Trial Outcomes & Findings for Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies (NCT NCT03291379)
NCT ID: NCT03291379
Last Updated: 2021-07-19
Results Overview
Adverse events (AEs) related to treatment with BTG-002814 using the National Cancer Institute- Common Terminology Criteria for Adverse Events- Version 4.0 (NCI-CTCAE v4.0)
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Continuously throughout the study totalling 9 weeks
Results posted on
2021-07-19
Participant Flow
Participant milestones
| Measure |
BTG-002814
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies
Baseline characteristics by cohort
| Measure |
BTG-002814
n=8 Participants
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Age, Continuous
|
62.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=99 Participants
|
|
World Health Organisation (WHO) Performance Status
Grade 0 (asymptomatic)
|
8 Participants
n=99 Participants
|
|
World Health Organisation (WHO) Performance Status
Grade 1 (Symptomatic, but ambulatory)
|
0 Participants
n=99 Participants
|
|
World Health Organisation (WHO) Performance Status
Grade 2 (Symptomatic, <50% in bed)
|
0 Participants
n=99 Participants
|
|
Tumour type
Hepatocellular carcinoma (HCC)
|
2 Participants
n=99 Participants
|
|
Tumour type
Metastatic colorectal cancer (mCRC)
|
6 Participants
n=99 Participants
|
|
Number of liver lesions
|
1.6 Count
STANDARD_DEVIATION 1.4 • n=99 Participants
|
PRIMARY outcome
Timeframe: Continuously throughout the study totalling 9 weeksPopulation: Safety population - all participants treated with BTG-002814
Adverse events (AEs) related to treatment with BTG-002814 using the National Cancer Institute- Common Terminology Criteria for Adverse Events- Version 4.0 (NCI-CTCAE v4.0)
Outcome measures
| Measure |
BTG-002814
n=8 Participants
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
To Assess the Safety and Tolerability of Treatment With BTG-002814
participants with treatment emergent Adverse Events (AEs)
|
8 Participants
|
|
To Assess the Safety and Tolerability of Treatment With BTG-002814
participants with treatment emergent Serious Adverse Events (SAEs)
|
4 Participants
|
PRIMARY outcome
Timeframe: pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery)Population: all participants treated with BTG-002814
Pharmacokinetic (PK) analysis of participants plasma samples by liquid chromatography with tandem mass spectrometry at the following timepoints: pre-treatment, post treatment (2 hours, 4 hours, 24 hours), prior to surgery, and end of study to derive Cmax.
Outcome measures
| Measure |
BTG-002814
n=8 Participants
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
Vandetanib Plasma Cmax
|
24.3 ng/mL
Standard Deviation 13.94
|
|
Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
N-desmethyl Plasma Cmax
|
0.6 ng/mL
Standard Deviation 0.82
|
PRIMARY outcome
Timeframe: Following surgical resection of tumourPopulation: Results were not available for 2 patients where sample was incorrectly prepared, or no sample was received. For patients with multiple tumours, only the treated tumours were sampled and analysed. The results for this outcome measure are reported by individual subject (where data was available) by each sample location (centre, middle, edge of the tumour or 1cm away from tumour) per row.
PK analysis of participants resected liver tissue samples by liquid chromatography with tandem mass spectrometry to determine vandetanib concentrations at the centre, middle, and edge of the tumour, as well as in the normal tissue surrounding the tumour (1cm away).
Outcome measures
| Measure |
BTG-002814
n=6 Participants
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 01: Vandetanib concentration centre of tumour
|
404000 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 01: Vandetanib concentration middle of tumour
|
394000 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 01: Vandetanib concentration edge of tumour
|
327000 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 01: Vandetanib concentration 1cm away from tumour
|
10800 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 03: Vandetanib concentration centre of tumour
|
8510 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 03: Vandetanib concentration middle of tumour
|
11000 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 03: Vandetanib concentration edge of tumour
|
18800 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 03: Vandetanib concentration 1cm away from tumour
|
9120 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 05: Vandetanib concentration centre of tumour
|
7340 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 05: Vandetanib concentration middle of tumour
|
7550 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 05: Vandetanib concentration edge of tumour
|
12500 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 05: Vandetanib concentration 1cm away from tumour
|
7090 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 06: Vandetanib concentration centre of tumour
|
160000 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 06: Vandetanib concentration middle of tumour
|
151000 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 06: Vandetanib concentration edge of tumour
|
11100 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 06: Vandetanib concentration 1cm away from tumour
|
1480 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 07: Vandetanib concentration centre of tumour
|
4570 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 07: Vandetanib concentration middle of tumour
|
531 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 07: Vandetanib concentration edge of tumour
|
441 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 07: Vandetanib concentration 1cm away from tumour
|
2760 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08: Vandetanib concentration centre of tumour
|
1140 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (1cm lesion): whole tumour Vandetanib concentration
|
93500 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (inferior lesion): Vandetanib concentration centre of tumour
|
6180 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08: Vandetanib concentration middle of tumour
|
1240 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (inferior lesion): Vandetanib concentration middle of tumour
|
1440 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08: Vandetanib concentration edge of tumour
|
2840 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (inferior lesion): Vandetanib concentration edge of tumour
|
2710 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08: Vandetanib concentration 1cm away from tumour
|
29100 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (1 cm lesion): Vandetanib concentration 1cm away from tumour
|
5350 ng/mL
|
|
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (inferior lesion): Vandetanib concentration 1cm away from tumour
|
6010 ng/mL
|
PRIMARY outcome
Timeframe: pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery)Population: all participants treated with BTG-002814
PK analysis of participants plasma samples by liquid chromatography with tandem mass spectrometry at the following timepoints: pre-treatment, post treatment (2 hours, 4 hours, 24 hours), prior to surgery, and end of study to derive Tmax
Outcome measures
| Measure |
BTG-002814
n=8 Participants
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
Vandetanib Plasma Tmax
|
26.0 hours
Standard Deviation 67.08
|
|
Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
N-desmethyl Plasma Tmax
|
0.8 hours
Standard Deviation 1.04
|
PRIMARY outcome
Timeframe: pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery)Population: all participants treated with BTG-002814
PK analysis of participants plasma samples by liquid chromatography with tandem mass spectrometry at the following timepoints: pre-treatment, post treatment (2 hours, 4 hours, 24 hours), prior to surgery, and end of study to derive AUCEoS (area under the curve at end of study).
Outcome measures
| Measure |
BTG-002814
n=8 Participants
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814
Vandetanib Plasma AUCEoS
|
6979.3 ng*h/mL
Standard Deviation 3188.21
|
|
Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814
N-desmethyl Plasma AUCEoS
|
81.1 ng*h/mL
Standard Deviation 169.40
|
PRIMARY outcome
Timeframe: Following surgical resection of tumourPopulation: Results were not available for 2 patients where sample was incorrectly prepared, or no sample was received. For patients with multiple tumours, only the treated tumours were sampled and analysed. The results for this outcome measure are reported by individual subject (where data was available), by each sample location (centre, middle, edge of the tumour, 1cm away from tumour) per row.
PK analysis of participants resected liver tissue samples by liquid chromatography with tandem mass spectrometry to determine N-desmethyl vandetanib concentrations at the centre, middle, and edge of the tumour, as well as in the normal tissue surrounding the tumour (1cm away).
Outcome measures
| Measure |
BTG-002814
n=6 Participants
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration edge of tumour
|
171 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 01: N-desmethyl Vandetanib concentration centre of tumour
|
4620 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 01: N-desmethyl Vandetanib concentration middle of tumour
|
4740 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 01: N-desmethyl Vandetanib concentration edge of tumour
|
3680 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 01: N-desmethyl Vandetanib concentration 1cm away from tumour
|
280 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 03: N-desmethyl concentration centre of tumour
|
69.6 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 03: N-desmethyl Vandetanib concentration middle of tumour
|
59.8 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 03: N-desmethyl Vandetanib concentration edge of tumour
|
69.2 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 03: N-desmethyl Vandetanib concentration 1cm away from tumour
|
831 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 05: N-desmethyl concentration centre of tumour
|
421 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 05: N-desmethyl Vandetanib concentration middle of tumour
|
418 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 05: N-desmethyl Vandetanib concentration edge of tumour
|
469 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 05: N-desmethyl Vandetanib concentration 1cm away from tumour
|
544 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 06: N-desmethyl concentration centre of tumour
|
113 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 06: N-desmethyl Vandetanib concentration middle of tumour
|
93.9 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 06: N-desmethyl Vandetanib concentration edge of tumour
|
11.4 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 06: N-desmethyl Vandetanib concentration 1cm away from tumour
|
55.6 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 07: N-desmethyl concentration centre of tumour
|
21 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 07: N-desmethyl Vandetanib concentration middle of tumour
|
15.7 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 07: N-desmethyl Vandetanib concentration edge of tumour
|
28.7 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 07: N-desmethyl Vandetanib concentration 1cm away from tumour
|
84 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08: N-desmethyl concentration centre of tumour
|
39.3 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (1cm lesion): whole tumour N-desmethyl concentration
|
208 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (inferior lesion): N-desmethyl concentration centre of tumour
|
80.2 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08: N-desmethyl Vandetanib concentration middle of tumour
|
57.1 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration middle of tumour
|
101 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08: N-desmethyl Vandetanib concentration edge of tumour
|
145 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08: N-desmethyl Vandetanib concentration 1cm away from tumour
|
389 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (1 cm lesion): N-desmethyl Vandetanib concentration 1cm away from tumour
|
342 ng/mL
|
|
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration 1cm away from tumour
|
405 ng/mL
|
SECONDARY outcome
Timeframe: 1 day after treatmentPopulation: All 8 subjects treated with BTG-002814 were analysed, however, not all subjects have sampling of all regions (liver, registered sample, tumour, tumour dilated 1cm, tumour dilated 2cm) due to some samples not being able to be accurately processed and registered. The data for this outcome measure is reported by individual subject, for each sample region (where data is available) per row.
An automated thresholding and filtering algorithm was designed to allow the volume of delivered beads to be quantitatively determined for regions of interest (liver, registered sample, tumour, tumour dilated 1cm, tumour dilated 2cm) from the pre-surgical non-contrast CT scan and the PET/CT of the explanted liver samples following surgery.
Outcome measures
| Measure |
BTG-002814
n=8 Participants
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 02: Tumour
|
596.78 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 02: Tumour dilated 1cm
|
617.72 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 01: Liver
|
928.83 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 01: Registered sample
|
399.27 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 01: Tumour
|
361.14 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 01: tumour dilated 1cm
|
393.79 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 01: Tumour dilated 2cm
|
479.28 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 02: Liver
|
764.69 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 02: Tumour dilated 2cm
|
649.97 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 03: Liver
|
594.79 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 03: Registered sample
|
116.54 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 03: Tumour
|
0.32 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 03: Tumour dilated 1cm
|
36.26 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 03: Tumour dilated 2cm
|
108.85 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 04: Liver
|
852.03 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 05: Liver
|
849.29 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 05: Registered sample
|
751.62 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 05: Tumour
|
0 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 5: Tumour dilated 1cm
|
15.26 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 05: Tumour dilated 2cm
|
86.28 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 06: Liver
|
202.56 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 06: Registered sample
|
148.09 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 06: Tumour
|
51.14 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
ubject 06: Tumour dilated 1cm
|
115.39 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 06: Tumour dilated 2cm
|
166.80 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 07: Liver
|
720.78 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 07: Registered sample
|
103.82 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 07: Tumour
|
4.32 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 07: Tumour dilated 1cm
|
75.43 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 07: Tumour dilated 2cm
|
133.26 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 08: Liver
|
693.73 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 08: Registered sample
|
422.37 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 08: Tumour
|
21.87 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 08: Tumour dilated 1cm
|
264.90 µL
|
|
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Subject 08: Tumour dilated 2cm
|
378.15 µL
|
SECONDARY outcome
Timeframe: Post-surgery (tumour resection)Population: all participants treated with BTG-002814
An evaluation of histopathological features in both malignant and non-malignant liver tissue from the surgical specimen was performed by microscopic examination. Sections of resected liver tissue was paraffin-embedded and Hematoxylin and Eosin (H\&E) slides were produced. The H\&E slides were scanned to produce 3D pathology models of tumour volume and compared to the 3D models generated from clinical imaging. This allowed the extent of tumour necrosis and viable tumour to be determined.
Outcome measures
| Measure |
BTG-002814
n=8 Participants
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability
Tumour necrosis
|
92.5 percentage of surgical specimen
Interval 5.0 to 100.0
|
|
Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability
Viable tumour
|
7.5 percentage of surgical specimen
Interval 0.0 to 95.0
|
SECONDARY outcome
Timeframe: Post-surgery (tumour resection)An evaluation of histopathological features in both malignant and non-malignant liver tissue from the surgical specimen was performed by microscopic examination. Sections of resected liver tissue was paraffin-embedded and Hematoxylin and Eosin (H\&E) slides were produced. The H\&E slides were scanned to produce 3D pathology models of tumour volume and compared to the 3D models generated from clinical imaging. This allowed any vascular changes to be determined.
Outcome measures
| Measure |
BTG-002814
n=8 Participants
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes.
Vascular changes absent
|
8 Count of Participants
|
|
Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes.
Vascular changes present
|
0 Count of Participants
|
SECONDARY outcome
Timeframe: Baseline, pre-treatment, up to 3 days prior to surgical resection of tumourAfter acquisition of DCE-MRI liver sequences, tumour signal intensity curves were used to calculate tissue parameters describing tumour perfusion, blood flow and vascularity, before and following treatment with BTG 002814. Bland Altman analysis showed the variability between baseline and pre-treatment readings to be too high, so an interpretation of the changes in blood flow prior to surgery is unreliable.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, pre-treatment, 1 day after treatment, Up to 3 days prior to surgical resection, end of study (28-32 days post-surgery).The following serum biomarkers were measured at Baseline, pre-treatment, 1 day after treatment, Up to 3 days prior to surgical resection, end of study ; cytokines, chemokines and growth factors relevant to cancer and inflammation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, pre-treatment, Up to 3 days prior to surgical resection.The following tissue biomarkers were measured at Baseline, pre-treatment, Up to 3 days prior to surgical resection; Levels of serum alpha-fetoprotein (AFP) in patients with HCC. Levels of serum Carcinoembryonic Antigen (CEA), Cancer Antigen (CA)19-9 and CA-125 in patients with metastatic colorectal cancer (mCRC).
Outcome measures
Outcome data not reported
Adverse Events
BTG-002814
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BTG-002814
n=8 participants at risk
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Gastrointestinal disorders
Ileus
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Hepatobiliary disorders
Ascites
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Hepatobiliary disorders
Post procedural bile leak
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Infections and infestations
Lung infection
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Infections and infestations
Postoperative wound infection
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Renal and urinary disorders
Renal failure acute
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
Other adverse events
| Measure |
BTG-002814
n=8 participants at risk
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
|
|---|---|
|
Cardiac disorders
Bradycardia
|
37.5%
3/8 • Number of events 5 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Cardiac disorders
Cardiac signs and symptoms NEC
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Cardiac disorders
Sinus bradycardia
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
8/8 • Number of events 19 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Constipation
|
62.5%
5/8 • Number of events 6 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Dyspepsia
|
62.5%
5/8 • Number of events 8 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Gastritis
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • Number of events 8 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
General disorders
Fatigue
|
87.5%
7/8 • Number of events 23 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
General disorders
Non-cardiac chest pain
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
General disorders
Pain
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Infections and infestations
Lung infection
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Infections and infestations
Postoperative wound infection
|
25.0%
2/8 • Number of events 3 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Alanine aminotransferase
|
62.5%
5/8 • Number of events 8 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Aspartate aminotransferase
|
62.5%
5/8 • Number of events 7 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood albumin
|
37.5%
3/8 • Number of events 25 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood alkaline phosphatase
|
62.5%
5/8 • Number of events 5 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood bilirubin
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood calcium
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood creatinine
|
25.0%
2/8 • Number of events 7 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood glucose
|
62.5%
5/8 • Number of events 8 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood lactic acid
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood magnesium
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood sodium
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood thyroid stimulating hormone
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood urea
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Blood uric acid
|
50.0%
4/8 • Number of events 6 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
C-reactive protein
|
12.5%
1/8 • Number of events 14 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Electrocardiogram QT prolonged
|
25.0%
2/8 • Number of events 4 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Gamma-glutamyl transferase
|
62.5%
5/8 • Number of events 8 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Glomerular filtration rate
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Haemoglobin
|
100.0%
8/8 • Number of events 15 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
International normalized ratio
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Neutrophil count
|
12.5%
1/8 • Number of events 11 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Neutrophil count decreased
|
50.0%
4/8 • Number of events 6 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Platelet count
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
Weight decreased
|
37.5%
3/8 • Number of events 3 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Investigations
White blood cell count
|
25.0%
2/8 • Number of events 14 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
62.5%
5/8 • Number of events 7 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
12.5%
1/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Nervous system disorders
Paraesthesia
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Psychiatric disorders
Delirium
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
25.0%
2/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Vascular disorders
Haematoma
|
12.5%
1/8 • Number of events 2 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Vascular disorders
Hypertension
|
87.5%
7/8 • Number of events 12 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
|
Vascular disorders
Hypotension
|
37.5%
3/8 • Number of events 4 • From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60