Trial Outcomes & Findings for An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma (NCT NCT00597116)
NCT ID: NCT00597116
Last Updated: 2016-10-10
Results Overview
Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Assessed at 2 months.
Results posted on
2016-10-10
Participant Flow
First subject enrolled: 17 December 2007, Last subject last visit: 22 July 2009. The study was conducted at 2 centres in Switzerland and 4 centres in Germany.
Participant milestones
| Measure |
Vandetanib
Vandetanib 300 mg/day oral
|
Vinorelbine
Vinorelbine 30 mg/m2 iv, administrated weekly
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
Reasons for withdrawal
| Measure |
Vandetanib
Vandetanib 300 mg/day oral
|
Vinorelbine
Vinorelbine 30 mg/m2 iv, administrated weekly
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Progressive disease
|
11
|
6
|
Baseline Characteristics
An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma
Baseline characteristics by cohort
| Measure |
Vandetanib
n=13 Participants
Vandetanib 300 mg/day oral
|
Vinorelbine
n=10 Participants
Vinorelbine 30 mg/m2 iv, administrated weekly
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 Years
n=5 Participants
|
64 Years
n=7 Participants
|
65.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 2 months.Population: Only patients in the evaluable for efficacy population were included.It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles(unless progressive disease occurred at cycle 1)and who had at least one post-treatment tumour assessment.
Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.
Outcome measures
| Measure |
Vandetanib
n=12 Participants
Vandetanib 300 mg/day oral
|
Vinorelbine
n=10 Participants
Vinorelbine 30 mg/m2 iv, administrated weekly
|
|---|---|---|
|
Number of Participants With Disease Control.
|
0 Participants
Interval 0.0 to 0.0
|
5 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Assessed at 2 months.Population: Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.
Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart.
Outcome measures
| Measure |
Vandetanib
n=12 Participants
Vandetanib 300 mg/day oral
|
Vinorelbine
n=10 Participants
Vinorelbine 30 mg/m2 iv, administrated weekly
|
|---|---|---|
|
Number of Participants With Objective Response.
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Assessed from baseline to 12 months.Population: Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.
Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Vandetanib
n=12 Participants
Vandetanib 300 mg/day oral
|
Vinorelbine
n=10 Participants
Vinorelbine 30 mg/m2 iv, administrated weekly
|
|---|---|---|
|
Progression-free Survival (PFS)
|
1.8 Months
Interval 1.1 to 1.8
|
3.8 Months
Interval 2.1 to 7.3
|
SECONDARY outcome
Timeframe: Assessed from baseline to 12 months.Population: Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.
Outcome measures
| Measure |
Vandetanib
n=12 Participants
Vandetanib 300 mg/day oral
|
Vinorelbine
n=10 Participants
Vinorelbine 30 mg/m2 iv, administrated weekly
|
|---|---|---|
|
Overall Survival (OS)
|
7.8 Months
Interval 2.5 to 12.5
|
6.4 Months
Interval 3.6 to 14.9
|
Adverse Events
Vandetanib
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Vinorelbine
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vandetanib
n=13 participants at risk
Vandetanib 300 mg/day oral
|
Vinorelbine
n=10 participants at risk
Vinorelbine 30 mg/m2 iv, administrated weekly
|
|---|---|---|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Vascular disorders
Papilloedema
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Vascular disorders
Venous stasis
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Acute Abdomen
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Pyrexia
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Blood and lymphatic system disorders
Febrile Neutropoenia
|
15.4%
2/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Inguinal Hernia
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Deterioration Of General Health
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
Other adverse events
| Measure |
Vandetanib
n=13 participants at risk
Vandetanib 300 mg/day oral
|
Vinorelbine
n=10 participants at risk
Vinorelbine 30 mg/m2 iv, administrated weekly
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
30.0%
3/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
20.0%
2/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Nausea
|
30.8%
4/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
60.0%
6/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
30.0%
3/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
30.0%
3/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.4%
2/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Flatulence
|
15.4%
2/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Fatigue
|
38.5%
5/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
60.0%
6/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Chest Pain
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
30.0%
3/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
General Physical Health Deterioration
|
15.4%
2/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Asthenia
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Oedema
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Oedema Peripheral
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Orthostatic Intolerance
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Pain
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
General disorders
Pyrexia
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
30.0%
3/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Rhinitis
|
15.4%
2/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Infection
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Influenza
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Neutrophil Count Decreased
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
80.0%
8/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Weight Decreased
|
15.4%
2/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
30.0%
3/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
White Blood Cell Count Decreased
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
20.0%
2/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Blood Alkaline Phosphatase Increased
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Infections and infestations
Liver Function Test Abnormal
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Metabolism and nutrition disorders
Anorexia
|
53.8%
7/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
40.0%
4/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Insulin-Dependent
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
40.0%
4/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Psychiatric disorders
Depression
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Psychiatric disorders
Mental Disorder
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Psychiatric disorders
Sleep Disorder
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Renal and urinary disorders
Nocturia
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Renal and urinary disorders
Oliguria
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.1%
3/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
20.0%
2/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Skin and subcutaneous tissue disorders
Rash
|
46.2%
6/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Vascular disorders
Haematoma
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Vascular disorders
Hot Flush
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Vascular disorders
Hypertension
|
7.7%
1/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
0.00%
0/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/13
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
10.0%
1/10
The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)
|
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