized Period: Vandetanib 150 mg
n=40 participants at risk
Oral blinded tablet, taken once daily
|
Randomized Period: Vandetanib 300 mg
n=41 participants at risk
Oral blinded tablet, taken once daily
|
Open-label Period: Vandetanib 100 mg
n=5 participants at risk
Participants who received vandetanib 150 mg orally once daily but the dose was reduced to vandetanib 100 mg orally once daily for an AE or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 100 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 150 mg
n=9 participants at risk
Participants who received vandetanib 150 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to stay on vandetanib 150 mg orally once daily in open-label period for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 200 mg
n=8 participants at risk
Participants who received vandetanib 300 mg orally once daily but the dose was reduced to vandetanib 200 mg orally once daily for an AE or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 200 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 300 mg
n=39 participants at risk
Participants who received vandetanib 150 mg or 300 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to increase or continue vandetanib 300 mg orally once daily in open-label period respectively for a maximum of 2 years from study entry.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Duodenal Ulcer Perforation
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Cardiac disorders
Angina Pectoris
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Oesophageal Obstruction
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
General disorders
Drug Interaction
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
General disorders
Malaise
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
General disorders
Sudden Death
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Abscess
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Neurocysticercosis
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Pneumonia Aspiration
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Viral Infection
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Injury, poisoning and procedural complications
Post Procedural Fistula
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Laryngeal Neoplasm
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Miller Fisher Syndrome
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Paraesthesia
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Spinal Cord Compression
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Tremor
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Renal and urinary disorders
Calculus Ureteric
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Haemorrhage
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Obstruction
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
|
2.5%
1/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
Other adverse events
| Measure |
Randomized Period: Vandetanib 150 mg
n=40 participants at risk
Oral blinded tablet, taken once daily
|
Randomized Period: Vandetanib 300 mg
n=41 participants at risk
Oral blinded tablet, taken once daily
|
Open-label Period: Vandetanib 100 mg
n=5 participants at risk
Participants who received vandetanib 150 mg orally once daily but the dose was reduced to vandetanib 100 mg orally once daily for an AE or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 100 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 150 mg
n=9 participants at risk
Participants who received vandetanib 150 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to stay on vandetanib 150 mg orally once daily in open-label period for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 200 mg
n=8 participants at risk
Participants who received vandetanib 300 mg orally once daily but the dose was reduced to vandetanib 200 mg orally once daily for an AE or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 200 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
|
Open-label Period: Vandetanib 300 mg
n=39 participants at risk
Participants who received vandetanib 150 mg or 300 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to increase or continue vandetanib 300 mg orally once daily in open-label period respectively for a maximum of 2 years from study entry.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
2.5%
1/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.3%
3/41 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Endocrine disorders
Hypothyroidism
|
7.5%
3/40 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.2%
5/41 • Number of events 6 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Eye disorders
Corneal Opacity
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
9.8%
4/41 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Eye disorders
Eye Pain
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Eye disorders
Keratitis
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Eye disorders
Keratopathy
|
15.0%
6/40 • Number of events 6 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
34.1%
14/41 • Number of events 17 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
40.0%
2/5 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
22.2%
2/9 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
15.4%
6/39 • Number of events 7 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.3%
3/41 • Number of events 4 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.3%
3/41 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
15/40 • Number of events 17 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
43.9%
18/41 • Number of events 21 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
25.0%
2/8 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
17.9%
7/39 • Number of events 7 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Dry Mouth
|
10.0%
4/40 • Number of events 4 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
9.8%
4/41 • Number of events 4 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
4/40 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.2%
5/41 • Number of events 6 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.8%
5/39 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.7%
3/39 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
General disorders
Asthenia
|
12.5%
5/40 • Number of events 6 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
17.1%
7/41 • Number of events 7 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.5%
8/39 • Number of events 10 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
General disorders
Fatigue
|
20.0%
8/40 • Number of events 8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
17.1%
7/41 • Number of events 7 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
25.0%
2/8 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.7%
3/39 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
9.8%
4/41 • Number of events 4 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
General disorders
Oedema Peripheral
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
General disorders
Pyrexia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Conjunctivitis
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Influenza
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Lower Respiratory Tract Infection Bacterial
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Paronychia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Rash Pustular
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
22.2%
2/9 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Infections and infestations
Vulval Abscess
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Alanine Aminotransferase Increased
|
12.5%
5/40 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
17.1%
7/41 • Number of events 7 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
15.4%
6/39 • Number of events 7 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.5%
3/40 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
14.6%
6/41 • Number of events 6 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
15.4%
6/39 • Number of events 7 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Blood Bilirubin Increased
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
5.0%
2/40 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Blood Creatinine Increased
|
12.5%
5/40 • Number of events 6 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.7%
3/39 • Number of events 4 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Blood Glucose Increased
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Blood Thyroid Stimulating Hormone Decreased
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
30.0%
12/40 • Number of events 12 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
22.0%
9/41 • Number of events 11 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.8%
5/39 • Number of events 8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Ejection Fraction Decreased
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Electrocardiogram Qt Prolonged
|
12.5%
5/40 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
34.1%
14/41 • Number of events 15 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
17.9%
7/39 • Number of events 8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Platelet Count Decreased
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
Weight Decreased
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.2%
5/41 • Number of events 6 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
10.3%
4/39 • Number of events 4 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
17.1%
7/41 • Number of events 8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
17.5%
7/40 • Number of events 8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
24.4%
10/41 • Number of events 11 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
40.0%
2/5 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.5%
8/39 • Number of events 9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
2/40 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
17.1%
7/41 • Number of events 8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
40.0%
2/5 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
15.4%
6/39 • Number of events 8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
4/40 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
14.6%
6/41 • Number of events 9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
40.0%
2/5 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.8%
5/39 • Number of events 6 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.7%
3/39 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.3%
3/41 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
7.5%
3/40 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
7.5%
3/40 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Bone
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Disturbance In Attention
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Head Titubation
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.7%
3/39 • Number of events 4 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Nervous system disorders
Tremor
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.3%
3/41 • Number of events 4 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Psychiatric disorders
Depression
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
14.6%
6/41 • Number of events 6 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
4/40 • Number of events 6 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.5%
3/40 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Renal and urinary disorders
Proteinuria
|
15.0%
6/40 • Number of events 7 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 4 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Renal and urinary disorders
Renal Pain
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.7%
3/39 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Dysaesthesia Pharynx
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.7%
3/39 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Inflammation
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.3%
3/41 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.5%
3/40 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
15.0%
6/40 • Number of events 7 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
14.6%
6/41 • Number of events 8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.6%
1/39 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
12.5%
5/40 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.2%
5/41 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.7%
3/39 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
4.9%
2/41 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
9.8%
4/41 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.3%
3/41 • Number of events 4 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
5.1%
2/39 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
7.7%
3/39 • Number of events 3 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
8/40 • Number of events 9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
31.7%
13/41 • Number of events 19 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.8%
5/39 • Number of events 5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
2.4%
1/41 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/5 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
12.5%
1/8 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Surgical and medical procedures
Cataract Operation
|
0.00%
0/40 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/41 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 2 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/9 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/39 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
|
Vascular disorders
Hypertension
|
20.0%
8/40 • Number of events 10 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
26.8%
11/41 • Number of events 14 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
11.1%
1/9 • Number of events 1 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
0.00%
0/8 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
15.4%
6/39 • Number of events 7 • Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
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