Trial Outcomes & Findings for Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer (NCT NCT01876784)
NCT ID: NCT01876784
Last Updated: 2024-07-23
Results Overview
The PFS was defined as the time (in months) from randomization until the date of first documented disease progression or death (from any cause), whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) was defined as: at least a 20% increase and absolute increase of 5 mm in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Analysis was performed by Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
238 participants
Primary outcome timeframe
Randomization until disease progression or death, assessed every 12 weeks (up to 22 months)
Results posted on
2024-07-23
Participant Flow
The study was conducted at 60 active centers in 12 countries. A total of 299 participants were screened between 17 September 2013 and 26 September 2014, of which 238 participants were randomized. A total of 235 participants were treated in the study.
Participant milestones
| Measure |
Vandetanib/Vandetanib
Participants received Vandetanib 300 mg tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months). Participants who completed the randomized treatment period, were offered the opportunity to continue the same vandetanib treatment in the open label period, if, in the investigator's opinion, they received benefit and if the participant agreed and provided their informed consent to continue the open-label period for up to additional 31 months.
|
Placebo/Vandetanib
Participants received placebo matched to Vandetanib tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months). Participants who completed the randomized treatment period, and experienced disease progression were offered the option of treatment in open-label period with vandetanib, if in the investigator's opinion, such treatment was of clinical benefit to the participant, and if the participant agreed and provided their informed consent to begin open-label vandetanib treatment i.e., 300 mg tablet, orally once daily for up to 31 months.
|
|---|---|---|
|
Randomized Treatment Period (40 Months)
STARTED
|
119
|
119
|
|
Randomized Treatment Period (40 Months)
Treated
|
117
|
118
|
|
Randomized Treatment Period (40 Months)
COMPLETED
|
0
|
0
|
|
Randomized Treatment Period (40 Months)
NOT COMPLETED
|
119
|
119
|
|
Open-label Period (31 Months)
STARTED
|
23
|
74
|
|
Open-label Period (31 Months)
COMPLETED
|
0
|
0
|
|
Open-label Period (31 Months)
NOT COMPLETED
|
23
|
74
|
Reasons for withdrawal
| Measure |
Vandetanib/Vandetanib
Participants received Vandetanib 300 mg tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months). Participants who completed the randomized treatment period, were offered the opportunity to continue the same vandetanib treatment in the open label period, if, in the investigator's opinion, they received benefit and if the participant agreed and provided their informed consent to continue the open-label period for up to additional 31 months.
|
Placebo/Vandetanib
Participants received placebo matched to Vandetanib tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months). Participants who completed the randomized treatment period, and experienced disease progression were offered the option of treatment in open-label period with vandetanib, if in the investigator's opinion, such treatment was of clinical benefit to the participant, and if the participant agreed and provided their informed consent to begin open-label vandetanib treatment i.e., 300 mg tablet, orally once daily for up to 31 months.
|
|---|---|---|
|
Randomized Treatment Period (40 Months)
Withdrawal by Subject
|
20
|
4
|
|
Randomized Treatment Period (40 Months)
Adverse Event
|
22
|
5
|
|
Randomized Treatment Period (40 Months)
Protocol Violation
|
1
|
0
|
|
Randomized Treatment Period (40 Months)
Disease progression
|
43
|
81
|
|
Randomized Treatment Period (40 Months)
Lost to Follow-up
|
1
|
1
|
|
Randomized Treatment Period (40 Months)
Death
|
1
|
0
|
|
Randomized Treatment Period (40 Months)
Development of study-specific discontinuation criteria
|
5
|
2
|
|
Randomized Treatment Period (40 Months)
Randomized but not treated
|
2
|
1
|
|
Randomized Treatment Period (40 Months)
Other than specified above
|
24
|
25
|
|
Open-label Period (31 Months)
Withdrawal by Subject
|
6
|
8
|
|
Open-label Period (31 Months)
Adverse Event
|
2
|
6
|
|
Open-label Period (31 Months)
Protocol Violation
|
0
|
1
|
|
Open-label Period (31 Months)
Progressive disease
|
4
|
35
|
|
Open-label Period (31 Months)
Development of study-specific discontinuation criteria
|
1
|
5
|
|
Open-label Period (31 Months)
Lost to Follow-up
|
1
|
0
|
|
Open-label Period (31 Months)
Death
|
0
|
1
|
|
Open-label Period (31 Months)
Other than specified above
|
9
|
18
|
Baseline Characteristics
Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Vandetanib/Vandetanib
n=119 Participants
Participants received Vandetanib 300 mg tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months). Participants who completed the randomized treatment period, were offered the opportunity to continue the same vandetanib treatment in the open label period, if, in the investigator's opinion, they received benefit and if the participant agreed and provided their informed consent to continue the open-label period for up to additional 31 months.
|
Placebo/Vandetanib
n=119 Participants
Participants received placebo matched to Vandetanib tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months). Participants who completed the randomized treatment period, and experienced disease progression were offered the option of treatment in open-label period with vandetanib, if in the investigator's opinion, such treatment was of clinical benefit to the participant, and if the participant agreed and provided their informed consent to begin open-label vandetanib treatment i.e., 300 mg tablet, orally once daily for up to 31 months.
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 9.69 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 11.02 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization until disease progression or death, assessed every 12 weeks (up to 22 months)Population: Intent to treat population included all randomized participants.
The PFS was defined as the time (in months) from randomization until the date of first documented disease progression or death (from any cause), whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) was defined as: at least a 20% increase and absolute increase of 5 mm in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Randomized Treatment Period: Vandetanib
n=119 Participants
Vandetanib 300 mg tablet, orally once daily until disease progression or death.
|
Randomized Treatment Period: Placebo
n=119 Participants
Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
10.0 months
Interval 6.0 to 11.1
|
5.7 months
Interval 5.5 to 8.4
|
SECONDARY outcome
Timeframe: From randomization to the date of death due to any cause (maximum duration: up to 42 months)Population: Analysis was performed on intent-to-treat population.
OS was defined as the time from the date of randomization until death due to any cause. In the absence of observation of death, survival time was censored to last date the participant is known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Randomized Treatment Period: Vandetanib
n=119 Participants
Vandetanib 300 mg tablet, orally once daily until disease progression or death.
|
Randomized Treatment Period: Placebo
n=119 Participants
Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 31.6 to
Median and upper limit of 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events.
|
NA months
Interval 32.1 to
Median and upper limit of 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Analysis was performed on intent-to-treat population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Tumor size was the sum of the longest diameters of the target lesions. Target lesions were measurable tumor lesions. Baseline was defined as the last evaluable assessment prior to starting treatment.
Outcome measures
| Measure |
Randomized Treatment Period: Vandetanib
n=115 Participants
Vandetanib 300 mg tablet, orally once daily until disease progression or death.
|
Randomized Treatment Period: Placebo
n=116 Participants
Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
|
|---|---|---|
|
Randomized Treatment Period: Percent Change From Baseline in Tumor Size (TS) at Week 36
|
23.29 percent change
Standard Deviation 50.059
|
21.52 percent change
Standard Deviation 25.428
|
SECONDARY outcome
Timeframe: From randomization to the date of first documented tumor progression, or death due to any cause, whichever comes first (maximum duration: up to 42 months)Population: Analysis was performed on intent-to-treat population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Objective Response was defined as the percentage (%) of participants with complete response or partial response. Per RECIST 1.1 criteria, complete response was defined as the disappearance of all target lesions since Baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to less than (\<)10 millimeters (mm). Partial response was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum of diameters. Progressive Disease was defined as at least at least a 20% increase and absolute increase of 5 mm in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Randomized Treatment Period: Vandetanib
n=119 Participants
Vandetanib 300 mg tablet, orally once daily until disease progression or death.
|
Randomized Treatment Period: Placebo
n=118 Participants
Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
|
|---|---|---|
|
Percentage of Participants With Objective Response
|
5.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to the date of first assessment of worsening of pain (maximum duration: up to 42 months)Population: Analysis was performed on intent-to-treat population.
Time to worsening of pain was defined as the time interval from the date of randomization to the date of first assessment of worsening of pain with no evidence of improvement within the next 14 days. Participants rate their worst pain intensity during the past seven days using an 11-point NRS scale, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Higher scores indicated greater pain severity. TWP analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
Randomized Treatment Period: Vandetanib
n=119 Participants
Vandetanib 300 mg tablet, orally once daily until disease progression or death.
|
Randomized Treatment Period: Placebo
n=119 Participants
Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
|
|---|---|---|
|
Time to Worsening of Pain (TWP) Using Numeric Rating Scale (NRS) of Worst Pain
|
5.6 months
Interval 2.9 to 8.4
|
8.3 months
Interval 2.8 to 16.6
|
SECONDARY outcome
Timeframe: From the date of first response to the date of first documented tumor progression or death due to any cause whichever comes first (maximum duration: up to 42 months)Population: Analysis was performed on subset of participants with response. Here, '0' in 'overall number of participants' analyzed signifies that no participant in the Placebo/Vandetanib achieved any response, therefore DOR was not analyzed.
Duration of response was defined as the time from the date of first documented response until the date of documented progression or death. If participants did not progress following a response, then their DOR used the PFS censoring time. Per RECIST 1.1, progressive disease was defined as at least a 20% increase and absolute increase of 5 mm in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. DOR analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
Randomized Treatment Period: Vandetanib
n=6 Participants
Vandetanib 300 mg tablet, orally once daily until disease progression or death.
|
Randomized Treatment Period: Placebo
Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
|
|---|---|---|
|
Duration of Response (DOR)
|
NA months
Median, upper limit and lower limit of 95%CI was not estimable due to an insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Post-dose on Week 1 to Week 48Population: Number of participants analyzed= participants with available data for the time points.
Outcome measures
| Measure |
Randomized Treatment Period: Vandetanib
n=98 Participants
Vandetanib 300 mg tablet, orally once daily until disease progression or death.
|
Randomized Treatment Period: Placebo
Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
|
|---|---|---|
|
Randomized Treatment Period: PK Parameters: Maximum Plasma Concentration (Cmax)
Week 2
|
846.2 ng/ml
Standard Deviation 288.98
|
—
|
|
Randomized Treatment Period: PK Parameters: Maximum Plasma Concentration (Cmax)
Week 4
|
975.7 ng/ml
Standard Deviation 358.33
|
—
|
|
Randomized Treatment Period: PK Parameters: Maximum Plasma Concentration (Cmax)
Week 8
|
1043.1 ng/ml
Standard Deviation 395.08
|
—
|
|
Randomized Treatment Period: PK Parameters: Maximum Plasma Concentration (Cmax)
Week 12
|
1041.9 ng/ml
Standard Deviation 404.69
|
—
|
|
Randomized Treatment Period: PK Parameters: Maximum Plasma Concentration (Cmax)
Week 24
|
1004.9 ng/ml
Standard Deviation 408.34
|
—
|
|
Randomized Treatment Period: PK Parameters: Maximum Plasma Concentration (Cmax)
Week 36
|
904.1 ng/ml
Standard Deviation 312.51
|
—
|
|
Randomized Treatment Period: PK Parameters: Maximum Plasma Concentration (Cmax)
Week 48
|
963.0 ng/ml
Standard Deviation 452.4
|
—
|
|
Randomized Treatment Period: PK Parameters: Maximum Plasma Concentration (Cmax)
Week 1
|
695.1 ng/ml
Standard Deviation 238.94
|
—
|
Adverse Events
Randomized Treatment Period: Vandetanib
Serious events: 37 serious events
Other events: 111 other events
Deaths: 0 deaths
Randomized Treatment Period: Placebo
Serious events: 19 serious events
Other events: 87 other events
Deaths: 0 deaths
Open-Label Treatment Period: Vandetanib/Vandetanib
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Open-Label Treatment Period: Placebo/Vandetanib
Serious events: 24 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Treatment Period: Vandetanib
n=117 participants at risk
Participants received Vandetanib 300 mg tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months).
|
Randomized Treatment Period: Placebo
n=118 participants at risk
Participants received placebo matched to Vandetanib tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months).
|
Open-Label Treatment Period: Vandetanib/Vandetanib
n=23 participants at risk
Participants who completed the randomized treatment period, were offered the opportunity to continue the same vandetanib treatment in the open label period, if in the investigator's opinion, they received benefit and if the participant agreed and provided their informed consent to continue the open-label period for up to additional 31 months.
|
Open-Label Treatment Period: Placebo/Vandetanib
n=74 participants at risk
Participants who completed the randomized treatment period, and experienced disease progression were offered the option of treatment in open-label period with vandetanib, if, in the investigator's opinion, such treatment was of clinical benefit to the participant, and if the participant agreed and provided their informed consent to begin open-label vandetanib treatment i.e., 300 mg tablet, orally once daily for up to 31 months.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.7%
2/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Cardiac disorders
Atrial Flutter
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Cardiac disorders
Atrioventricular Block
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Cardiac disorders
Cardiac Arrest
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
3/117 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.7%
2/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
General disorders
Disease Progression
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.7%
2/74 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
General disorders
Impaired Healing
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
General disorders
Pyrexia
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Bronchitis
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Lung Abscess
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Lung Infection
|
1.7%
2/117 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Pneumonia
|
3.4%
4/117 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.7%
2/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Post Procedural Infection
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Sepsis
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.7%
2/74 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Urinary Tract Infection
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Injury, poisoning and procedural complications
Hypobarism
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Investigations
Troponin Increased
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Spinal Cord
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Lung
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Nervous system disorders
Dizziness
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Nervous system disorders
Generalised Tonic-Clonic Seizure
|
1.7%
2/117 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Nervous system disorders
Ivth Nerve Paresis
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Nervous system disorders
Ischaemic Stroke
|
1.7%
2/117 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Nervous system disorders
Somnolence
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.5%
3/118 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.7%
2/74 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.7%
2/74 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.85%
1/117 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.7%
2/117 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Bullous
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein Purpura
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson Syndrome
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Vascular disorders
Varicose Vein
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
Other adverse events
| Measure |
Randomized Treatment Period: Vandetanib
n=117 participants at risk
Participants received Vandetanib 300 mg tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months).
|
Randomized Treatment Period: Placebo
n=118 participants at risk
Participants received placebo matched to Vandetanib tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months).
|
Open-Label Treatment Period: Vandetanib/Vandetanib
n=23 participants at risk
Participants who completed the randomized treatment period, were offered the opportunity to continue the same vandetanib treatment in the open label period, if in the investigator's opinion, they received benefit and if the participant agreed and provided their informed consent to continue the open-label period for up to additional 31 months.
|
Open-Label Treatment Period: Placebo/Vandetanib
n=74 participants at risk
Participants who completed the randomized treatment period, and experienced disease progression were offered the option of treatment in open-label period with vandetanib, if, in the investigator's opinion, such treatment was of clinical benefit to the participant, and if the participant agreed and provided their informed consent to begin open-label vandetanib treatment i.e., 300 mg tablet, orally once daily for up to 31 months.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
6/117 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.1%
6/118 • Number of events 8 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Eye disorders
Cornea Verticillata
|
7.7%
9/117 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.8%
8/117 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
6.8%
8/118 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.1%
3/74 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.1%
6/117 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
3.4%
4/118 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.1%
6/74 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
9/117 • Number of events 11 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
9.3%
11/118 • Number of events 13 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.7%
2/23 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
65.8%
77/117 • Number of events 126 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
20.3%
24/118 • Number of events 29 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
13.0%
3/23 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
52.7%
39/74 • Number of events 58 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.1%
6/117 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.7%
2/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
6/117 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.5%
3/118 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.7%
2/74 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Nausea
|
18.8%
22/117 • Number of events 24 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
14.4%
17/118 • Number of events 21 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
21.6%
16/74 • Number of events 20 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Stomatitis
|
5.1%
6/117 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.5%
3/118 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
9/117 • Number of events 14 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
10.2%
12/118 • Number of events 15 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.1%
6/74 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
General disorders
Asthenia
|
17.9%
21/117 • Number of events 27 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
12.7%
15/118 • Number of events 15 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
9.5%
7/74 • Number of events 8 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
General disorders
Fatigue
|
11.1%
13/117 • Number of events 14 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
11.0%
13/118 • Number of events 13 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
18.9%
14/74 • Number of events 14 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
General disorders
Non-Cardiac Chest Pain
|
2.6%
3/117 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
6.8%
5/74 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
General disorders
Pyrexia
|
5.1%
6/117 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.5%
10/118 • Number of events 14 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.1%
6/74 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
5.1%
6/117 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.1%
3/74 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Conjunctivitis
|
0.85%
1/117 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
6.8%
5/74 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
8/117 • Number of events 10 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.9%
7/118 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.1%
3/74 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Paronychia
|
2.6%
3/117 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.3%
5/117 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.9%
7/118 • Number of events 8 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Infections and infestations
Urinary Tract Infection
|
9.4%
11/117 • Number of events 16 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.5%
3/118 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Investigations
Alanine Aminotransferase Increased
|
13.7%
16/117 • Number of events 23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
3.4%
4/118 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
16.2%
12/74 • Number of events 13 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.8%
15/117 • Number of events 21 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
3.4%
4/118 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
10.8%
8/74 • Number of events 10 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Investigations
Blood Creatinine Increased
|
6.0%
7/117 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.1%
6/74 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Investigations
Electrocardiogram Qt Prolonged
|
30.8%
36/117 • Number of events 55 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
3.4%
4/118 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
27.0%
20/74 • Number of events 36 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Investigations
Weight Decreased
|
8.5%
10/117 • Number of events 11 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.5%
3/118 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
9.5%
7/74 • Number of events 8 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
17.9%
21/117 • Number of events 23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.7%
2/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
20.3%
15/74 • Number of events 19 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.5%
17/117 • Number of events 18 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.5%
3/118 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.1%
6/74 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
9/117 • Number of events 11 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.2%
5/118 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
9.5%
7/74 • Number of events 11 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
9/117 • Number of events 19 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
7/117 • Number of events 11 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.2%
5/118 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.8%
8/117 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
10.2%
12/118 • Number of events 14 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.7%
2/23 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
6.8%
8/117 • Number of events 10 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
7.6%
9/118 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.1%
6/74 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/117 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.5%
10/118 • Number of events 11 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Nervous system disorders
Headache
|
13.7%
16/117 • Number of events 23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
7.6%
9/118 • Number of events 11 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
9.5%
7/74 • Number of events 10 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Psychiatric disorders
Anxiety
|
5.1%
6/117 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.2%
5/118 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Psychiatric disorders
Insomnia
|
12.8%
15/117 • Number of events 15 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.7%
2/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
13.5%
10/74 • Number of events 11 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Renal and urinary disorders
Haematuria
|
6.0%
7/117 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/74 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Renal and urinary disorders
Proteinuria
|
6.8%
8/117 • Number of events 8 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
6.8%
5/74 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
11/117 • Number of events 11 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
10.2%
12/118 • Number of events 16 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
16.2%
12/74 • Number of events 14 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.6%
3/117 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
3.4%
4/118 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
6.8%
5/74 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.0%
7/117 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.5%
10/118 • Number of events 10 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
9.5%
7/74 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.4%
4/117 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
6.8%
8/118 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.1%
3/74 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.6%
3/117 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.1%
6/118 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
2.7%
2/74 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
9/117 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.7%
2/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.1%
6/74 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.1%
6/117 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.7%
2/118 • Number of events 3 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.4%
1/74 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
11.1%
13/117 • Number of events 14 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.7%
2/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.1%
6/74 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
15.4%
18/117 • Number of events 18 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.1%
6/118 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.3%
5/117 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
1.7%
2/118 • Number of events 2 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.1%
6/74 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
5.1%
6/117 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
6.8%
5/74 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
12.0%
14/117 • Number of events 15 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/118 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.4%
4/74 • Number of events 4 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
6/117 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.2%
5/118 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.3%
1/23 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
8.1%
6/74 • Number of events 6 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.8%
36/117 • Number of events 51 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
5.1%
6/118 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
25.7%
19/74 • Number of events 24 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
6.0%
7/117 • Number of events 7 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.85%
1/118 • Number of events 1 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
4.1%
3/74 • Number of events 5 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
|
Vascular disorders
Hypertension
|
41.0%
48/117 • Number of events 53 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
7.6%
9/118 • Number of events 9 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
0.00%
0/23 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for open label period of the study.
|
41.9%
31/74 • Number of events 35 • The data for non-serious adverse events are presented until the Last Participant Last Visit (LPLV) date i.e., 19 June 2017, up to 3 years and 9 months. Serious adverse events were collected until the end of the study, up to 8 years and 4 months.
Analysis was performed for safety population i.e., participants who received at least one dose of treatment. For participants who continued Vandetanib after the LPLV because they still benefited of it per investigator judgment, Serious adverse events were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for 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