## Protocol Section
### Identification Module
**NCT ID:** NCT03291379

**Acronym:** VEROnA

**Brief Title:** Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies

**Official Title:** VEROnA: A Window of Opportunity Study of Vandetanib-eluting Radiopaque Embolic Beads (BTG-002814) in Patients With Resectable Liver Malignancies

#### Organization Study ID Info
**ID:** BTG-002814-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Boston Scientific Corporation
### Status Module
#### Completion Date
**Date:** 2019-08-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-07-19

**Type:** ACTUAL

**Last Update Submit Date:** 2021-07-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-08-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-02-03

**Type:** ACTUAL

**Results First Submit Date:** 2020-10-05

**Results First Submit QC Date:** 2021-01-14

#### Start Date
**Date:** 2017-05-17

**Type:** ACTUAL

**Status Verified Date:** 2021-07

#### Study First Post Date
**Date:** 2017-09-25
**Type:** ACTUAL
**Study First Submit Date:** 2017-05-17
**Study First Submit QC Date:** 2017-09-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Biocompatibles UK Ltd

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Boston Scientific Corporation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a pilot, open label single arm phase 0 window of opportunity study of vandetanib-eluting radiopaque beads in patients with resectable liver malignancies.

**Detailed Description:** A pilot open-label single arm multicenter phase 0 window of opportunity study of BTG-002814 given up to 3 weeks prior to surgery in up to 12 patients with resectable Hepatocellular carcinoma (HCC) or Colorectal cancer (CRC) with liver metastases.

### Conditions Module

**Conditions:**

- Carcinoma, Hepatocellular

- Metastatic Colorectal Cancer

**Keywords:**

- mCRC, HCC, radiopaque beads, vandetanib

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** 1 mL BTG-002814 containing 100 mg vandetanib

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 8

**Type:** ACTUAL

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: BTG-002814

**Label:** BTG-002814

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BTG-002814

**Description:** BTG-002814 containing 100 mg vandetanib

**Name:** BTG-002814

**Other Names:**

- vandetanib-eluting radiopaque beads

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**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.

**Measure:** Study Blood Biomarkers With the Potential to Identify Patients Likely to Respond to Treatment With BTG-002814

**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).

**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).

**Measure:** Study Tissue Biomarkers to Explore Key Immune, Inflammatory and Drug Related Mechanisms

**Time Frame:** Baseline, pre-treatment, Up to 3 days prior to surgical resection.

#### Primary Outcomes

**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)

**Measure:** To Assess the Safety and Tolerability of Treatment With BTG-002814

**Time Frame:** Continuously throughout the study totalling 9 weeks

**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.

**Measure:** Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814

**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)

**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).

**Measure:** Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814

**Time Frame:** Following surgical resection of tumour

**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

**Measure:** Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814

**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)

**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).

**Measure:** Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814

**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)

**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).

**Measure:** Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814

**Time Frame:** Following surgical resection of tumour

#### Secondary Outcomes

**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.

**Measure:** Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT

**Time Frame:** 1 day after treatment

**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.

**Measure:** Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability

**Time Frame:** Post-surgery (tumour resection)

**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.

**Measure:** Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes.

**Time Frame:** Post-surgery (tumour resection)

**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.

**Measure:** 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.

**Time Frame:** Baseline, pre-treatment, up to 3 days prior to surgical resection of tumour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Male or female adults (≥ 18 years old)
2. Patient with resectable HCC (Child Pugh A, International Normalized Ratio (INR) ≤1.5) or resectable liver metastases from CRC and a candidate for liver surgery
3. Patients with low risk for surgical morbidity and mortality from liver surgery according to the investigators judgement
4. World Health Organization (WHO) performance status 0, 1 or 2
5. Adequate haematological function with Hb \>90 g/L, absolute neutrophil count \>1.5 x 10\^9/L, Plt \>100 x 10\^9/L
6. Adequate liver function with serum bilirubin \<1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) (or aspartate aminotransferase (AST) if ALT not available) ≤5 x ULN, alkaline phosphatase (ALP) \<5 x ULN
7. Adequate renal function with serum creatinine ≤1.5 x ULN and calculated creatinine clearance (GFR) ≥50 mL/min estimated using a validated creatinine clearance calculation (e.g., Cockcroft-Gault or Wright formula).
8. Patient is willing to provide blood samples, and tissue samples at surgical resection, for research purposes
9. Patient is willing and able to provide written informed consent

Exclusion Criteria:

1. Any systemic chemotherapy within 3 months of the screening visit or any plan to administer systemic chemotherapy prior to surgery
2. Previous treatment with transarterial embolisation (with or without chemotherapy) of the liver, prior radiotherapy or ablation therapy to the liver or prior yttrium-90 microsphere therapy
3. Any contraindication to vandetanib according to its local label including:

   * Hypersensitivity to the active substance
   * Congenital long corrected QT interval (QTc) syndrome
   * Patients known to have a QTc interval over 480 milliseconds
   * Concomitant use of medicinal products known to also prolong the QTc interval and/or induce Torsades de pointes
4. Any contraindication to hepatic artery catheterisation or hepatic embolisation procedures (e.g. portal venous thrombosis, severely reduced portal venous flow or hepatofugal blood flow, untreated varices at high risk of bleeding)
5. Women of childbearing potential not using effective contraception or women who are breast feeding
6. Confirmed allergy to iodine-based intravenous contrast media
7. Patients who cannot have CT, MRI or dynamic contrast-enhanced (DCE) MRI Imaging (according to site policy)
8. Active uncontrolled cardiovascular disease
9. Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk and would preclude the safe use of BTG-002814
10. Levels of potassium, calcium, magnesium or thyroid stimulating hormone (TSH) outside the normal ranges, and that in the investigator's judgement are clinically significant, or other laboratory findings that in the view of the investigator makes it undesirable for the patient to participate in the study
11. Patients who have participated in another clinical trial with an investigational product within 4 weeks prior to the screening visit

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bloomsbury

**Country:** United Kingdom

**Facility:** University College London Hospital

**State:** London

**Zip:** NW1 2BU

#### Overall Officials

**Official 1:**

**Affiliation:** University College, London

**Name:** Professor Ricky Sharma

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Beaton L, Tregidgo HFJ, Znati SA, Forsyth S, Clarkson MJ, Bandula S, Chouhan M, Lowe HL, Zaw Thin M, Hague J, Sharma D, Pollok JM, Davidson BR, Raja J, Munneke G, Stuckey DJ, Bascal ZA, Wilde PE, Cooper S, Ryan S, Czuczman P, Boucher E, Hartley JA, Lewis AL, Jansen M, Meyer T, Sharma RA. VEROnA Protocol: A Pilot, Open-Label, Single-Arm, Phase 0, Window-of-Opportunity Study of Vandetanib-Eluting Radiopaque Embolic Beads (BTG-002814) in Patients With Resectable Liver Malignancies. JMIR Res Protoc. 2019 Oct 2;8(10):e13696. doi: 10.2196/13696.

**PMID:** 31579027

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-12-03

- Filename: Prot_001.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1984491

- Type Abbrev: Prot

- Upload Date: 2020-08-20T05:30

- Date: 2019-05-16

- Filename: SAP_000.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 725837

- Type Abbrev: SAP

- Upload Date: 2020-08-19T12:59

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000008113

- Term: Liver Neoplasms

- ID: D000008107

- Term: Liver Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M9613

- Name: Carcinoma, Hepatocellular

- Relevance: HIGH

- As Found: Carcinoma, Hepatocellular

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11113

- Name: Liver Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006528

- Term: Carcinoma, Hepatocellular

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** BTG-002814

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 8

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

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

**ID:** EG000

**Other Num Affected:** 8

**Other Num at Risk:** 8

**Serious Number Affected:** 4

**Serious Number At Risk:** 8

**Title:** BTG-002814

**Frequency Threshold:** 0

#### Other Events

**Term:** Bradycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Cardiac signs and symptoms NEC

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Sinus bradycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Tinnitus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Abdominal distension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Abdominal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Dry mouth

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Dyspepsia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Gastritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Gastrooesophageal reflux disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Influenza like illness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Non-cardiac chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Lung infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Postoperative wound infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Alanine aminotransferase

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Aspartate aminotransferase

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood albumin

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood alkaline phosphatase

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood bilirubin

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood calcium

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood creatinine

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood glucose

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood lactic acid

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood magnesium

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood sodium

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood thyroid stimulating hormone

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood urea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Blood uric acid

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** C-reactive protein

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Electrocardiogram QT prolonged

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Gamma-glutamyl transferase

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Glomerular filtration rate

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Haemoglobin

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** International normalized ratio

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Neutrophil count

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Neutrophil count decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Platelet count

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Weight decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** White blood cell count

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (21.0)

**Term:** Decreased appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Dehydration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Back pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Groin pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Myalgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Paraesthesia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Delirium

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Dysphonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Dyspnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Hiccups

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Laryngeal inflammation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Oropharyngeal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Dermatitis acneiform

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Rash

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Haematoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (21.0)

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (21.0)

#### Serious Events

**Term:** Ileus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 8

**Num Events:** 1

**Term:** Upper gastrointestinal hemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (21.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 8

**Num Events:** 1

**Term:** Ascites

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (21.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 8

**Num Events:** 1

**Term:** Post procedural bile leak

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (21.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 8

**Num Events:** 1

**Term:** Lung infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (21.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 8

**Num Events:** 1

**Term:** Postoperative wound infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (21.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 8

**Num Events:** 2

**Term:** Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (21.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 8

**Num Events:** 1

**Term:** Abdominal wound dehiscence

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (21.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 8

**Num Events:** 1

**Term:** Renal failure acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (21.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 8

**Num Events:** 1

**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)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 8

**Units:** Participants

### Group

**ID:** BG000

**Title:** BTG-002814

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

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

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 50

**Upper Limit:** 69

**Value:** 62.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 7

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 7

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

**Class Title:** United Kingdom

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

**Class Title:** Grade 0 (asymptomatic)

#### Measurement

**Group ID:** BG000

**Value:** 0

**Class Title:** Grade 1 (Symptomatic, but ambulatory)

#### Measurement

**Group ID:** BG000

**Value:** 0

**Class Title:** Grade 2 (Symptomatic, <50% in bed)

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** Hepatocellular carcinoma (HCC)

#### Measurement

**Group ID:** BG000

**Value:** 6

**Class Title:** Metastatic colorectal cancer (mCRC)

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.4

**Value:** 1.6

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** World Health Organisation (WHO) Performance Status
**Unit of Measure:** Participants
### Measure 6
**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
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Tumour type
**Unit of Measure:** Participants
### Measure 7
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Number of liver lesions
**Unit of Measure:** Count
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** Sarah-Jane.Cooper@bsci.com
**Organization:** Biocompatibles UK Ltd
**Phone:** 07805354224
**Title:** Sarah Cooper
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 13.94
- **Upper Limit:** 
- **Value:** 24.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.82
- **Upper Limit:** 
- **Value:** 0.6
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 404000
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 394000
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 327000
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10800
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8510
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11000
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18800
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9120
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7340
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7550
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12500
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7090
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 160000
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 151000
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11100
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1480
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4570
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 531
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 441
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2760
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1140
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93500
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6180
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1240
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1440
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2840
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2710
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29100
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5350
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6010
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 67.08
- **Upper Limit:** 
- **Value:** 26.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.04
- **Upper Limit:** 
- **Value:** 0.8
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3188.21
- **Upper Limit:** 
- **Value:** 6979.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 169.40
- **Upper Limit:** 
- **Value:** 81.1
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4620
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4740
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3680
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 280
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 831
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 421
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 418
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 469
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 544
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 208
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 101
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 145
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 171
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 389
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 342
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 405
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 928.83
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 399.27
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 361.14
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 393.79
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 479.28
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 764.69
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 596.78
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 617.72
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 649.97
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 594.79
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 116.54
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.32
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 36.26
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 108.85
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 852.03
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 849.29
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 751.62
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.26
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 86.28
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 202.56
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 148.09
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.14
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 115.39
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 166.80
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 720.78
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 103.82
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.32
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.43
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 133.26
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 693.73
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 422.37
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.87
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 264.90
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 378.15
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 100
- **Value:** 92.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 95
- **Value:** 7.5
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 10
#### Outcome Measure 11
#### Outcome Measure 12
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**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)
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population - all participants treated with BTG-002814
**Reporting Status:** POSTED
**Time Frame:** Continuously throughout the study totalling 9 weeks
**Title:** To Assess the Safety and Tolerability of Treatment With BTG-002814
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
**ID:** OG000
**Title:** BTG-002814
#### Outcome Measure 2
**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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** all participants treated with BTG-002814
**Reporting Status:** POSTED
**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)
**Title:** Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
**Type:** PRIMARY
**Unit of Measure:** ng/mL
##### Group
**Description:** Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
**ID:** OG000
**Title:** BTG-002814
#### Outcome Measure 3
**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).
**Parameter Type:** NUMBER
**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.
**Reporting Status:** POSTED
**Time Frame:** Following surgical resection of tumour
**Title:** Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
**Type:** PRIMARY
**Unit of Measure:** ng/mL
##### Group
**Description:** Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
**ID:** OG000
**Title:** BTG-002814
#### Outcome Measure 4
**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
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** all participants treated with BTG-002814
**Reporting Status:** POSTED
**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)
**Title:** Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
**Type:** PRIMARY
**Unit of Measure:** hours
##### Group
**Description:** Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814: BTG-002814 containing 100 mg vandetanib
**ID:** OG000
**Title:** BTG-002814
#### Outcome Measure 5
**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).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** all participants treated with BTG-002814
**Reporting Status:** POSTED
**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)
**Title:** Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814
**Type:** PRIMARY
**Unit of Measure:** ng*h/mL
##### Group
**Description:** Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
**ID:** OG000
**Title:** BTG-002814
#### Outcome Measure 6
**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).
**Parameter Type:** NUMBER
**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.
**Reporting Status:** POSTED
**Time Frame:** Following surgical resection of tumour
**Title:** Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
**Type:** PRIMARY
**Unit of Measure:** ng/mL
##### Group
**Description:** Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
**ID:** OG000
**Title:** BTG-002814
#### Outcome Measure 7
**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.
**Parameter Type:** NUMBER
**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.
**Reporting Status:** POSTED
**Time Frame:** 1 day after treatment
**Title:** Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
**Type:** SECONDARY
**Unit of Measure:** µL
##### Group
**Description:** Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
**ID:** OG000
**Title:** BTG-002814
#### Outcome Measure 8
**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.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** all participants treated with BTG-002814
**Reporting Status:** POSTED
**Time Frame:** Post-surgery (tumour resection)
**Title:** Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability
**Type:** SECONDARY
**Unit of Measure:** percentage of surgical specimen
##### Group
**Description:** Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
**ID:** OG000
**Title:** BTG-002814
#### Outcome Measure 9
**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.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Post-surgery (tumour resection)
**Title:** Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes.
**Type:** SECONDARY
**Unit of Measure:** Count of Participants
##### Group
**Description:** Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
**ID:** OG000
**Title:** BTG-002814
#### Outcome Measure 10
**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.
**Reporting Status:** NOT_POSTED
**Time Frame:** Baseline, pre-treatment, up to 3 days prior to surgical resection of tumour
**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.
**Type:** SECONDARY
#### Outcome Measure 11
**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.
**Reporting Status:** NOT_POSTED
**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).
**Title:** Study Blood Biomarkers With the Potential to Identify Patients Likely to Respond to Treatment With BTG-002814
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 12
**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).
**Reporting Status:** NOT_POSTED
**Time Frame:** Baseline, pre-treatment, Up to 3 days prior to surgical resection.
**Title:** Study Tissue Biomarkers to Explore Key Immune, Inflammatory and Drug Related Mechanisms
**Type:** OTHER_PRE_SPECIFIED
### Participant Flow Module
#### Group
**Description:** Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
**ID:** FG000
**Title:** BTG-002814
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True