Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Center for Cell and Gene Therapy, Baylor College of Medicine | OTHER |
| The Methodist Hospital Research Institute | OTHER |
| Pancreatic Cancer Action Network | OTHER |
Not provided
Not provided
Not provided
Not provided
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
Patients who have pancreatic cancer that has come back or has not gone away after treatment, including the standard treatment for this disease or patients who are not eligible for or have elected not to receive standard of care chemotherapy, and patients who will have surgery after treatment for pancreatic cancer are eligible for this study. This is a research study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.
The proteins that are targeted in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not show, or they show up in low quantities, on normal human cells. In this study, five common TAAs will be targeted. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study, patients have been treated and so far this treatment has shown to be safe.
Investigators now want to try this treatment in patients with pancreatic cancer.
These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not approved by the Food and Drug Administration.
*Arm A and Arm B are closed to new patient enrollment.*
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
The patient will give blood to make TAA-Specific cytotoxic T cells in a lab. These cells well be grown and frozen. If the TAA-Specific cytotoxic T cells can be made, the time from collection of the blood to manufacture of T cells for administration to the patient is about 1 to 2 months.
The cells will be infused by intravenous infusion (IV) into the patient over 1-10 minutes. The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the TAA-CTL administration.
Patients will be given up to six doses of TAA-CTLs at monthly intervals. The treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital (HMH).
MEDICAL TESTS BEFORE TREATMENT:
MEDICAL TESTS DURING TREATMENT:
Standard medical tests will be conducted on the day of the second and subsequent infusions:
MEDICAL TESTS AFTER TREATMENT:
- Measurements the patient's tumor by routine imaging studies and/or blood tests done as per standard of care.
To learn more about the way the TAA-CTLs are working in patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before the infusion, at Weeks 1 and 2 after each infusion and at weeks 4, 6 and 8 and months 3, 6, 9 and 12 after the last infusion. The blood may be drawn from a central line at the time of the patient's regular blood tests. Investigators will use this blood to see how long the TAA-CTLs last, and to look at the immune system response to the patient's cancer.
Study Duration: Patients will be active participants in this study for approximately one year after their last dose. Investigators will contact patients once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate disease response long-term.
*Arm A and Arm B are closed to new patient enrollment.*
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Closed to New Patient Enrollment) | Experimental | Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. |
|
| Group B (Closed to New Patient Enrollment) | Experimental | Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. |
|
| Group C (Closed to New Patient Enrollment) | Experimental | Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multiTAA specific T cells | Biological | Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment Related Serious Adverse Events | To determine the safety of up to 6 intravenous infusions of multiTAA-specific T cells in pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease. | 7 months |
| Number of Patients Who Received 6 Infusions of multiTAA-specific T Cells | To determine the feasibility of completing a total of 6 intravenous infusions of multiTAA-specific T cells to pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival Using the Kaplan-Meier Method | To evaluate the progression-free of patients after multiTAA-specific T cell infusions. Progression-free survival (PFS) was estimated using the Kaplan-Meier method and summarized with median survival times and 95% confidence intervals. PFS was defined as the time from the first infusion to the first occurrence of disease progression, relapse, or death from any cause. Patients without events were censored at the last follow-up date. |
Not provided
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
Inclusion Criteria:
PROCUREMENT:
TREATMENT:
Any patient with biopsy-proven pancreatic adenocarcinoma:
Group A: Patients with locally advanced or metastatic adenocarcinoma who are responding (defined as stable disease or tumor volume reduction) following 3 cycles of first line chemotherapy
Group B: Patients with locally advanced or metastatic adenocarcinoma who have failed first line chemotherapy or are intolerant, ineligible or unwilling to receive standard of care chemotherapy
Group C: Patients with resectable pancreatic cancer who have completed planned neo-adjuvant chemotherapy, radiotherapy or combination
Patients must have measurable or evaluable disease per RECIST 1.1 criteria.
Patients with life expectancy greater than or equal to 12 weeks
Age greater than or equal to 18
Pulse oximetry of greater than 95 percent on room air in patients who previously received radiation therapy
Patients with an ECOG score of ≤ 2 or Karnofsky score of 50 or greater
Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than or equal to 3x upper limit of normal, Hgb greater than or equal to 7.0 g/dl (transfusion allowed).
Patients with a creatinine less than or equal to 2x upper limit of normal for age
Patients should have been off other investigational therapy for one month prior to receiving treatment on this study.
For Groups B or C patients must be off conventional therapy for at least 1 week prior to receiving treatment on this study.
Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.
Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.
Exclusion Criteria:
PROCUREMENT:
TREATMENT:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne Leen, PhD | Baylor College of Medicine | Principal Investigator |
| Benjamin Musher, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Clinic | Houston | Texas | 77030 | United States | ||
| Houston Methodist Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41482561 | Derived | Musher BL, Vasileiou S, Smaglo BG, Robertson CS, Wu M, Wang T, Watanabe A, Kuvalekar M, Velazquez Y, Ketkar S, Doheyan TA, Papayanni PG, Shah A, Lapteva N, Grilley BJ, Van Buren G, Lulla PD, Heslop HE, Rooney CM, Brenner MK, Leen AM. Autologous multiantigen-targeted T cell therapy for pancreatic cancer: a phase 1/2 trial. Nat Med. 2026 Jan;32(1):258-269. doi: 10.1038/s41591-025-04043-5. Epub 2026 Jan 2. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. |
| FG001 | Group B | Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. |
| FG002 | Group C | Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Patients With Treatment Related Serious Adverse Events | To determine the safety of up to 6 intravenous infusions of multiTAA-specific T cells in pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease. | Participants who received at least one infusion of multiTAA-specific T cells. | Posted | Count of Participants | Participants | 7 months |
|
All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months.
Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
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 | Group A | Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Musher | Baylor College of Medicine | (713)798-3750 | blmusher@bcm.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2022 | Mar 1, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| The V Foundation for Cancer Research |
| OTHER |
| Harris County Hospital District | OTHER_GOV |
This study is designed as a fixed-dose pilot study to evaluate the safety and feasibility and efficacy of up to 6 intravenous infusions of multiTAA-specific T cells in pancreas cancer patients with metastatic, locally advanced unresectable, or resectable disease.
Not provided
Not provided
Not provided
Not provided
| 5 years |
| Overall Survival Using the Kaplan-Meier Method | To evaluate the overall survival of patients after multiTAA-specific T cell infusions. Overall survival (OS) was estimated using the Kaplan-Meier method and summarized with median survival times and 95% confidence intervals. OS was defined as the time from the first infusion to death from any cause. Patients without events were censored at the last follow-up date. | 5 years |
| Houston |
| Texas |
| 77030 |
| United States |
| Harris Health System - Smith Clinic | Houston | Texas | 77054 | United States |
| BG001 | Group B | Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. |
| BG002 | Group C | Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. |
| BG003 | 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 |
|
| OG001 | Group B | Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. |
| OG002 | Group C | Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. |
|
|
| Primary | Number of Patients Who Received 6 Infusions of multiTAA-specific T Cells | To determine the feasibility of completing a total of 6 intravenous infusions of multiTAA-specific T cells to pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease | Participants who received at least one infusion of multiTAA-specific T cells. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Progression Free Survival Using the Kaplan-Meier Method | To evaluate the progression-free of patients after multiTAA-specific T cell infusions. Progression-free survival (PFS) was estimated using the Kaplan-Meier method and summarized with median survival times and 95% confidence intervals. PFS was defined as the time from the first infusion to the first occurrence of disease progression, relapse, or death from any cause. Patients without events were censored at the last follow-up date. | The analysis population includes all participants who received at least one infusion of multiTAA-specific T cells. | Posted | Median | 95% Confidence Interval | months | 5 years |
|
|
|
| Secondary | Overall Survival Using the Kaplan-Meier Method | To evaluate the overall survival of patients after multiTAA-specific T cell infusions. Overall survival (OS) was estimated using the Kaplan-Meier method and summarized with median survival times and 95% confidence intervals. OS was defined as the time from the first infusion to death from any cause. Patients without events were censored at the last follow-up date. | The analysis population includes all participants who received at least one infusion of multiTAA-specific T cells. | Posted | Median | 95% Confidence Interval | months | 5 years |
|
|
|
| 13 |
| 13 |
| 4 |
| 13 |
| 13 |
| 13 |
| EG001 | Group B | Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. | 11 | 12 | 6 | 12 | 12 | 12 |
| EG002 | Group C | Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. | 10 | 12 | 3 | 12 | 11 | 12 |
| Sinus tachycardia | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify : Cholangitis | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify : Large bowel obstruction | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify : Ventral hernia | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Chills | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Fever | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Hepatobiliary disorders - Other, specify : Biliary Tract Obstruction | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hepatobiliary disorders - Other, specify : Biliary obstruction | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Infections and infestations - Other, specify : E. coli bacteremia | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Infections and infestations - Other, specify : Infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Lipase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Serum amylase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify : Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify : Enteritis | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify : Indigestion | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify : Melena | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Chills | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Edema face | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Edema limbs | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Fatigue | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Fever | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Flu like symptoms | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify : Body aches | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Malaise | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Pain | General disorders and administration site conditions | CTCAE v4.0 | Systematic Assessment |
|
| Hepatobiliary disorders - Other, specify : Biliary obstruction | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Lipase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify : Joint pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify : Pulled muscle | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Nervous system disorders - Other, specify : Lightheadedness | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify : Dysuria | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify : Urinary tract infection | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Urine discoloration | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify : Loss of eyelashes | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify : Rash | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| Vascular disorders - Other, specify : Pulmonary emboli | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |