Trial Outcomes & Findings for Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer (NCT NCT00537095)
NCT ID: NCT00537095
Last Updated: 2024-04-19
Results Overview
modified RECIST V1.0 was used.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
164 participants
Primary outcome timeframe
Time from date of randomization to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessment
Results posted on
2024-04-19
Participant Flow
A total of 164 participants were enrolled in the study, out of which only 145 participants were randomized into 2 arms to receive vandetanib 300 mg once daily oral dose or placebo. Participants were randomized by 16 active centers in 7 European countries from September 28th, 2007 to October 16th, 2008.
The main reason for non-randomization was non-respect of eligibility criteria.
Participant milestones
| Measure |
ZD6474/ ZD6474
Participants received vandetanib (ZD6474) 300 mg orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever comes first. Participants still receiving vandetanib (ZD6474) treatment at the end of the trial were offered the opportunity to enter the open label phase and continue to receive vandetanib (ZD6474) treatment as long as they still benefitted of it per investigator judgment or until subsequent anti-cancer therapy.
|
PLACEBO/ ZD6474
Participants received placebo matching to vandetanib (ZD6474) tablet orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever occurred first. Participants who experienced disease progression during the randomized phase were offered to enter the open-label phase and receive vandetanib (ZD6474) if, as long as they benefitted of it or until subsequent anti-cancer therapy.
|
|---|---|---|
|
Randomized Treatment Period (433 Days)
STARTED
|
72
|
73
|
|
Randomized Treatment Period (433 Days)
Safety Population
|
73
|
72
|
|
Randomized Treatment Period (433 Days)
COMPLETED
|
0
|
0
|
|
Randomized Treatment Period (433 Days)
NOT COMPLETED
|
72
|
73
|
|
Open-label Period (590 Days)
STARTED
|
28
|
59
|
|
Open-label Period (590 Days)
Safety Population
|
29
|
58
|
|
Open-label Period (590 Days)
COMPLETED
|
16
|
20
|
|
Open-label Period (590 Days)
NOT COMPLETED
|
12
|
39
|
Reasons for withdrawal
| Measure |
ZD6474/ ZD6474
Participants received vandetanib (ZD6474) 300 mg orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever comes first. Participants still receiving vandetanib (ZD6474) treatment at the end of the trial were offered the opportunity to enter the open label phase and continue to receive vandetanib (ZD6474) treatment as long as they still benefitted of it per investigator judgment or until subsequent anti-cancer therapy.
|
PLACEBO/ ZD6474
Participants received placebo matching to vandetanib (ZD6474) tablet orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever occurred first. Participants who experienced disease progression during the randomized phase were offered to enter the open-label phase and receive vandetanib (ZD6474) if, as long as they benefitted of it or until subsequent anti-cancer therapy.
|
|---|---|---|
|
Randomized Treatment Period (433 Days)
Adverse Event
|
24
|
4
|
|
Randomized Treatment Period (433 Days)
Objective Disease Progression
|
21
|
48
|
|
Randomized Treatment Period (433 Days)
Death
|
3
|
1
|
|
Randomized Treatment Period (433 Days)
Withdrawal by Subject
|
2
|
2
|
|
Randomized Treatment Period (433 Days)
Subjective/ Clinic Progression or Lack of Efficacy
|
1
|
2
|
|
Randomized Treatment Period (433 Days)
As per protocol (after 12 months of blinded treatment)
|
21
|
16
|
|
Open-label Period (590 Days)
Adverse Event
|
2
|
11
|
|
Open-label Period (590 Days)
Objective Disease Progression
|
2
|
21
|
|
Open-label Period (590 Days)
Death
|
2
|
2
|
|
Open-label Period (590 Days)
Withdrawal by Subject
|
1
|
2
|
|
Open-label Period (590 Days)
Subjective/ Clinic Progression or Lack of Efficacy
|
5
|
3
|
Baseline Characteristics
Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer
Baseline characteristics by cohort
| Measure |
ZD6474
n=72 Participants
ZD6474, Vandetanib 300mg
|
PLACEBO
n=73 Participants
PLACEBO
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 year
STANDARD_DEVIATION 11.21 • n=99 Participants
|
63.8 year
STANDARD_DEVIATION 11.59 • n=107 Participants
|
63 year
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Time from date of randomization to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessmentmodified RECIST V1.0 was used.
Outcome measures
| Measure |
ZD6474
n=72 Participants
ZD6474, Vandetanib 300mg
|
PLACEBO
n=73 Participants
PLACEBO
|
|---|---|---|
|
Time to Tumor Progression
|
334 days
Interval 232.0 to 421.0
|
176 days
Interval 119.0 to 267.0
|
SECONDARY outcome
Timeframe: 6 months after randomizationnumber of participants that achieved disease control 6 months after randomization. Best objective response of complete response + partial response + stable disease \> 24 weeks according to RECIST criteria
Outcome measures
| Measure |
ZD6474
n=72 Participants
ZD6474, Vandetanib 300mg
|
PLACEBO
n=73 Participants
PLACEBO
|
|---|---|---|
|
Disease Control Rate at 6 Months
|
41 participants
|
31 participants
|
SECONDARY outcome
Timeframe: 46.7 monthsBest objective response of the participants from an average of 46.7 months, defined as complete or partial response according to RECIST criteria
Outcome measures
| Measure |
ZD6474
n=72 Participants
ZD6474, Vandetanib 300mg
|
PLACEBO
n=73 Participants
PLACEBO
|
|---|---|---|
|
Objective Response Rate
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: time from randomization to date of deathPopulation: For the efficacy part, 72 were randomized to received ZD6474 and 73 placebo. For the safety part, 73 patients received at least one dose of ZD6474 and 72 placebo
Interim analysis time to date of randomization to date of death (data not mature at the time of this analysis, so number of deaths displayed instead.
Outcome measures
| Measure |
ZD6474
n=72 Participants
ZD6474, Vandetanib 300mg
|
PLACEBO
n=73 Participants
PLACEBO
|
|---|---|---|
|
Time to Death
|
19 participants
|
21 participants
|
Adverse Events
Randomized Treatment Period: Vandetanib (ZD6474)
Serious events: 20 serious events
Other events: 72 other events
Deaths: 0 deaths
Randomized Treatment Period: Placebo
Serious events: 12 serious events
Other events: 65 other events
Deaths: 0 deaths
Open-Label Treatment Period: Vandetanib/Vandetinib (ZD6474)
Serious events: 12 serious events
Other events: 17 other events
Deaths: 0 deaths
Open-Label Treatment Period: Placebo/Vandetinib (ZD6474)
Serious events: 17 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Treatment Period: Vandetanib (ZD6474)
n=73 participants at risk
Participants received vandetanib (ZD6474) 300 mg orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever comes first.
|
Randomized Treatment Period: Placebo
n=72 participants at risk
Participants received placebo matching to vandetanib (ZD6474) tablet orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever occurred first.
|
Open-Label Treatment Period: Vandetanib/Vandetinib (ZD6474)
n=29 participants at risk
Participants still receiving vandetanib (ZD6474) treatment at the end of the trial were offered the opportunity to enter the open label phase and continue to receive vandetanib (ZD6474) treatment as long as they still benefitted of it per investigator judgment or until subsequent anti-cancer therapy.
|
Open-Label Treatment Period: Placebo/Vandetinib (ZD6474)
n=58 participants at risk
Participants who experienced disease progression during the randomized phase were offered to enter the open-label phase and receive vandetanib (ZD6474) if, as long as they benefitted of it or until subsequent anti-cancer therapy.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Cardiac disorders
Angina Pectoris
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Cardiac disorders
Atrioventricular Block
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Cardiac disorders
Bradyarrhythmia
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Cardiac disorders
Sinus Bradycardia
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Cardiac disorders
Torsade De Pointes
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
General disorders
General Physical Health Deterioration
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Hepatobiliary disorders
Gallbladder Rupture
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Pneumonia
|
2.7%
2/73 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.2%
3/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Urinary Tract Infection Viral
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Injury, poisoning and procedural complications
Drug Exposure During Pregnancy
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Investigations
Electrocardiogram Qt Prolonged
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Cluster Headache
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Loss Of Consciousness
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Syncope
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
2/73 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Cutaneous Lupus Erythematosus
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Skin Haemorrhage
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
Other adverse events
| Measure |
Randomized Treatment Period: Vandetanib (ZD6474)
n=73 participants at risk
Participants received vandetanib (ZD6474) 300 mg orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever comes first.
|
Randomized Treatment Period: Placebo
n=72 participants at risk
Participants received placebo matching to vandetanib (ZD6474) tablet orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever occurred first.
|
Open-Label Treatment Period: Vandetanib/Vandetinib (ZD6474)
n=29 participants at risk
Participants still receiving vandetanib (ZD6474) treatment at the end of the trial were offered the opportunity to enter the open label phase and continue to receive vandetanib (ZD6474) treatment as long as they still benefitted of it per investigator judgment or until subsequent anti-cancer therapy.
|
Open-Label Treatment Period: Placebo/Vandetinib (ZD6474)
n=58 participants at risk
Participants who experienced disease progression during the randomized phase were offered to enter the open-label phase and receive vandetanib (ZD6474) if, as long as they benefitted of it or until subsequent anti-cancer therapy.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.6%
4/72 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
2/58 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.5%
4/73 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.5%
4/73 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Ear and labyrinth disorders
Vertigo
|
12.3%
9/73 • Number of events 12 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
9.7%
7/72 • Number of events 7 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.2%
3/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Eye disorders
Conjunctivitis
|
5.5%
4/73 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
2/58 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Eye disorders
Vision Blurred
|
6.8%
5/73 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.3%
9/73 • Number of events 10 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
5/72 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
10.3%
6/58 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.6%
4/72 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
2/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Cheilitis
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.2%
3/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Constipation
|
6.8%
5/73 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
8.3%
6/72 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
13.8%
4/29 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
8.6%
5/58 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
72.6%
53/73 • Number of events 66 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
16.7%
12/72 • Number of events 14 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
17.2%
5/29 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
69.0%
40/58 • Number of events 41 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.8%
5/73 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
2.8%
2/72 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.5%
4/73 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
2.8%
2/72 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Nausea
|
24.7%
18/73 • Number of events 21 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
15.3%
11/72 • Number of events 11 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
19.0%
11/58 • Number of events 12 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
6/73 • Number of events 7 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
5/72 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
4/58 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
General disorders
Asthenia
|
26.0%
19/73 • Number of events 19 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
22.2%
16/72 • Number of events 21 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
17.2%
10/58 • Number of events 12 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
General disorders
Chest Pain
|
5.5%
4/73 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.6%
4/72 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
4/58 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
General disorders
Fatigue
|
23.3%
17/73 • Number of events 19 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
18.1%
13/72 • Number of events 13 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
10.3%
3/29 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
15.5%
9/58 • Number of events 9 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Bronchitis
|
5.5%
4/73 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
5/72 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
2/58 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Folliculitis
|
9.6%
7/73 • Number of events 9 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
4.2%
3/72 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
8.6%
5/58 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.6%
4/72 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Investigations
Alanine Aminotransferase Increased
|
2.7%
2/73 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
8.6%
5/58 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Investigations
Electrocardiogram Qt Prolonged
|
21.9%
16/73 • Number of events 17 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
8.6%
5/58 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Investigations
Weight Decreased
|
17.8%
13/73 • Number of events 13 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
5/72 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
10.3%
6/58 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
26.0%
19/73 • Number of events 20 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
13.9%
10/72 • Number of events 11 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
15.5%
9/58 • Number of events 9 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.2%
6/73 • Number of events 7 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.6%
4/72 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
10.3%
6/58 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.3%
9/73 • Number of events 11 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
4.2%
3/72 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
2/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
4.2%
3/72 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
2/58 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.5%
4/73 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
8.3%
6/72 • Number of events 7 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.1%
3/73 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
2.8%
2/72 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.2%
3/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
2.8%
2/72 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.2%
3/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/73 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.6%
4/72 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
8.2%
6/73 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
5/72 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Nervous system disorders
Headache
|
16.4%
12/73 • Number of events 13 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
19.4%
14/72 • Number of events 14 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
4/58 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Psychiatric disorders
Anxiety
|
6.8%
5/73 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
4/58 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Psychiatric disorders
Depression
|
11.0%
8/73 • Number of events 8 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Psychiatric disorders
Insomnia
|
11.0%
8/73 • Number of events 8 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
4.2%
3/72 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
8.6%
5/58 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
4/73 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
12.5%
9/72 • Number of events 9 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
12.1%
7/58 • Number of events 7 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.5%
4/73 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
2.8%
2/72 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
8.6%
5/58 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.8%
5/73 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
12.5%
9/72 • Number of events 11 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
2/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.8%
5/73 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.1%
3/73 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
2.8%
2/72 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.2%
3/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
27.4%
20/73 • Number of events 21 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
8.3%
6/72 • Number of events 10 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
24.1%
14/58 • Number of events 15 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.5%
4/73 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.2%
3/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
8.2%
6/73 • Number of events 6 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
2/58 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
16.4%
12/73 • Number of events 12 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.6%
4/72 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.2%
3/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.5%
4/73 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.8%
5/73 • Number of events 9 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.6%
4/72 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
4/58 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
17.8%
13/73 • Number of events 16 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
2.8%
2/72 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.2%
3/58 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
8.2%
6/73 • Number of events 8 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.5%
4/73 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.6%
4/72 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
10.3%
6/58 • Number of events 7 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.3%
17/73 • Number of events 17 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
4.2%
3/72 • Number of events 3 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
19.0%
11/58 • Number of events 11 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
2.7%
2/73 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.4%
1/72 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
1.7%
1/58 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
5.5%
4/73 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/29 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
4/58 • Number of events 5 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Vascular disorders
Hypertension
|
34.2%
25/73 • Number of events 26 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
5.6%
4/72 • Number of events 4 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
3.4%
1/29 • Number of events 1 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
32.8%
19/58 • Number of events 19 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
|
Vascular disorders
Peripheral Coldness
|
0.00%
0/73 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/72 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
6.9%
2/29 • Number of events 2 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
0.00%
0/58 • From randomization until the end of the study, approximately up to 14 years
Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER