Trial Outcomes & Findings for Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients (NCT NCT00418886)
NCT ID: NCT00418886
Last Updated: 2024-12-31
Results Overview
Median time (in weeks) from randomization until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
698 participants
Primary outcome timeframe
RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Results posted on
2024-12-31
Participant Flow
First participant enrolled 09 January 2007, last participant enrolled 29 February 2008, cut off date 05 September 2008.
A total of 534 participants were randomized in the study.
Participant milestones
| Measure |
Vandetanib Plus Pemetrexed
Vandetanib \[100 milligram (mg) daily\] plus pemetrexed \[500 mg/meter square (m\^2) given on Day 1 of each 21-day cycle\].
|
Placebo Plus Pemetrexed
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Randomized Period
STARTED
|
256
|
278
|
|
Randomized Period
Treated
|
260
|
273
|
|
Randomized Period
COMPLETED
|
30
|
23
|
|
Randomized Period
NOT COMPLETED
|
226
|
255
|
|
Survival Follow-up Period
STARTED
|
120
|
114
|
|
Survival Follow-up Period
Treated With Vandetanib
|
124
|
110
|
|
Survival Follow-up Period
COMPLETED
|
120
|
114
|
|
Survival Follow-up Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Vandetanib Plus Pemetrexed
Vandetanib \[100 milligram (mg) daily\] plus pemetrexed \[500 mg/meter square (m\^2) given on Day 1 of each 21-day cycle\].
|
Placebo Plus Pemetrexed
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Randomized Period
discontinue treatment survival follow-up
|
90
|
91
|
|
Randomized Period
Death
|
122
|
147
|
|
Randomized Period
Withdrawal by Subject
|
9
|
10
|
|
Randomized Period
Lost to Follow-up
|
4
|
6
|
|
Randomized Period
withdrawn due to other reason
|
1
|
0
|
|
Randomized Period
randomised but no treatment received
|
0
|
1
|
Baseline Characteristics
Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients
Baseline characteristics by cohort
| Measure |
Vandetanib Plus Pemetrexed
n=256 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=278 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Total
n=534 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
97 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
159 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progressionPopulation: The full analysis set included all randomized participants.
Median time (in weeks) from randomization until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.
Outcome measures
| Measure |
Vandetanib Plus Pemetrexed
n=256 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=278 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Progression-Free Survival (PFS) in the Overall Population
|
17.6 weeks
Interval 13.4 to 18.9
|
11.9 weeks
Interval 11.4 to 15.9
|
PRIMARY outcome
Timeframe: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progressionPopulation: The female analysis set included all randomized female participants.
Median time (in weeks) from randomization until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.
Outcome measures
| Measure |
Vandetanib Plus Pemetrexed
n=97 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=107 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Progression-Free Survival in the Female Population
|
17.9 weeks
Interval 14.7 to 22.7
|
13.0 weeks
Interval 11.1 to 17.7
|
SECONDARY outcome
Timeframe: Time to death in monthsPopulation: The full analysis set included all randomized participants.
The OS is defined as the time from date of randomization until death. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive (i.e, their status must be known at the censored date and should not be lost to follow up or unknown).
Outcome measures
| Measure |
Vandetanib Plus Pemetrexed
n=256 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=278 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Overall Survival (OS)
|
10.5 months
Interval 8.9 to 12.3
|
9.2 months
Interval 7.1 to 12.0
|
SECONDARY outcome
Timeframe: Each participant was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progressionPopulation: The full analysis set included all randomized participants.
The ORR is the number of participants that are responders i.e, those participants with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)\>= 6 weeks, progressive disease (PD) or NE.
Outcome measures
| Measure |
Vandetanib Plus Pemetrexed
n=256 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=278 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Objective Response Rate (ORR)
|
19.1 percentage of participants
|
7.9 percentage of participants
|
SECONDARY outcome
Timeframe: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progressionPopulation: The full analysis set included all randomized participants.
The DCR is defined as the number of patients who achieved disease control at 6 weeks following randomization. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \>= 6 weeks.
Outcome measures
| Measure |
Vandetanib Plus Pemetrexed
n=256 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=278 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Disease Control Rate (DCR)
|
56.6 percentage of participants
|
45.7 percentage of participants
|
SECONDARY outcome
Timeframe: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progressionPopulation: The full analysis set included all randomized participants. Only participants with response are analyzed for this outcome measure.
Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment).
Outcome measures
| Measure |
Vandetanib Plus Pemetrexed
n=49 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=22 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Duration of Response (DoR)
|
24.1 weeks
Interval 17.4 to 30.0
|
24.4 weeks
Interval 18.0 to 32.0
|
SECONDARY outcome
Timeframe: LCSS questionnaires are to be administered every 3 weeks after randomizationPopulation: The full analysis set included all randomized participants.
TDS is the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days. The LCSS scale measures changes in symptoms associated with lung cancer.
Outcome measures
| Measure |
Vandetanib Plus Pemetrexed
n=256 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=278 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Time to Deterioration of Disease-Related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score
|
18.1 weeks
Interval 15.1 to 23.6
|
12.1 weeks
Interval 9.7 to 17.3
|
SECONDARY outcome
Timeframe: ASBI is a score taken from the LCSS questionnaires which are to be administered every 3 weeks after randomizationPopulation: The full analysis set included all randomized participants.
Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days. The ASBI is derived from 6 of LCSS's 9 items.
Outcome measures
| Measure |
Vandetanib Plus Pemetrexed
n=256 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=278 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Time to Deterioration of Disease-Related Symptoms by Average Symptom Burden Index (ASBI) Score
|
16.0 weeks
Interval 14.0 to 20.3
|
13.4 weeks
Interval 10.3 to 17.9
|
SECONDARY outcome
Timeframe: LCSS questionnaires are to be administered every 3 weeks after randomizationPopulation: The full analysis set included all randomized participants.
The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. LCSS total score is an average of all 9 visual analogue participant scales from "none" \[0 millimeter (mm)\] to "as much as it could be" (100 mm).
Outcome measures
| Measure |
Vandetanib Plus Pemetrexed
n=256 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=278 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Longitudinal Analysis of Lung Cancer Symptom Scale Total Score
|
25.7 mms on a visual analogue scale
Standard Error 2.85
|
28.3 mms on a visual analogue scale
Standard Error 2.77
|
SECONDARY outcome
Timeframe: ASBI is a score taken from the LCSS questionnaires administered every 3 weeks after randomizationPopulation: The full analysis set included all randomized participants.
The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. ASBI is an average of the 6 symptom visual analogue patient scales from "none" (0 mm) to "as much as it could be" (100 mm).
Outcome measures
| Measure |
Vandetanib Plus Pemetrexed
n=256 Participants
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
Placebo Plus Pemetrexed
n=278 Participants
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle).
|
|---|---|---|
|
Longitudinal Analysis of Average Symptom Burden Index Score
|
21.7 mms on a visual analogue scale
Standard Error 2.75
|
24.3 mms on a visual analogue scale
Standard Error 2.67
|
Adverse Events
Randomized Period: Vandetanib Plus Pemetrexed
Serious events: 84 serious events
Other events: 234 other events
Deaths: 122 deaths
Randomized Period: Placebo Plus Pemetrexed
Serious events: 94 serious events
Other events: 242 other events
Deaths: 147 deaths
Survival Follow-up Period: Vandetanib Plus Pemetrexed
Serious events: 7 serious events
Other events: 22 other events
Deaths: 63 deaths
Survival Follow-up Period: Placebo Plus Pemetrexed
Serious events: 3 serious events
Other events: 19 other events
Deaths: 58 deaths
Serious adverse events
| Measure |
Randomized Period: Vandetanib Plus Pemetrexed
n=260 participants at risk
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle) in randomized period.
|
Randomized Period: Placebo Plus Pemetrexed
n=273 participants at risk
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle) in randomized period.
|
Survival Follow-up Period: Vandetanib Plus Pemetrexed
n=124 participants at risk
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle) in survival follow-up period.
|
Survival Follow-up Period: Placebo Plus Pemetrexed
n=110 participants at risk
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle) in survival follow-up period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.6%
7/273 • Number of events 8 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.2%
3/260 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.5%
4/273 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.8%
5/273 • Number of events 5 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
3/260 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.5%
4/273 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Atrial Flutter
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Cardiac Failure
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Myocardial Infarction
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Cardiac disorders
Tachycardia
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Eye disorders
Retinal Detachment
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Constipation
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer Haemorrhage
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Melaena
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Nausea
|
0.77%
2/260 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.5%
4/273 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Stomatitis
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
3/260 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.2%
6/273 • Number of events 8 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Asthenia
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Chills
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Death
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Disease Progression
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Fatigue
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.2%
6/273 • Number of events 6 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Gait Disturbance
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
General Physical Health Deterioration
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Organ Failure
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Performance Status Decreased
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Pyrexia
|
2.7%
7/260 • Number of events 9 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.1%
3/273 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Hepatobiliary disorders
Jaundice
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Bacterial Infection
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Bronchopneumonia
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Infection
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Lobar Pneumonia
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.5%
4/260 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Pneumonia
|
2.7%
7/260 • Number of events 7 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
3.7%
10/273 • Number of events 13 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Sepsis
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Urinary Tract Infection
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Injury, poisoning and procedural complications
Anaesthetic Complication Cardiac
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Investigations
Body Temperature Increased
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Investigations
Neutrophil Count Decreased
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.2%
3/260 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.1%
3/273 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Pain
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Cerebral Artery Embolism
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.2%
3/260 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Dizziness
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Migraine
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Monoparesis
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Syncope
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Renal and urinary disorders
Acute Prerenal Failure
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Renal and urinary disorders
Renal Failure
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Renal and urinary disorders
Renal Impairment
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis Allergic
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
8/260 • Number of events 10 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
3.7%
10/273 • Number of events 10 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.1%
3/273 • Number of events 5 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.2%
3/260 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.5%
4/273 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.1%
3/273 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.2%
3/260 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.2%
6/273 • Number of events 6 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fistula
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.2%
3/260 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.77%
2/260 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.73%
2/273 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Vascular disorders
Hypertension
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/260 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.37%
1/273 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.38%
1/260 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/273 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
Other adverse events
| Measure |
Randomized Period: Vandetanib Plus Pemetrexed
n=260 participants at risk
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle) in randomized period.
|
Randomized Period: Placebo Plus Pemetrexed
n=273 participants at risk
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle) in randomized period.
|
Survival Follow-up Period: Vandetanib Plus Pemetrexed
n=124 participants at risk
Vandetanib (100 mg daily) plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle) in survival follow-up period.
|
Survival Follow-up Period: Placebo Plus Pemetrexed
n=110 participants at risk
Placebo plus pemetrexed (500 mg/m\^2 given on Day 1 of each 21-day cycle) in survival follow-up period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
19/260 • Number of events 27 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
19.8%
54/273 • Number of events 59 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.9%
18/260 • Number of events 27 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
6.2%
17/273 • Number of events 22 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.1%
21/260 • Number of events 32 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
9.5%
26/273 • Number of events 35 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Eye disorders
Lacrimation Increased
|
4.6%
12/260 • Number of events 12 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
5.1%
14/273 • Number of events 16 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
16/260 • Number of events 21 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
5.5%
15/273 • Number of events 17 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.8%
2/110 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.4%
14/260 • Number of events 16 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
6.2%
17/273 • Number of events 18 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
52/260 • Number of events 69 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
19.4%
53/273 • Number of events 65 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.4%
3/124 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.4%
66/260 • Number of events 95 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
17.6%
48/273 • Number of events 66 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.4%
3/124 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.8%
2/110 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.1%
21/260 • Number of events 25 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
4.0%
11/273 • Number of events 11 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Nausea
|
28.1%
73/260 • Number of events 100 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
35.9%
98/273 • Number of events 167 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.7%
3/110 • Number of events 12 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Stomatitis
|
7.3%
19/260 • Number of events 25 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
6.6%
18/273 • Number of events 24 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Gastrointestinal disorders
Vomiting
|
14.2%
37/260 • Number of events 42 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
20.1%
55/273 • Number of events 97 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.4%
3/124 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.7%
3/110 • Number of events 10 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Asthenia
|
11.2%
29/260 • Number of events 34 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
15.8%
43/273 • Number of events 63 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
3.2%
4/124 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.8%
2/110 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Fatigue
|
38.1%
99/260 • Number of events 127 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
43.2%
118/273 • Number of events 159 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.6%
2/124 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.8%
2/110 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Oedema Peripheral
|
4.2%
11/260 • Number of events 12 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
8.1%
22/273 • Number of events 24 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
General disorders
Pyrexia
|
9.6%
25/260 • Number of events 32 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
15.8%
43/273 • Number of events 60 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.6%
2/124 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.6%
12/260 • Number of events 14 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
5.1%
14/273 • Number of events 19 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Investigations
Weight Decreased
|
8.8%
23/260 • Number of events 23 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
5.5%
15/273 • Number of events 15 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Metabolism and nutrition disorders
Anorexia
|
21.5%
56/260 • Number of events 72 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
23.8%
65/273 • Number of events 82 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.4%
3/124 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
9/260 • Number of events 10 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
5.9%
16/273 • Number of events 17 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.6%
2/124 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.7%
3/110 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.2%
24/260 • Number of events 25 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
11.4%
31/273 • Number of events 32 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.8%
2/110 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
6.9%
18/260 • Number of events 21 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
7.7%
21/273 • Number of events 26 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.6%
2/124 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.7%
3/110 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
4.2%
11/260 • Number of events 12 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
8.4%
23/273 • Number of events 25 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.0%
13/260 • Number of events 13 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
6.6%
18/273 • Number of events 18 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
3.6%
4/110 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
5.4%
14/260 • Number of events 18 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
7.7%
21/273 • Number of events 24 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Dizziness
|
7.7%
20/260 • Number of events 26 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
8.4%
23/273 • Number of events 30 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
3.6%
4/110 • Number of events 5 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Nervous system disorders
Headache
|
10.8%
28/260 • Number of events 35 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
14.7%
40/273 • Number of events 50 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.7%
3/110 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Psychiatric disorders
Anxiety
|
4.2%
11/260 • Number of events 12 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
5.9%
16/273 • Number of events 16 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Psychiatric disorders
Depression
|
5.4%
14/260 • Number of events 14 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
6.2%
17/273 • Number of events 17 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Psychiatric disorders
Insomnia
|
13.1%
34/260 • Number of events 38 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
9.9%
27/273 • Number of events 27 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.4%
66/260 • Number of events 75 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
21.6%
59/273 • Number of events 68 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
3.2%
4/124 • Number of events 4 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.7%
3/110 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.9%
18/260 • Number of events 18 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.2%
6/273 • Number of events 6 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.8%
49/260 • Number of events 53 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
20.5%
56/273 • Number of events 60 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.6%
2/124 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.5%
17/260 • Number of events 22 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
4.4%
12/273 • Number of events 15 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.6%
12/260 • Number of events 14 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
6.2%
17/273 • Number of events 21 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 3 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.4%
14/260 • Number of events 15 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.9%
8/273 • Number of events 8 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.4%
14/260 • Number of events 14 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.9%
8/273 • Number of events 9 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.6%
2/124 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.4%
14/260 • Number of events 18 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
4.4%
12/273 • Number of events 16 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.81%
1/124 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/110 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.8%
28/260 • Number of events 37 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
14.7%
40/273 • Number of events 47 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.00%
0/124 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
38.1%
99/260 • Number of events 143 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
26.0%
71/273 • Number of events 93 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.4%
3/124 • Number of events 5 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
|
Vascular disorders
Hypertension
|
11.2%
29/260 • Number of events 35 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
2.9%
8/273 • Number of events 9 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
1.6%
2/124 • Number of events 2 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
0.91%
1/110 • Number of events 1 • From the date of informed consent up to the study completion for each participant, approximately 193 months.
The Safety analysis set included all participants who received at least 1 dose of vandetanib or placebo. Four participants randomized to the "Placebo Plus Pemetrexed" reporting group were erroneously assigned to receive vandetanib during the Randomized Period. Therefore, the total number of participants received the Vandetanib Plus pemetrexed treatment was 260 whereas the total participants received "Placebo Plus Pemetrexed" were 273 during the Randomized Period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER