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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00050233 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| The Skip Viragh Foundation | OTHER |
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The purpose of this study is to estimate safety of GVAX Pancreas Vaccine (GVAX) with immune modulating doses of cyclophosphamide (Cy) followed by SBRT and FOLFIRINOX chemotherapy in pancreatic cancer patients after surgery.
This study enrolled patients with surgically resected adenocarcinoma of the pancreas who had titanium clips placed at the time of surgery in order to guide SBRT treatment.
Enrollment was based on traditional 3+3 design with grade 3-4 diarrhea and/or neutropenia defined as the dose limiting toxicity (DLT) within the first 2 cycles (8 weeks) of FOLFIRINOX. The first group of 3 patients (Cohort 1) received SBRT and full dose FOLFIRINOX. The second group of 4 patients (Cohort 2) received SBRT and modified FOLFIRINOX, and the third group of 12 patients (Cohort 3) received SBRT and modified FOLFIRINOX as well as Cy/GVAX vaccinations.
Cy/GVAX (patients 8-19): cyclophosphamide (Cy) at 200 mg/m^2 intravenously over 30 minutes the day before each vaccine. Each vaccination (GVAX) consists of six total intradermal injections of vaccine, two each in the upper right and left thighs, and two in the upper non-dominant arm. Each injection consists of approximately 2.5x10^8 cells of each cell line (PANC 6.03/PANC 10.05) for a total of 5x10^8 cells. The first dose of Cy/GVAX was given within 6-10 weeks from surgery.
Adjuvant SBRT was given 13-17 days after the first dose of Cy/GVAX. Patients receive 5 days of SBRT (6.6 gray (Gy) daily for 33 Gy total) to the tumor bed as delineated by surgical clips placed by the surgeon.
Six 28-day cycles of FOLFIRINOX, starting at least one week after completion of SBRT.
This was permitted to be given locally. Patients were evaluated for dose limiting toxicities (DLTs) within the first 2 cycles (8 weeks).
Cy/GVAX #2-5 was given every 28 days (+/- 3 days), starting 35 days (+/- 7 days) after completion of FOLFIRINOX. Patients without evidence of recurrence could then qualify for additional Cy/GVAX boosts every 6 months (every 12 months with Amendment #10) until disease recurrence, toxicity, withdrawal, or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: SBRT and FOLFIRINOX | Experimental | The initial 3 patients were treated with SBRT and full dose FOLFIRINOX and observed for the first 2 cycles (8 weeks) for dose limiting toxicities (DLTs). If 2-3 patients are observed with uncontrolled grade 3-4 diarrhea, 2-3 patients are observed with grade 3-4 thrombocytopenia, or if 3 patients are observed with grade 3-4 neutropenia within the first 2 cycles of FOLFIRINOX administration (8 weeks) then the dose level will be deemed unacceptable. |
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| Cohort 2: SBRT and modified FOLFIRINOX | Experimental | The next 4 patients were treated with SBRT and modified FOLFIRINOX and observed for the first 2 cycles (8 weeks) for dose limiting toxicities (DLTs). If no patients are observed with grade 3-4 diarrhea, thrombocytopenia, or neutropenia, then the next cohort of patients will receive SBRT, modified FOLFIRINOX, and GVAX (with Cy). |
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| Cohort 3: CY, GVAX, SBRT, and modified FOLFIRINOX | Experimental | The last 12 patients will receive Cy, GVAX, SBRT, and modified FOLFIRINOX. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide (Cy) 200 mg/m^2 administered one day prior to GVAX (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities | The number of participants experiencing grade 3-4 diarrhea, neutropenia, and thrombocytopenia within the first 2 cycles (8 weeks) of treatment, regardless of attribution. The rates of each of these toxicities were considered unacceptable if they were 40%, 60%, and 40%, respectively. A decision rule similar to the traditional 3+3 design was used to determine whether it was safe to continue on to the next cohort. | 8 weeks |
| Grade 3 or Higher Cy/GVAX-related Adverse Events | Number of participants with grade 3 or above adverse event attributed to Cy or the GVAX pancreas vaccine. Each adverse event (as defined by NCI CTCAE v4.0) was counted only once for a given subject. | 116 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was measured as the amount of time from date of surgery until death or end of follow-up. OS was censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis. Estimation based on the Kaplan-Meier curve. | 96 months |
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Inclusion Criteria (abbreviated):
Exclusion criteria (abbreviated):
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Laheru, M.D. | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: SBRT and FOLFIRINOX | Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure). Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle): Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (400 mg/m^2 bolus followed by 2,400 mg/m^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Aug 4, 2020 |
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| GVAX Pancreas Vaccine | Biological | GVAX administered one day after Cy (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence. |
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| Stereotactic Body Radiation | Radiation | Cohort 1 and 2: SBRT (6.6 Gy per day, 33 Gy total dose) will be administered over 5 days within 6-10 weeks of pancreas surgery (Whipple). Cohort 3: SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first dose of CY/GVAX. |
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| FOLFIRINOX | Drug | FOLFIRINOX is given over six 28-day cycles, starting at least 1 weeks after SBRT. FOLFIRINOX consists of the following drugs given IV on days 1 and 15 of each cycle: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (400 mg/m^2 bolus followed by 2,400 mg/m^2 continuous infusion over 46-48 hours); modified FOLFIRINOX consists of the same regimen described above but without the 400 mg/m^2 Fluorouracil bolus. |
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| Disease-free Survival (DFS) |
DFS was measured as the time from date of surgery until pancreatic cancer recurrence or death. Disease status was monitored by radiologic scans done approximately every 12 weeks. DFS was censored on the date of last radiologic scan for subjects without documentation of cancer recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve. |
| 96 months |
| Distant Metastases Free Survival (DMFS) | DMFS was measured as the amount of time from date of surgery until metastatic disease progression or death. Metastatic disease progression is the appearance of one or more new lesions outside the primary tumor area (pancreas). Disease status was monitored by radiologic scans done approximately every 12 weeks. DMFS was censored on the date of last radiographic scans for subjects without documentation of metastatic disease progression or death at the time of analysis. Estimation based on the Kaplan-Meier curve. | 96 months |
| Freedom From Local Progression (FFLP) | FFLP was measured as the time from date of surgery until disease recurrence in the pancreas or death. Disease status was monitored by radiologic scans done approximately every 12 weeks. FFLP was censored on the date of last radiographic scans for subjects without documentation of local disease recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve. | 96 months |
| FG001 | Cohort 2: SBRT and Modified FOLFIRINOX | Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure). Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle): Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (2,400 mg/m^2 continuous infusion over 46-48 hours). Dose reductions were permitted. The difference between Cohort 1 and 2 is that the Fluorouracil bolus was dropped in Cohort 2. |
| FG002 | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | Cyclophosphamide: Cyclophosphamide (CY) 200 mg/m^2 was administered one day prior to GVAX (day 0). GVAX Pancreas Vaccine (GVAX) will be administered one day after CY (day 1). One Cycle of Cy/GVAX was given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts were given every 6 months thereafter until disease recurrence. Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure). Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle): Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (2,400 mg/m^2 continuous infusion over 46-48 hours). Dose reductions were permitted. |
| COMPLETED | Completed = received all planned doses of SBRT + FOLFIRINOX (Cohorts 1 and 2), or all planned doses of SBRT + FOLFIRINOX and all 5 monthly cycles of Cy and GVAX (Cohort 3) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: SBRT and FOLFIRINOX | Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure). Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (400 mg/m^2 bolus followed by 2,400 mg/m^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted. |
| BG001 | Cohort 2: SBRT and Modified FOLFIRINOX | Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure). Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (2,400 mg/m^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted. The difference between Cohort 1 and 2 is that the Fluorouracil bolus was dropped in Cohort 2. |
| BG002 | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | Cyclophosphamide (Cy) 200 mg/m^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence. Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX. Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (2,400 mg/m^2 continuous infusion over 46-48 hours). Dose reductions were permitted. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) Classification | The ECOG scale measures performance status, with scores ranging from 0-5: 0= fully active, performs without restrictions, 1= can ambulate, but restricted in physical strenuous activity, 2= ambulatory and capable of self-care but unable to work, active for >50%of waking hours, 3= limited self-care, confined to bed or chair for >50%of waking hours, 4= completely disabled, totally confined to bed/chair, 5= deceased | Count of Participants | Participants |
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| 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 | Dose Limiting Toxicities | The number of participants experiencing grade 3-4 diarrhea, neutropenia, and thrombocytopenia within the first 2 cycles (8 weeks) of treatment, regardless of attribution. The rates of each of these toxicities were considered unacceptable if they were 40%, 60%, and 40%, respectively. A decision rule similar to the traditional 3+3 design was used to determine whether it was safe to continue on to the next cohort. | One patient in cohort 2 was not evaluable because they did not complete 2 cycles of FOLFIRINOX. | Posted | Count of Participants | Participants | 8 weeks |
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| Primary | Grade 3 or Higher Cy/GVAX-related Adverse Events | Number of participants with grade 3 or above adverse event attributed to Cy or the GVAX pancreas vaccine. Each adverse event (as defined by NCI CTCAE v4.0) was counted only once for a given subject. | Only Cohort 3 received Cy and GVAX and could be evaluated for this outcome. | Posted | Count of Participants | Participants | 116 months |
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| Secondary | Overall Survival (OS) | OS was measured as the amount of time from date of surgery until death or end of follow-up. OS was censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis. Estimation based on the Kaplan-Meier curve. | Posted | Median | 95% Confidence Interval | months | 96 months |
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| Secondary | Disease-free Survival (DFS) | DFS was measured as the time from date of surgery until pancreatic cancer recurrence or death. Disease status was monitored by radiologic scans done approximately every 12 weeks. DFS was censored on the date of last radiologic scan for subjects without documentation of cancer recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve. | Posted | Median | 95% Confidence Interval | months | 96 months |
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| Secondary | Distant Metastases Free Survival (DMFS) | DMFS was measured as the amount of time from date of surgery until metastatic disease progression or death. Metastatic disease progression is the appearance of one or more new lesions outside the primary tumor area (pancreas). Disease status was monitored by radiologic scans done approximately every 12 weeks. DMFS was censored on the date of last radiographic scans for subjects without documentation of metastatic disease progression or death at the time of analysis. Estimation based on the Kaplan-Meier curve. | Posted | Median | 95% Confidence Interval | months | 96 months |
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| Secondary | Freedom From Local Progression (FFLP) | FFLP was measured as the time from date of surgery until disease recurrence in the pancreas or death. Disease status was monitored by radiologic scans done approximately every 12 weeks. FFLP was censored on the date of last radiographic scans for subjects without documentation of local disease recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve. | Posted | Median | 95% Confidence Interval | months | 96 months |
|
116 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: SBRT and FOLFIRINOX | Stereotactic Body Radiation (SBRT, 6.6 Gy) will be administered over 5 days within 6-10 weeks of surgery (Whipple). FOLFIRINOX: FOLFIRINOX consist of the following: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (400 mg/m^2 bolus followed by 2,400 mg/m^2 continuous infusion over 46-48 hours). FOLFIRINOX will be administered over 6 cycles (Days 1 and 15 of each cycle) starting 7-28 days following completion of SBRT. Each cycle is 28 days long. | 3 | 3 | 3 | 3 | 3 | 3 |
| EG001 | Cohort 2: SBRT and Modified FOLFIRINOX | Stereotactic Body Radiation (SBRT, 6.6 Gy) will be administered over 5 days within 6-10 weeks of surgery (Whipple). FOLFIRINOX: FOLFIRINOX consist of the following: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (2,400 mg/m^2 continuous infusion over 46-48 hours). FOLFIRINOX will be administered over 6 cycles (Days 1 and 15 of each cycle) starting 7-28 days following completion of SBRT. Each cycle is 28 days long. The difference between Cohort 1 and 2 is that the Fluorouracil bolus was dropped in Cohort 2. | 3 | 4 | 1 | 4 | 4 | 4 |
| EG002 | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | Cyclophosphamide: Cyclophosphamide (CY) 200 mg/m^2 will be administered one day prior to GVAX (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence. GVAX Pancreas Vaccine: GVAX will be administered one day after CY (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence. Stereotactic Body Radiation (SBRT, 6.6 Gy) will be administered over 5 days starting between 13-17 days after the first dose of CY/GVAX. FOLFIRINOX: FOLFIRINOX consist of the following: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (2,400 mg/m^2 continuous infusion over 46-48 hours). FOLFIRINOX will be administered over 6 cycles (Days 1 and 15 of each cycle) starting 7-28 days following completion of SBRT and at least 28 days after the first vaccine. Each cycle is 28 days long. | 8 | 12 | 6 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Catheter realted infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Skin infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
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| Small intestinal obstruction, partial | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Annuloaortic ectasia | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Arthritis (gout) | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Ascities | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Blood and lymphativ system disorders, lymphadenopathy | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Blurred vision | Eye disorders | CTCAE 4.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
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| Bruising (vaccine site) | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
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| Chills | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Cold intolerance | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Concentration impairment | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Coronary arterial calcification | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Decreased breath sounds | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Dry Lips | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Edema face | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Edema limbs | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Erythema mutliforme | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Eye disorder | Eye disorders | CTCAE 4.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Fecal incontinence | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Fever | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Flu like symptoms | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Gall bladder infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
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| Gall bladder obstruction | Hepatobiliary disorders | CTCAE 4.0 | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Gastrointestinal disorders- others, specify (dark stools) | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Gynecomastia | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Hearing imaired | Ear and labyrinth disorders | CTCAE 4.0 | Systematic Assessment |
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| Hepatic infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
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| Hematoma, liver | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Hematoma, Mediport | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
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| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Joint range of motion decreased lumbar spine | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Laryngopharyngeal dysesthesia | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Lip infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Menopause | Social circumstances | CTCAE 4.0 | Systematic Assessment |
| |
| Mucoasal infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Mucositis (oral ulcers) | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pallor | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pancreatic enzymes decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Photophobia | Endocrine disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pneumobilia | Hepatobiliary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Renal Calculi | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Renal cysts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | Systematic Assessment |
| |
| Respiratory disorder - other, tracheal deviation | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Skin and Subcutaneous Tissue disorder | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Skin atrophy | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| skin discoloration | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Skin tears | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Small intestinal obstruction, partial | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Thymic hyperplasia | Immune system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vertebral compression | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Ventricular gallop | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| White blood | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
| |
| Erythema (Vaccine site) | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Induration (Vaccine Site) | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Prutitus (Vaccine site) | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Skin discoloration (Vaccine Site) | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Tenderness (Vaccine Site) | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vaccine Site Flares | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Sinus pain | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Steatosis | Hepatobiliary disorders | CTCAE 4.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Laheru, MD | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 410-955-8974 | Laherda@jhmi.edu |
| Apr 5, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D016634 | Radiosurgery |
| C000627770 | folfirinox |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG 1 |
|
| Title | Measurements |
|---|---|
|
| Thrombocytopenia |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG002 | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | Cyclophosphamide (Cy) 200 mg/m^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence. Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX. Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (2,400 mg/m^2 continuous infusion over 46-48 hours). Dose reductions were permitted. |
|
|
| OG002 | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | Cyclophosphamide (Cy) 200 mg/m^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence. Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX. Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (2,400 mg/m^2 continuous infusion over 46-48 hours). Dose reductions were permitted. |
|
|
| OG002 | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | Cyclophosphamide (Cy) 200 mg/m^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence. Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX. Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (2,400 mg/m^2 continuous infusion over 46-48 hours). Dose reductions were permitted. |
|
|
| OG002 | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | Cyclophosphamide (Cy) 200 mg/m^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence. Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX. Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (2,400 mg/m^2 continuous infusion over 46-48 hours). Dose reductions were permitted. |
|
|