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Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies (VEROnA)

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ClinicalTrials.gov Identifier: NCT03291379
Recruitment Status : Completed
First Posted : September 25, 2017
Results First Posted : February 3, 2021
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Biocompatibles UK Ltd

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Hepatocellular
Metastatic Colorectal Cancer
Intervention Drug: BTG-002814
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BTG-002814
Hide Arm/Group Description

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title BTG-002814
Hide Arm/Group Description

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
62.5
(50 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
7
  87.5%
More than one race
0
   0.0%
Unknown or Not Reported
1
  12.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 8 participants
8
World Health Organisation (WHO) Performance Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Grade 0 (asymptomatic)
8
 100.0%
Grade 1 (Symptomatic, but ambulatory)
0
   0.0%
Grade 2 (Symptomatic, <50% in bed)
0
   0.0%
Tumour type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hepatocellular carcinoma (HCC)
2
  25.0%
Metastatic colorectal cancer (mCRC)
6
  75.0%
[1]
Measure Description: Participants must have resectable Hepatocellular carcinoma (HCC) (Child Pugh A, international normalized ratio (INR) ≤1.5) or resectable liver metastases from colorectal cancer (CRC) and be a candidate for liver surgery
Number of liver lesions  
Mean (Standard Deviation)
Unit of measure:  Count
Number Analyzed 8 participants
1.6  (1.4)
1.Primary Outcome
Title To Assess the Safety and Tolerability of Treatment With BTG-002814
Hide Description 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)
Time Frame Continuously throughout the study totalling 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population - all participants treated with BTG-002814
Arm/Group Title BTG-002814
Hide Arm/Group Description:

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
participants with treatment emergent Adverse Events (AEs)
8
 100.0%
participants with treatment emergent Serious Adverse Events (SAEs)
4
  50.0%
2.Primary Outcome
Title Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
all participants treated with BTG-002814
Arm/Group Title BTG-002814
Hide Arm/Group Description:

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
Vandetanib Plasma Cmax 24.3  (13.94)
N-desmethyl Plasma Cmax 0.6  (0.82)
3.Primary Outcome
Title Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Hide Description 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).
Time Frame Following surgical resection of tumour
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title BTG-002814
Hide Arm/Group Description:

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: ng/mL
Subject 01: Vandetanib concentration centre of tumour Number Analyzed 1 participants
404000
Subject 01: Vandetanib concentration middle of tumour Number Analyzed 1 participants
394000
Subject 01: Vandetanib concentration edge of tumour Number Analyzed 1 participants
327000
Subject 01: Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
10800
Subject 03: Vandetanib concentration centre of tumour Number Analyzed 1 participants
8510
Subject 03: Vandetanib concentration middle of tumour Number Analyzed 1 participants
11000
Subject 03: Vandetanib concentration edge of tumour Number Analyzed 1 participants
18800
Subject 03: Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
9120
Subject 05: Vandetanib concentration centre of tumour Number Analyzed 1 participants
7340
Subject 05: Vandetanib concentration middle of tumour Number Analyzed 1 participants
7550
Subject 05: Vandetanib concentration edge of tumour Number Analyzed 1 participants
12500
Subject 05: Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
7090
Subject 06: Vandetanib concentration centre of tumour Number Analyzed 1 participants
160000
Subject 06: Vandetanib concentration middle of tumour Number Analyzed 1 participants
151000
Subject 06: Vandetanib concentration edge of tumour Number Analyzed 1 participants
11100
Subject 06: Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
1480
Subject 07: Vandetanib concentration centre of tumour Number Analyzed 1 participants
4570
Subject 07: Vandetanib concentration middle of tumour Number Analyzed 1 participants
531
Subject 07: Vandetanib concentration edge of tumour Number Analyzed 1 participants
441
Subject 07: Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
2760
Subject 08: Vandetanib concentration centre of tumour Number Analyzed 1 participants
1140
Subject 08 (1cm lesion): whole tumour Vandetanib concentration Number Analyzed 1 participants
93500
Subject 08 (inferior lesion): Vandetanib concentration centre of tumour Number Analyzed 1 participants
6180
Subject 08: Vandetanib concentration middle of tumour Number Analyzed 1 participants
1240
Subject 08 (inferior lesion): Vandetanib concentration middle of tumour Number Analyzed 1 participants
1440
Subject 08: Vandetanib concentration edge of tumour Number Analyzed 1 participants
2840
Subject 08 (inferior lesion): Vandetanib concentration edge of tumour Number Analyzed 1 participants
2710
Subject 08: Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
29100
Subject 08 (1 cm lesion): Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
5350
Subject 08 (inferior lesion): Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
6010
4.Primary Outcome
Title Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
Hide Description 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
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
all participants treated with BTG-002814
Arm/Group Title BTG-002814
Hide Arm/Group Description:

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814: BTG-002814 containing 100 mg vandetanib

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: hours
Vandetanib Plasma Tmax 26.0  (67.08)
N-desmethyl Plasma Tmax 0.8  (1.04)
5.Primary Outcome
Title Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814
Hide Description 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).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
all participants treated with BTG-002814
Arm/Group Title BTG-002814
Hide Arm/Group Description:

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
Vandetanib Plasma AUCEoS 6979.3  (3188.21)
N-desmethyl Plasma AUCEoS 81.1  (169.40)
6.Primary Outcome
Title Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Hide Description 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).
Time Frame Following surgical resection of tumour
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title BTG-002814
Hide Arm/Group Description:

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: ng/mL
Subject 01: N-desmethyl Vandetanib concentration centre of tumour Number Analyzed 1 participants
4620
Subject 01: N-desmethyl Vandetanib concentration middle of tumour Number Analyzed 1 participants
4740
Subject 01: N-desmethyl Vandetanib concentration edge of tumour Number Analyzed 1 participants
3680
Subject 01: N-desmethyl Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
280
Subject 03: N-desmethyl concentration centre of tumour Number Analyzed 1 participants
69.6
Subject 03: N-desmethyl Vandetanib concentration middle of tumour Number Analyzed 1 participants
59.8
Subject 03: N-desmethyl Vandetanib concentration edge of tumour Number Analyzed 1 participants
69.2
Subject 03: N-desmethyl Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
831
Subject 05: N-desmethyl concentration centre of tumour Number Analyzed 1 participants
421
Subject 05: N-desmethyl Vandetanib concentration middle of tumour Number Analyzed 1 participants
418
Subject 05: N-desmethyl Vandetanib concentration edge of tumour Number Analyzed 1 participants
469
Subject 05: N-desmethyl Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
544
Subject 06: N-desmethyl concentration centre of tumour Number Analyzed 1 participants
113
Subject 06: N-desmethyl Vandetanib concentration middle of tumour Number Analyzed 1 participants
93.9
Subject 06: N-desmethyl Vandetanib concentration edge of tumour Number Analyzed 1 participants
11.4
Subject 06: N-desmethyl Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
55.6
Subject 07: N-desmethyl concentration centre of tumour Number Analyzed 1 participants
21
Subject 07: N-desmethyl Vandetanib concentration middle of tumour Number Analyzed 1 participants
15.7
Subject 07: N-desmethyl Vandetanib concentration edge of tumour Number Analyzed 1 participants
28.7
Subject 07: N-desmethyl Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
84
Subject 08: N-desmethyl concentration centre of tumour Number Analyzed 1 participants
39.3
Subject 08 (1cm lesion): whole tumour N-desmethyl concentration Number Analyzed 1 participants
208
Subject 08 (inferior lesion): N-desmethyl concentration centre of tumour Number Analyzed 1 participants
80.2
Subject 08: N-desmethyl Vandetanib concentration middle of tumour Number Analyzed 1 participants
57.1
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration middle of tumour Number Analyzed 1 participants
101
Subject 08: N-desmethyl Vandetanib concentration edge of tumour Number Analyzed 1 participants
145
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration edge of tumour Number Analyzed 1 participants
171
Subject 08: N-desmethyl Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
389
Subject 08 (1 cm lesion): N-desmethyl Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
342
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration 1cm away from tumour Number Analyzed 1 participants
405
7.Secondary Outcome
Title Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Hide Description 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.
Time Frame 1 day after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title BTG-002814
Hide Arm/Group Description:

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: µL
Subject 01: Liver Number Analyzed 1 participants
928.83
Subject 01: Registered sample Number Analyzed 1 participants
399.27
Subject 01: Tumour Number Analyzed 1 participants
361.14
Subject 01: tumour dilated 1cm Number Analyzed 1 participants
393.79
Subject 01: Tumour dilated 2cm Number Analyzed 1 participants
479.28
Subject 02: Liver Number Analyzed 1 participants
764.69
Subject 02: Tumour Number Analyzed 1 participants
596.78
Subject 02: Tumour dilated 1cm Number Analyzed 1 participants
617.72
Subject 02: Tumour dilated 2cm Number Analyzed 1 participants
649.97
Subject 03: Liver Number Analyzed 1 participants
594.79
Subject 03: Registered sample Number Analyzed 1 participants
116.54
Subject 03: Tumour Number Analyzed 1 participants
0.32
Subject 03: Tumour dilated 1cm Number Analyzed 1 participants
36.26
Subject 03: Tumour dilated 2cm Number Analyzed 1 participants
108.85
Subject 04: Liver Number Analyzed 1 participants
852.03
Subject 05: Liver Number Analyzed 1 participants
849.29
Subject 05: Registered sample Number Analyzed 1 participants
751.62
Subject 05: Tumour Number Analyzed 1 participants
0
Subject 5: Tumour dilated 1cm Number Analyzed 1 participants
15.26
Subject 05: Tumour dilated 2cm Number Analyzed 1 participants
86.28
Subject 06: Liver Number Analyzed 1 participants
202.56
Subject 06: Registered sample Number Analyzed 1 participants
148.09
Subject 06: Tumour Number Analyzed 1 participants
51.14
ubject 06: Tumour dilated 1cm Number Analyzed 1 participants
115.39
Subject 06: Tumour dilated 2cm Number Analyzed 1 participants
166.80
Subject 07: Liver Number Analyzed 1 participants
720.78
Subject 07: Registered sample Number Analyzed 1 participants
103.82
Subject 07: Tumour Number Analyzed 1 participants
4.32
Subject 07: Tumour dilated 1cm Number Analyzed 1 participants
75.43
Subject 07: Tumour dilated 2cm Number Analyzed 1 participants
133.26
Subject 08: Liver Number Analyzed 1 participants
693.73
Subject 08: Registered sample Number Analyzed 1 participants
422.37
Subject 08: Tumour Number Analyzed 1 participants
21.87
Subject 08: Tumour dilated 1cm Number Analyzed 1 participants
264.90
Subject 08: Tumour dilated 2cm Number Analyzed 1 participants
378.15
8.Secondary Outcome
Title Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability
Hide Description 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.
Time Frame Post-surgery (tumour resection)
Hide Outcome Measure Data
Hide Analysis Population Description
all participants treated with BTG-002814
Arm/Group Title BTG-002814
Hide Arm/Group Description:

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: percentage of surgical specimen
Tumour necrosis
92.5
(5 to 100)
Viable tumour
7.5
(0 to 95)
9.Secondary Outcome
Title Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes.
Hide Description 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.
Time Frame Post-surgery (tumour resection)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BTG-002814
Hide Arm/Group Description:

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Count of Participants
Vascular changes absent 8
Vascular changes present 0
10.Secondary Outcome
Title Assessment of Changes in Blood Flow on Dynamic Contrast-Enhanced (DCE) MRI Following Treatment With BTG-002814. The Following Parameters Will be Derived From DCE-MRI Images: Ktrans, Kep and Ve.
Hide Description

After 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.

Time Frame Baseline, pre-treatment, up to 3 days prior to surgical resection of tumour
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Study Blood Biomarkers With the Potential to Identify Patients Likely to Respond to Treatment With BTG-002814
Hide Description 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.
Time Frame Baseline, pre-treatment, 1 day after treatment, Up to 3 days prior to surgical resection, end of study (28-32 days post-surgery).
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Study Tissue Biomarkers to Explore Key Immune, Inflammatory and Drug Related Mechanisms
Hide Description 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).
Time Frame Baseline, pre-treatment, Up to 3 days prior to surgical resection.
Outcome Measure Data Not Reported
Time Frame 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)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BTG-002814
Hide Arm/Group Description

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib

All-Cause Mortality
BTG-002814
Affected / at Risk (%)
Total   1/8 (12.50%)    
Hide Serious Adverse Events
BTG-002814
Affected / at Risk (%) # Events
Total   4/8 (50.00%)    
Gastrointestinal disorders   
Ileus * 1  1/8 (12.50%)  1
Upper gastrointestinal hemorrhage * 1  1/8 (12.50%)  1
Hepatobiliary disorders   
Ascites * 1  1/8 (12.50%)  1
Post procedural bile leak * 1  1/8 (12.50%)  1
Infections and infestations   
Lung infection * 1  1/8 (12.50%)  1
Postoperative wound infection * 1  2/8 (25.00%)  2
Sepsis * 1  1/8 (12.50%)  1
Injury, poisoning and procedural complications   
Abdominal wound dehiscence * 1  1/8 (12.50%)  1
Renal and urinary disorders   
Renal failure acute * 1  1/8 (12.50%)  1
1
Term from vocabulary, MedDRA (21.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BTG-002814
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Cardiac disorders   
Bradycardia * 1  3/8 (37.50%)  5
Cardiac signs and symptoms NEC * 1  1/8 (12.50%)  1
Sinus bradycardia * 1  2/8 (25.00%)  2
Ear and labyrinth disorders   
Tinnitus * 1  2/8 (25.00%)  2
Gastrointestinal disorders   
Abdominal distension * 1  1/8 (12.50%)  2
Abdominal pain * 1  8/8 (100.00%)  19
Constipation  1  5/8 (62.50%)  6
Diarrhoea * 1  1/8 (12.50%)  1
Dry mouth * 1  1/8 (12.50%)  1
Dyspepsia * 1  5/8 (62.50%)  8
Gastritis * 1  2/8 (25.00%)  2
Gastrooesophageal reflux disease * 1  2/8 (25.00%)  2
Nausea * 1  5/8 (62.50%)  8
Vomiting * 1  2/8 (25.00%)  2
General disorders   
Fatigue * 1  7/8 (87.50%)  23
Influenza like illness * 1  1/8 (12.50%)  1
Non-cardiac chest pain * 1  1/8 (12.50%)  1
Pain * 1  2/8 (25.00%)  2
Pyrexia * 1  2/8 (25.00%)  2
Infections and infestations   
Lung infection * 1  1/8 (12.50%)  1
Postoperative wound infection * 1  2/8 (25.00%)  3
Investigations   
Alanine aminotransferase * 1  5/8 (62.50%)  8
Aspartate aminotransferase * 1  5/8 (62.50%)  7
Blood albumin * 1  3/8 (37.50%)  25
Blood alkaline phosphatase * 1  5/8 (62.50%)  5
Blood bilirubin * 1  1/8 (12.50%)  1
Blood calcium * 1  2/8 (25.00%)  2
Blood creatinine * 1  2/8 (25.00%)  7
Blood glucose * 1  5/8 (62.50%)  8
Blood lactic acid * 1  1/8 (12.50%)  1
Blood magnesium * 1  1/8 (12.50%)  1
Blood sodium * 1  1/8 (12.50%)  1
Blood thyroid stimulating hormone * 1  2/8 (25.00%)  2
Blood urea * 1  2/8 (25.00%)  2
Blood uric acid * 1  4/8 (50.00%)  6
C-reactive protein * 1  1/8 (12.50%)  14
Electrocardiogram QT prolonged * 1  2/8 (25.00%)  4
Gamma-glutamyl transferase * 1  5/8 (62.50%)  8
Glomerular filtration rate * 1  1/8 (12.50%)  1
Haemoglobin * 1  8/8 (100.00%)  15
International normalized ratio  1  1/8 (12.50%)  1
Neutrophil count * 1  1/8 (12.50%)  11
Neutrophil count decreased * 1  4/8 (50.00%)  6
Platelet count * 1  2/8 (25.00%)  2
Weight decreased * 1  3/8 (37.50%)  3
White blood cell count * 1  2/8 (25.00%)  14
Metabolism and nutrition disorders   
Decreased appetite * 1  5/8 (62.50%)  7
Dehydration * 1  1/8 (12.50%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/8 (25.00%)  2
Back pain * 1  2/8 (25.00%)  2
Groin pain * 1  1/8 (12.50%)  2
Myalgia * 1  1/8 (12.50%)  1
Nervous system disorders   
Paraesthesia * 1  2/8 (25.00%)  2
Psychiatric disorders   
Delirium * 1  1/8 (12.50%)  1
Insomnia * 1  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  2/8 (25.00%)  2
Dysphonia * 1  1/8 (12.50%)  1
Dyspnoea * 1  2/8 (25.00%)  2
Hiccups * 1  2/8 (25.00%)  2
Laryngeal inflammation * 1  1/8 (12.50%)  1
Oropharyngeal pain * 1  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Dermatitis acneiform * 1  1/8 (12.50%)  1
Pruritus * 1  1/8 (12.50%)  1
Rash * 1  1/8 (12.50%)  1
Vascular disorders   
Haematoma * 1  1/8 (12.50%)  2
Hypertension * 1  7/8 (87.50%)  12
Hypotension * 1  3/8 (37.50%)  4
1
Term from vocabulary, MedDRA (21.0)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sarah Cooper
Organization: Biocompatibles UK Ltd
Phone: 07805354224
EMail: Sarah-Jane.Cooper@bsci.com
Layout table for additonal information
Responsible Party: Biocompatibles UK Ltd
ClinicalTrials.gov Identifier: NCT03291379    
Other Study ID Numbers: BTG-002814-01
First Submitted: May 17, 2017
First Posted: September 25, 2017
Results First Submitted: October 5, 2020
Results First Posted: February 3, 2021
Last Update Posted: February 3, 2021