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| Name | Class |
|---|---|
| US Biotest, Inc. | INDUSTRY |
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Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.
In this open-label, dose-escalating, Phase IIa trial, subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
Subjects will be enrolled in sequential cohorts of NanoPac® at escalating doses, at a volume based on up to 20% of calculated tumor volume (with a maximum injection volume of 5 mL per subject). During the first phase of the trial (dose escalation), each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling, an additional three subjects at the current dose may be enrolled, or if the first dose does not provide adequate safety and tolerability the study may be halted.
The dose determined to be most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile as determined by the Data Safety Monitoring Board (DSMB), will be the dose used in the second phase of the study which will enroll 22 additional subjects who will receive two injections of NanoPac® at the same dose one month apart. In the third phase of the study, up to 30 subjects will receive up to four injections of NanoPac at the same dose, one month apart.
Plasma samples will be taken at various time points on the day of NanoPac® injection as well as once at each of the study visits, to characterize the pharmacokinetics (PK) of ITU NanoPac®.
Subjects will be followed for 12 months after NanoPac® injection for safety, overall survival (OS), progression-free survival (PFS), CA-19-9 levels, carcinoembryonic antigen (CEA) levels, reduction in pain, and tumor response to therapy (as shown by imaging).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation: NanoPac® 6 mg/mL | Experimental | Intratumorally injected NanoPac® at a volume of up to 20% tumor volume |
|
| Dose Escalation: NanoPac® 10 mg/mL | Experimental | Intratumorally injected NanoPac® at a volume of up to 20% tumor volume |
|
| Dose Escalation: NanoPac® 15 mg/mL | Experimental | Intratumorally injected NanoPac® at a volume of up to 20% tumor volume |
|
| Second Phase: NanoPac® at Best Dose | Experimental | Intratumorally injected NanoPac® at a volume of up to 20% tumor volume. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive two NanoPac® administrations, with the second injection administered one month after the first injection. |
|
| Third Phase: NanoPac® at Best Dose | Experimental | Intratumorally injected NanoPac® at a volume of up to 20% tumor volume. The dose administered in the third phase will be determined during the dose escalation phase. Subjects will receive four NanoPac® administrations, with the injections administered one month apart. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoPac® | Drug | Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs. | Up to Week 24 for Dose Escalation subjects; up to Week 28 for Second Phase subjects; up to 9 Months for Third Phase subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Target Tumor Assessment | Response was determined using RECIST 1.1 parameters (complete response, partial response, stable disease, progressive disease, unevaluable) for the treated lesion in all groups. | Week 24 |
| Plasma Paclitaxel Concentration (pg/mL) |
Not provided
Inclusion Criteria:
Signed informed consent;
Age ≥18 years;
Histologically/cytologically confirmed locally advanced pancreatic adenocarcinoma; at least one lesion with a diameter of at least 1.5 cm but no more than 6 cm as documented via imaging (within 6 weeks of Screening);
Subject not a candidate for surgery;
Completion of at least one standard of care IV chemotherapy course for subjects in the dose escalation phase of the study. IV chemotherapy will be initiated prior to first NanoPac injection for subjects in the second and third phases. Hematologic recovery must be confirmed prior to study entry;
Performance Status (ECOG) 0-1 at study entry;
Life expectancy of at least 3 months;
Adequate marrow, liver, and renal function at study entry:
Effective contraception if the risk of conception exists.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shelagh Verco, PhD | Vice President, Clinical Development, NanOlogy, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Parkview Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19097774 | Background | Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. | |
| Background | Taxol® (paclitaxel) Injection Package Insert. Bristol-Myers Squibb Company. Rev July 2011. | ||
| Background | ABRAXANE Package Insert. Celgene Company. Rev July 2015. | ||
| 24131140 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation: NanoPac® 6 mg/mL | Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. |
| FG001 | Dose Escalation: NanoPac® 10 mg/mL | Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. |
| FG002 | Dose Escalation: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. |
| FG003 | Second Phase: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection. |
| FG004 | Third Phase: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose Escalation: NanoPac® 6 mg/mL | Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. |
| BG001 | Dose Escalation: NanoPac® 10 mg/mL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs. | Posted | Count of Participants | Participants | Up to Week 24 for Dose Escalation subjects; up to Week 28 for Second Phase subjects; up to 9 Months for Third Phase subjects. |
|
Up to 9 months
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Escalation: NanoPac® 6 mg/mL | Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Mitchell | NanOlogy, LLC | 8179004074 | Mark.Mitchell@dfb.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2020 | Jan 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2023 | Jan 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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Open-label, dose-escalating, Phase IIa trial.
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|
|
Plasma paclitaxel concentrations were analyzed in the dose escalation phase on Day 1 prior to injection and at 1, 2, 4, 6, and 24 hours after NanoPac injection, as well as at all other study visits. In the second and third phases, plasma paclitaxel concentrations were analyzed on Day 1 prior to NanoPac injection, and at 1 and 2 hours post NanoPac injection on all injection occasions, and at all study visits. |
| Day 1 and Week 24 |
| Pain (Visual Analog Scale) Score | The visual analog scale (VAS) ranks pain from numbers 0 (no pain) to 10 (most pain). Lower scores mean a better outcome. | Day 1 (pre-injection) and Week 24 |
| Serum CA19-9 Level | CA19-9 is a tumor marker for pancreatic cancer. Serum CA19-9 levels were assessed at all study visits. | Day 1 (Pre-Injection) and Week 24 |
| Serum CEA Levels | Carcinoembryonic antigen (CEA) is a tumor marker for pancreatic cancer. | Day 1 (Pre-Injection) and Week 24 |
| Fort Wayne |
| Indiana |
| 46845 |
| United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Background |
| Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16. |
| 37782888 | Derived | Sharma NR, Lo SK, Hendifar A, Othman MO, Patel K, Mendoza-Ladd A, Verco S, Maulhardt HA, Verco J, Wendt A, Marin A, Schmidt CM, diZerega G. Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome. Pancreas. 2023 Mar 1;52(3):e179-e187. doi: 10.1097/MPA.0000000000002236. |
| Death |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Disease Progression |
|
| Withdrawn to proceed to surgery |
|
| Subject entered hospice care |
|
Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.
| BG002 | Dose Escalation: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. |
| BG003 | Second Phase: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection. |
| BG004 | Third Phase: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Dose Escalation: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. |
| OG003 | Second Phase: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection. |
| OG004 | Third Phase: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart. |
|
|
| Secondary | Target Tumor Assessment | Response was determined using RECIST 1.1 parameters (complete response, partial response, stable disease, progressive disease, unevaluable) for the treated lesion in all groups. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | Plasma Paclitaxel Concentration (pg/mL) | Plasma paclitaxel concentrations were analyzed in the dose escalation phase on Day 1 prior to injection and at 1, 2, 4, 6, and 24 hours after NanoPac injection, as well as at all other study visits. In the second and third phases, plasma paclitaxel concentrations were analyzed on Day 1 prior to NanoPac injection, and at 1 and 2 hours post NanoPac injection on all injection occasions, and at all study visits. | Not all subjects had data at all timepoints. On Day 1, data available for one subject in dose escalation 6 mg/mL, none in 10 mg/mL, and one in 15 mg/mL; second phase, six subjects; third phase three subjects. At Week 24, data available for one subject in dose escalation 6 mg/mL, none in 10 mg/mL, none in 15 mg/mL; second phase, eight subjects; third phase five subjects. Forty subjects received concomitant IV chemotherapy while on study; of these, 14 received concomitant taxane therapy. | Posted | Mean | Standard Deviation | pg/mL | Day 1 and Week 24 |
|
|
|
| Secondary | Pain (Visual Analog Scale) Score | The visual analog scale (VAS) ranks pain from numbers 0 (no pain) to 10 (most pain). Lower scores mean a better outcome. | Pain measured with VAS was not available for all subjects at all timepoints. For the Day 1 Pre-Injection timepoint, there was one subject in the 6 mg/mL dose escalation group for whom VAS was not available. For the Week 24 timepoint, there was one subject in the 6 mg/mL dose escalation group, three in the 15 mg/mL dose escalation group, 12 in the second phase, and 9 in the third phase for whom VAS data was not available. | Posted | Mean | Standard Deviation | units on a scale | Day 1 (pre-injection) and Week 24 |
|
|
|
| Secondary | Serum CA19-9 Level | CA19-9 is a tumor marker for pancreatic cancer. Serum CA19-9 levels were assessed at all study visits. | Missing CA19-9 data for Day 1: dose escalation 6 mg/mL two subjects; second phase two subjects; third phase three subjects. Missing CA19-9 data for Week 24: dose escalation 6 mg/mL one subject; dose escalation 15 mg/mL two subjects; second phase 10 subjects; third phase nine subjects. | Posted | Mean | Standard Deviation | U/mL | Day 1 (Pre-Injection) and Week 24 |
|
|
|
| Secondary | Serum CEA Levels | Carcinoembryonic antigen (CEA) is a tumor marker for pancreatic cancer. | Missing CEA data for Day 1: dose escalation 6 mg/mL one subject; second phase two subjects; third phase two subjects. Missing CEA data for Week 24: dose escalation 6 mg/mL one subject; dose escalation 15 mg/mL three subjects; second phase 11 subjects; third phase nine subjects. | Posted | Mean | Standard Deviation | ug/L | Day 1 (Pre-Injection) and Week 24 |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Dose Escalation: NanoPac® 10 mg/mL | Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG002 | Dose Escalation: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. | 1 | 4 | 3 | 4 | 4 | 4 |
| EG003 | Second Phase: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received two NanoPac® administrations, with the second injection administered one month after the first injection. | 1 | 25 | 13 | 25 | 23 | 25 |
| EG004 | Third Phase: NanoPac® 15 mg/mL | Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received up to four NanoPac® administrations, with injections administered one month apart. | 3 | 19 | 8 | 19 | 19 | 19 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Duodenal obstruction | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA (20.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Retroperitoneal lymphadenopathy | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Duodenal stenosis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hepatic lesion | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Medical device site cellulitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Full blood count abnormal | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Pancreatic enzymes decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Urine analysis abnormal | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Senile osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA (20.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bladder trabeculation | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Choluria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Genital rash | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Antiviral prophylaxis | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
Not provided
Not provided
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| Partial Response |
|
| Stable Disease |
|
| Progressive Disease |
|
| Not evaluable |
|
|
| Week 24 |
|
|
|
| Week 24 |
|
|
|
| Week 24 |
|
|
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| Week 24 |
|
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