Trial Outcomes & Findings for Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer (NCT NCT00659438)
NCT ID: NCT00659438
Last Updated: 2016-12-05
Results Overview
To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set). PSA progression free rate defined as the number of participants with : * After decline from baseline: a 25% increase above the nadir * No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
4 months
Results posted on
2016-12-05
Participant Flow
From February 4th, 2008 to April 26th, 2010, 8 centers in France.
110 participants screened; 95 participants were randomized to receive either bicalutamide 150 mg + vandetanib 300 mg once daily oral dose or bicalutamide 150 mg + placebo.
Participant milestones
| Measure |
Vandetanib
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
Bicalutamide 150mg + placebo
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
Assessable Set : Primary Analysis
|
44
|
45
|
|
Overall Study
Secondary Analysis Set
|
47
|
48
|
|
Overall Study
Safety Analysis Set
|
48
|
47
|
|
Overall Study
COMPLETED
|
33
|
40
|
|
Overall Study
NOT COMPLETED
|
14
|
8
|
Reasons for withdrawal
| Measure |
Vandetanib
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
Bicalutamide 150mg + placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Death
|
11
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Vandetanib
n=47 Participants
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
n=48 Participants
Bicalutamide 150mg + placebo
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.77 years
STANDARD_DEVIATION 7.68 • n=93 Participants
|
72.23 years
STANDARD_DEVIATION 6.92 • n=4 Participants
|
71.51 years
STANDARD_DEVIATION 7.30 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
95 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 4 monthsTo assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set). PSA progression free rate defined as the number of participants with : * After decline from baseline: a 25% increase above the nadir * No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)
Outcome measures
| Measure |
Vandetanib
n=44 Participants
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
n=45 Participants
Bicalutamide 150mg + placebo
|
|---|---|---|
|
Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 4 monthsDue to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to PSA progression was not evaluated. PFS was evaluated instead, whether biological or clinical progression.
Outcome measures
| Measure |
Vandetanib
n=47 Participants
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
n=48 Participants
Bicalutamide 150mg + placebo
|
|---|---|---|
|
Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression)
|
12.2 weeks
Interval 11.8 to 12.4
|
12.8 weeks
Interval 12.2 to 13.6
|
SECONDARY outcome
Timeframe: 4 monthsDue to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to onset of cancer-related symptoms was not evaluated. PFS was evaluated instead, whether biological or clinical progression.
Outcome measures
| Measure |
Vandetanib
n=47 Participants
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
n=48 Participants
Bicalutamide 150mg + placebo
|
|---|---|---|
|
Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms)
|
12.2 weeks
Interval 11.8 to 12.4
|
12.8 weeks
Interval 12.2 to 13.6
|
SECONDARY outcome
Timeframe: 4 monthsTo investigate the effect of vandetanib on the PSA response rate. PSA response rate defined by the number of participants with a PSA decrease relative to baseline of at least 50%. A minimum decrease of 2 ng/mL in absolute value and a confirmation on at least 2 consecutive occasions (at least 4 weeks apart) were requested.
Outcome measures
| Measure |
Vandetanib
n=47 Participants
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
n=48 Participants
Bicalutamide 150mg + placebo
|
|---|---|---|
|
PSA Response Rate
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: End of study (July 2011)To investigate the effect of vandetanib on overall survival. Patients alive at the time of the statistical analysis were censored at the time they were last known to be alive. Due to censored data, median overall survival in the placebo group cannot be calculated. OS defined as the number of participants who were alive.
Outcome measures
| Measure |
Vandetanib
n=47 Participants
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
n=48 Participants
Bicalutamide 150mg + placebo
|
|---|---|---|
|
Overall Survival (OS)
|
32 participants
Interval 24.2 to
|
35 participants
|
SECONDARY outcome
Timeframe: 4 monthsTo describe the effect of vandetanib on progression rate from the radionuclide bone scanning in a sub-group of patients who had a bone scan within 3 to 6 months after 1st treatment dose. Number of participants with at least 2 new lesions on the radionuclide bone scan compared to baseline assessment were counted for calculation of progression rate.
Outcome measures
| Measure |
Vandetanib
n=10 Participants
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
n=13 Participants
Bicalutamide 150mg + placebo
|
|---|---|---|
|
Progression Rate From the Radionuclide Bone Scanning
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed.
To investigate the effect of vandetanib on CTC. Numbering of CTCs to be performed at baseline, 1 week, 1 and 2 months after randomisation. This study was proposed only to patients followed in a study centre located in Ile de France. Correlation between the number of CTCs and PSA response was to be estimated after 1 week, 1 and 2 months of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPopulation: This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed.
To investigate the effect of vandetanib on CEC. Numbering of CECs was to be performed at baseline, 1 week, 1 month and 2 months after randomisation. Correlation between the number of CECs and PSA response was to be estimated after 1 week, 1 month and 2 months of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsTo investigate the relationship between response to vandetanib, CTCs and CECs. To investigate gene signature profile of antiangiogenic response by gene micro-array analysis of CTCs. Gene signature profile of CTCs was aimed to be compared before and after 2 months of treatment. No blood sample has been taken for the study, and so results on CTCs, CECs of tumour vessels and gene and signature profiles of CTCs were not performed.
Outcome measures
Outcome data not reported
Adverse Events
Vandetanib
Serious events: 17 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vandetanib
n=48 participants at risk
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
n=47 participants at risk
Bicalutamide 150mg + placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Infections and infestations
Sepsis
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Gastrointestinal disorders
Anal fissure
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Infections and infestations
Bronchopneumonia
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Infections and infestations
Pneumonia
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
General disorders
Death
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Nervous system disorders
Cerebrovascular accident
|
4.2%
2/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Gastrointestinal disorders
Ileus
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Infections and infestations
Septic shock
|
0.00%
0/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
4.2%
2/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Cardiac disorders
Torsade de pointes
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Vascular disorders
Hypertension
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Investigations
Electrocardiogram QT prolonged
|
4.2%
2/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Vascular disorders
Hypertensive crisis
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Cardiac disorders
Ventricular extrasystoles
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Surgical and medical procedures
Stent placement
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
General disorders
Disease progression
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
General disorders
Performance status decrease
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
Other adverse events
| Measure |
Vandetanib
n=48 participants at risk
Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
|
Placebo
n=47 participants at risk
Bicalutamide 150mg + placebo
|
|---|---|---|
|
General disorders
Fatigue
|
4.2%
2/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
6.4%
3/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
General disorders
Asthenia
|
41.7%
20/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
40.4%
19/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
43.8%
21/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
10.6%
5/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
8/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
17.0%
8/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Gastrointestinal disorders
Nausea
|
18.8%
9/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.6%
7/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
12.8%
6/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
3/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
14.9%
7/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
3/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
10.6%
5/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Vascular disorders
Hot flush
|
22.9%
11/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
23.4%
11/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Vascular disorders
Hypertension
|
29.2%
14/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
10.6%
5/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Nervous system disorders
Dizziness
|
10.4%
5/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
10.6%
5/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Psychiatric disorders
Insomnia
|
8.3%
4/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
12.8%
6/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Psychiatric disorders
Anxiety
|
4.2%
2/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
14.9%
7/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
10.4%
5/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Investigations
Electrocardiogram QT prolonged
|
16.7%
8/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Investigations
Weight decreased
|
10.4%
5/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
14.6%
7/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
8.5%
4/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
General disorders
Chest pain
|
0.00%
0/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
6.4%
3/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
General disorders
Pain
|
0.00%
0/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
6.4%
3/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
4/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
6.4%
3/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
3/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
2/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
8.5%
4/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.2%
2/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
6.4%
3/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
8.5%
4/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Infections and infestations
Urinary tra ct infection
|
8.3%
4/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Infections and infestations
Rhinitis
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
6.4%
3/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Nervous system disorders
Headache
|
6.2%
3/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
8.5%
4/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Nervous system disorders
Sciatica
|
6.2%
3/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Psychiatric disorders
Depression
|
8.3%
4/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.3%
4/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
4/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
4/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
3/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
6.2%
3/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.2%
3/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
4/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
4.3%
2/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
3/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
2.1%
1/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Renal and urinary disorders
Haematuria
|
4.2%
2/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
6.4%
3/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Renal and urinary disorders
Pollakiuria
|
4.2%
2/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
6.4%
3/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Renal and urinary disorders
Dysuria
|
2.1%
1/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
6.4%
3/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
8.3%
4/48
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
0.00%
0/47
Safety analysis set is composed with all randomized subjects who received at least one dose of treatment. One patient mistakenly received vandetanib during 3 days while randomized to placebo. This patient was accounted in the vandetanib group in the safety population. So, safety analysis set is composed with 48 Vandetanib and 47 placebo patients.
|
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