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An early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using TraceIT tissue spacer to create space between pancreas and duodenum in patients with localized Pancreatic Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TraceIT Tissue Spacer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TraceIT Tissue Spacer implantation | Device | The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy). | 2-6 week assessment post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Radio-Therapy Benefits of TraceIT | Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | Scores for the visualization of the fiducial marker and TraceIT hydrogel. | 2-5 weeks assessment post procedure |
| TraceIT Stability and Space Measurements |
Inclusion Criteria:
Age ≥18 years old
Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines
Tumor is clearly delineable from duodenum and no clear evidence of invasion of the duodenum is seen at time of EUS performed for either diagnosis or fiducial placement.
Subject is able to comply with motion management guidelines.
Radiotherapy or chemoradiotherapy for treatment of the disease is indicated.
In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration.
Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:
Zubrod Performance Status 0-2
Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
Life expectancy of at least 9 months
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medicine | Baltimore | Maryland | 21287 | United States | ||
| Massachusetts General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | TraceIT Tissue Spacer | TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Modified Intent to Treat (MITT)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TraceIT Tissue Spacer | TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Safety Endpoint | Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy). | Modified Intent to Treat (MITT) | Posted | Count of Participants | Participants | 2-6 week assessment post-procedure |
|
|
Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit.
Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected.
All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
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 | TraceIT Tissue Spacer | TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeya Satheesh | Boston Scientific | 6124490870 | jeya.satheesh@bsci.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 27, 2019 | Jul 12, 2022 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2021 | Jul 15, 2022 | SAP_004.pdf |
Not provided
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
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| 2-6 week assessment |
| Feasibility of TraceIT | Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP). | 2-6 week assessment post-procedure |
| TraceIT Persistence (at 6-months Post-treatment) | Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up. | 2-6 weeks and 6 month post procedure |
| Theoretical Dose Escalation From Post-TraceIT Treatment Plan | Maximum dose to the GTV while maintaining duodenal dose constraints | 2-6 week assessment Post-procedure |
| Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Number of subject with Duodenal AE summarized by CTCAE grade and timing | 18 months post procedure |
| Incidence of Resection Following the Completion of Radiation Therapy (RT) | Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection). | 2-6 weeks post procedure |
| Progression Free and Overall Survival | Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month. | 18 months post procedure |
| Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. | Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month |
The stability of TraceIT was measured as the minimum distance from the fiducial marker to TraceIT gel. Space measurements were taken before and after TraceIT was injected, which measured the preduodenal space using the axial view along the head of the HOP.
| Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy |
| Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | The QLQ-PAN26 questionnaire is a survey designed to assess patient-reported symptoms of patients undergoing treatment for pancreatic cancer. All of the scales and single item measures range in score from 0-100. A high score for the symptom scales and/or single items represents a high level of symptomatology or problems, whereas a high score for the functional scales represents a high level of functioning. | Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26 |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Radio-Therapy Benefits of TraceIT | Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution. | Modified Intent to Treat (MITT) | Posted | Count of Participants | Participants | 2-6 week assessment |
|
|
|
| Secondary | Feasibility of TraceIT | Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP). | Modified Intent to Treat (MITT) | Posted | Count of Participants | Participants | 2-6 week assessment post-procedure |
|
|
|
| Secondary | TraceIT Persistence (at 6-months Post-treatment) | Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up. | Modified Intent to Treat (MITT) | Posted | Count of Participants | Participants | 2-6 weeks and 6 month post procedure |
|
|
|
| Secondary | Theoretical Dose Escalation From Post-TraceIT Treatment Plan | Maximum dose to the GTV while maintaining duodenal dose constraints | Modified Intent to Treat (MITT) | Posted | Mean | Standard Deviation | Gy | 2-6 week assessment Post-procedure |
|
|
|
| Secondary | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Number of subject with Duodenal AE summarized by CTCAE grade and timing | Modified Intent to Treat (MITT) | Posted | Number | participants | 18 months post procedure |
|
|
|
| Secondary | Incidence of Resection Following the Completion of Radiation Therapy (RT) | Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection). | Modified Intent to Treat (MITT) | Posted | Count of Participants | Participants | 2-6 weeks post procedure |
|
|
|
| Secondary | Progression Free and Overall Survival | Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month. | Modified Intent to Treat (MITT) | Posted | Mean | Standard Deviation | months | 18 months post procedure |
|
|
|
| Secondary | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. | Modified Intent to Treat (MITT) | Posted | Mean | Full Range | Scores on a scale | Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month |
|
|
|
| Other Pre-specified | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | Scores for the visualization of the fiducial marker and TraceIT hydrogel. | Modified Intent to Treat (MITT) | Posted | Count of Participants | Participants | 2-5 weeks assessment post procedure |
|
|
|
| Other Pre-specified | TraceIT Stability and Space Measurements | The stability of TraceIT was measured as the minimum distance from the fiducial marker to TraceIT gel. Space measurements were taken before and after TraceIT was injected, which measured the preduodenal space using the axial view along the head of the HOP. | Modified Intent to Treat (MITT) | Posted | Mean | Standard Deviation | mm | Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy |
|
|
|
| Other Pre-specified | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | The QLQ-PAN26 questionnaire is a survey designed to assess patient-reported symptoms of patients undergoing treatment for pancreatic cancer. All of the scales and single item measures range in score from 0-100. A high score for the symptom scales and/or single items represents a high level of symptomatology or problems, whereas a high score for the functional scales represents a high level of functioning. | Modified Intent to Treat | Posted | Mean | Full Range | score on a scale | Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26 |
|
|
|
| 3 |
| 6 |
| 6 |
| 6 |
| 6 |
| 6 |
| Acute Cholangitis | Hepatobiliary disorders | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Ataxia | Nervous system disorders | Systematic Assessment |
|
| Bile Duct Stenosis | Hepatobiliary disorders | Systematic Assessment |
|
| Death due to Disease progression/worsening of Pancreatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Disease recurrence in the pancreas and metastasis to the lower lobe of the right lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Gastrointestinal disorder- Other | Gastrointestinal disorders | Systematic Assessment | Cholangitis |
|
| Gastrointestinal disorders- Other | Gastrointestinal disorders | Systematic Assessment | Obstructive hyperbilirubinemia |
|
| Gastrointestinal disorders- Other | Gastrointestinal disorders | Systematic Assessment | Liver Abscess |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hemorrhagic Stroke | Nervous system disorders | Systematic Assessment |
|
| High Fever | General disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Infections and infestations- Other | Infections and infestations | Systematic Assessment | bacterial peritonitis |
|
| Infections and infestations- Other | Infections and infestations | Systematic Assessment | Influenza B |
|
| Infections and infestations- Other | Infections and infestations | Systematic Assessment | Coronavirus HKU1 |
|
| Investigations - Other, | Investigations | Systematic Assessment | Blood Bilirubin Increased |
|
| Musculoskeletal and connective tissue disorder- Other | Musculoskeletal and connective tissue disorders | Systematic Assessment | Right Thoracic Facet Spondylosis |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | distant metastasis |
|
| Nervous system disorders- Other | Nervous system disorders | Systematic Assessment | Cancer-Related Pain |
|
| Neuralgia | Nervous system disorders | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | Systematic Assessment |
|
| Renal and urinary disorders - Other | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory depression |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | hypercapnic respiratory failure |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | bacterial pneumonia |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | pneumonia |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Surgical and medical procedures - Other | Surgical and medical procedures | Systematic Assessment | Drain site erythema |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Systematic Assessment | Thrombocytopenia |
|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cardiac disorders - Other | Cardiac disorders | Systematic Assessment | pulmonary embolism |
|
| Chills | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Decreased Leukocytes - Grade 2 | Investigations | Systematic Assessment |
|
| Decreased Neutrophils - Grade 2 | Investigations | Systematic Assessment |
|
| Decreased Platelet Count - Grade 1 | Investigations | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Disease Progression | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Edema face | General disorders | Systematic Assessment |
|
| Edema limbs | General disorders | Systematic Assessment |
|
| Erythmatous Injection Sites | General disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders | Systematic Assessment | inguinal hernia |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders | Systematic Assessment | Paraesophageal Hernia |
|
| General disorders and administration site conditions - Other | General disorders | Systematic Assessment | Temperature regulation disorder |
|
| General disorders and administration site conditions - Other | General disorders | Systematic Assessment | localized edema - lower extremity |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Hepatobiliary disorders - Other | Hepatobiliary disorders | Systematic Assessment | Hepatic steatosis |
|
| Hot flashes | Vascular disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Investigations - Other | Investigations | Systematic Assessment | Blood bilirubin increased |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Localized edema | General disorders | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | Systematic Assessment |
|
| Mild Chest Cold | Infections and infestations | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | Systematic Assessment | Throracolumbar Spondylosis without Radiculopathy |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | Systematic Assessment | generalized muscle weakness |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | Systematic Assessment | abnormalities of gait |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | Systematic Assessment | decreased mobility |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | Systematic Assessment | left ankle pain |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Nervous system disorders - Other | Nervous system disorders | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Occasional Leg Cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Occasional Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Occasional Vomiting | General disorders | Systematic Assessment |
|
| Oral Thrush | Infections and infestations | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain Near Incision Site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Pruiritic Injection Sites | General disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Psychiatric disorders - Other | Psychiatric disorders | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Renal and urinary disorders - Other | Renal and urinary disorders | Systematic Assessment | Glucosuria Present Grade 1 |
|
| Renal and urinary disorders - Other | Renal and urinary disorders | Systematic Assessment | chronic renal insufficiency |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | pneumonia |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | reactive airway disease |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | shortness of breath |
|
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Vascular disorders - Other | Vascular disorders | Systematic Assessment | swelling of leg (left) |
|
| Weight loss | Investigations | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| Yes |
|
| Migration |
|
|
|
| Subjects who have one or more grade 3 duodenal AEs |
|
| Subjects who have one or more grade 4 duodenal AEs |
|
| Subjects who have one or more grade 5 duodenal AEs |
|
| Subjects who only have grade N/A duodenal AEs |
|
| Subjects who have one or more duodenal AEs |
|
|
|
| Physical functioning |
|
|
| Role Functioning |
|
|
| Emotional Functioning |
|
|
| Cognitive Functioning |
|
|
| Social Functioning |
|
|
| Fatigue |
|
|
| Nausea and Vomiting |
|
|
| Pain |
|
|
| Dyspnea |
|
|
| Insomnia |
|
|
| Appetite loss |
|
|
| Constipation |
|
|
| Diarrhea |
|
|
| Financial Difficulties |
|
|
| 4-Partially distinct border, partial haze |
|
| 5- Clearly visualized, unequivocal |
|
| TraceIT hydrogel visibility scoring |
|
| TraceIT Space Measurement (mm) |
|
|
|
| Bloating |
|
|
| Digestive Symptoms |
|
|
| Taste |
|
|
| Indigestion |
|
|
| Flatulence |
|
|
| Weight Loss |
|
|
| Weakness arms and legs |
|
|
| Dry Mouth |
|
|
| Hepatic Symptoms |
|
|
| Altered Bowel Habit |
|
|
| Body Image |
|
|
| Trouble with side-effects |
|
|
| Future Worries |
|
|
| Planning of activities |
|
|
| Satisfaction with health care |
|
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| Sexuality |
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