A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cis... | NCT03535727 | Trialant
NCT03535727
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Status
Completed
Last Update Posted
Dec 31, 2024Actual
Enrollment
48Actual
Phase
Phase 1Phase 2
Conditions
Adenocarcinoma
Pancreatic Neoplasms
Neoplasm, Glandular
Neoplasms
Neoplasms Pancreatic
Digestive System Neoplasm
Endocrine Gland Neoplasms
Digestive System Disease
Pancreatic Diseases
Endocrine System Diseases
Interventions
Nab-paclitaxel
Gemcitabine
Capecitabine
Cisplatin
Irinotecan
Nab-paclitaxel
Gemcitabine
Capecitabine
Cisplatin
Irinotecan
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03535727
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
J1847
Secondary IDs
ID
Type
Description
Link
IRB00167664
Other Identifier
Johns Hopkins Medical Institution
Brief Title
A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer
Official Title
A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer
Acronym
Not provided
Organization
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Status Module
Record Verification Date
Dec 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 21, 2018Actual
Primary Completion Date
Oct 3, 2022Actual
Completion Date
Oct 3, 2022Actual
First Submitted Date
May 11, 2018
First Submission Date that Met QC Criteria
May 22, 2018
First Posted Date
May 24, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Sep 15, 2023
Results First Submitted that Met QC Criteria
Jan 2, 2024
Results First Posted Date
Jan 8, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 13, 2024
Last Update Posted Date
Dec 31, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic pancreatic cancer.
Detailed Description
This was a two-part, single-institution, open-label, dose-escalation, phase 1/2 study to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan in patients with metastatic pancreatic cancer.
Part 1 of the study was a Phase 1 3 + 3 dose escalation study designed to evaluate the maximally tolerated dose (MTD) and safety of increasing doses of nab-paclitaxel in combination with gemcitabine, capecitabine, cisplatin, and irinotecan. There were two cohorts of dose escalations. The two cohorts differed based on the treatment cycle length (28 days for Cohort 1 and 21 days for Cohort 2). Dose escalation started with Cohort 1. Enrollment for Cohort 2 dose level 1 began once dose level 2 of Cohort 1 was shown to be safe and did not exceed MTD.
Part 2 was a Phase 2 expansion cohort study for the evaluation of efficacy once the MTD had been determined.
Conditions Module
Conditions
Adenocarcinoma
Pancreatic Neoplasms
Neoplasm, Glandular
Neoplasms
Neoplasms Pancreatic
Digestive System Neoplasm
Endocrine Gland Neoplasms
Digestive System Disease
Pancreatic Diseases
Endocrine System Diseases
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
48Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1, Cohort 1, Dose level 1
Experimental
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 40 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Capecitabine
Drug: Cisplatin
Drug: Irinotecan
Phase 1, Cohort 1, Dose level 2
Experimental
Gemcitabine 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel 60 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID: PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Capecitabine
Drug: Cisplatin
Drug: Irinotecan
Phase 1, Cohort 1, Dose level 3
Experimental
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 80 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan:20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Capecitabine
Drug: Cisplatin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nab-paclitaxel
Drug
IV over 30 minutes; Days 1 and 15
Phase 1, Cohort 1, Dose level 1
Phase 1, Cohort 1, Dose level 2
Phase 1, Cohort 1, Dose level 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD) of Gemcitabine.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
28 days
Maximum Tolerated Dose (MTD) of Nab-paclitaxel.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Nab-paclitaxel: 20, 40, 60, 80, 100,125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
28 days
Maximum Tolerated Dose (MTD) of Capecitabine.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. Participants received Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
28 days
Maximum Tolerated Dose (MTD) of Cisplatin.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
28 days
Maximum Tolerated Dose (MTD) of Irinotecan.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
28 days
Progression-free Survival (PFS) Using RECIST 1.1 Criteria
Secondary Outcomes
Measure
Description
Time Frame
Safety of the Combination of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Patients With Untreated Metastatic PDA.
Number of patients who received the MTD (Cohort 1, Dose Level 5) that experienced a limiting toxicity. Limiting toxicity was defined as a grade 3 or above treatment-related toxicity, with the following exceptions: 1. Grade 3 anemia that resolves to < grade 2 within 7 days; 2. Grade 3 thrombocytopenia without clinically significant bleeding that resolves to < grade 2 within 7 days; 3. Grade 3 or 4 neutropenia that resolves to <grade 2 within 7 days; 4. Grade 3 or 4 leucopenia/lymphopenia; 5. Grade 3 nausea, vomiting, or diarrhea that resolves to <grade 2 within 72 hours; 6. Grade 3 or 4 asymptomatic laboratory values that resolve to < grade 2 within 7 days; 7. Grade 3 dermatologic AEs that are considered mild in severity but only considered grade 3 because of >30% body surface involvement; 8. Grade 3 fatigue lasting less than 72 hours. This study used the descriptions and grading scales found in the revised NCI CTCAE fV 5.0 for adverse event reporting.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
Patients with the presence of at least one measurable lesion.
Male or non-pregnant and non-lactating female of age >18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
Must use acceptable form of birth control while on study.
Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
Patients who will be considered for surgery are ineligible.
Patient who have had any prior chemotherapy within 5 years of enrollment.
Patient who have had radiotherapy for pancreatic cancer.
Age ≥ 76 years
Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
Patient who has known brain metastases.
Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, capecitabine, cisplatin, or irinotecan.
Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patient who has serious medical risk factors involving any of the major organ systems.
Patient who has known history of infection with HIV, hepatitis B, or hepatitis C.
Pregnant or breast feeding.
Patient is unwilling or unable to comply with study procedures
Patient with clinically significant wound.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
76 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Dung Le, MD
Johns Hopkins Medical Institution
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sidney Kimmel Comprehensive Cancer Center
Baltimore
Maryland
21231
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1, Cohort 1, Dose Level 1
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 40 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
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
Apr 8, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Irinotecan
Phase 1, Cohort 1, Dose level 4
Experimental
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:100 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine:500 PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan:20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Capecitabine
Drug: Cisplatin
Drug: Irinotecan
Phase 1, Cohort 1, Dose level 5
Experimental
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Capecitabine
Drug: Cisplatin
Drug: Irinotecan
Phase 1, Cohort 2, Dose level 1
Experimental
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:40 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Capecitabine
Drug: Cisplatin
Drug: Irinotecan
Phase 1, Cohort 2, Dose level 2
Experimental
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:60 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Capecitabine
Drug: Cisplatin
Drug: Irinotecan
Phase 1, Cohort 2, Dose level 3
Experimental
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:80 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Capecitabine
Drug: Cisplatin
Drug: Irinotecan
Phase 2 Dose Expansion (Cohort 1, DL5)
Experimental
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Capecitabine
Drug: Cisplatin
Drug: Irinotecan
Phase 1, Cohort 1, Dose level 4
Phase 1, Cohort 1, Dose level 5
Phase 2 Dose Expansion (Cohort 1, DL5)
Abraxane
Gemcitabine
Drug
IV over 30 minutes; Days 1 and 15
Phase 1, Cohort 1, Dose level 1
Phase 1, Cohort 1, Dose level 2
Phase 1, Cohort 1, Dose level 3
Phase 1, Cohort 1, Dose level 4
Phase 1, Cohort 1, Dose level 5
Phase 2 Dose Expansion (Cohort 1, DL5)
Gemzar
Capecitabine
Drug
PO twice daily (BID); Days 1-7, 15-21
Phase 1, Cohort 1, Dose level 1
Phase 1, Cohort 1, Dose level 2
Phase 1, Cohort 1, Dose level 3
Phase 1, Cohort 1, Dose level 4
Phase 1, Cohort 1, Dose level 5
Phase 2 Dose Expansion (Cohort 1, DL5)
Xeloda
Cisplatin
Drug
IV over 60 minutes; Days 1 and 15
Phase 1, Cohort 1, Dose level 1
Phase 1, Cohort 1, Dose level 2
Phase 1, Cohort 1, Dose level 3
Phase 1, Cohort 1, Dose level 4
Phase 1, Cohort 1, Dose level 5
Phase 2 Dose Expansion (Cohort 1, DL5)
Platinol
Irinotecan
Drug
IV over 30 minutes; Days 1 and 15
Phase 1, Cohort 1, Dose level 1
Phase 1, Cohort 1, Dose level 2
Phase 1, Cohort 1, Dose level 3
Phase 1, Cohort 1, Dose level 4
Phase 1, Cohort 1, Dose level 5
Phase 2 Dose Expansion (Cohort 1, DL5)
Camptosar
Nab-paclitaxel
Drug
IV over 30 minutes; Days 4 and 11
Phase 1, Cohort 2, Dose level 1
Phase 1, Cohort 2, Dose level 2
Phase 1, Cohort 2, Dose level 3
Abraxane
Gemcitabine
Drug
IV over 30 minutes; Days 4 and 11
Phase 1, Cohort 2, Dose level 1
Phase 1, Cohort 2, Dose level 2
Phase 1, Cohort 2, Dose level 3
Gemzar
Capecitabine
Drug
PO BID; Days 1- 14
Phase 1, Cohort 2, Dose level 1
Phase 1, Cohort 2, Dose level 2
Phase 1, Cohort 2, Dose level 3
Xeloda
Cisplatin
Drug
IV over 60 minutes; Days 4 and 11
Phase 1, Cohort 2, Dose level 1
Phase 1, Cohort 2, Dose level 2
Phase 1, Cohort 2, Dose level 3
Platinol
Irinotecan
Drug
IV over 30 minutes; Days 4 and 11
Phase 1, Cohort 2, Dose level 1
Phase 1, Cohort 2, Dose level 2
Phase 1, Cohort 2, Dose level 3
Camptosar
PFS is defined as the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
27 months
27 months
FG001
Phase 1, Cohort 1, Dose Level 2
Gemcitabine 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel 60 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID: PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
FG002
Phase 1, Cohort 1, Dose Level 3
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 80 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan:20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
FG003
Phase 1, Cohort 1, Dose Level 4
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:100 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine:500 PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan:20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
FG004
Phase 1, Cohort 1, Dose Level 5
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
FG005
Phase 1, Cohort 2, Dose Level 1
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:40 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
FG006
Phase 1, Cohort 2, Dose Level 2
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:60 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
FG007
Phase 1, Cohort 2, Dose Level 3
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:80 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
FG008
Phase 2 MTD Dose Expansion
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
FG0003 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0053 subjects
FG0063 subjects
FG0077 subjects
FG0088 subjects
COMPLETED
FG0003 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0053 subjects
FG0063 subjects
FG0077 subjects
FG0088 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1, Cohort 1, Dose Level 1
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 40 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
BG001
Phase 1, Cohort 1, Dose Level 2
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 60 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
BG002
Phase 1, Cohort 1, Dose Level 3
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 80 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
BG003
Phase 1, Cohort 1, Dose Level 4
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 100 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
BG004
Phase 1, Cohort 1, Dose Level 5
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
BG005
Phase 1, Cohort 2, Dose Level 1
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:40 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
BG006
Phase 1, Cohort 2, Dose Level 2
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:60 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
BG007
Phase 1, Cohort 2, Dose Level 3
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:80 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
BG008
Phase 2, MTD Dose Expansion
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0016
BG0026
BG0036
BG0046
BG0053
BG0063
BG0077
BG0088
BG00948
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0016
BG002
Eastern Cooperative Oncology Group (ECOG)
The ECOG scale measures performance status , which 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 tp bed/chair,5= deceased
Count of Participants
Participants
Title
Denominators
Categories
ECOG 0
Title
Measurements
BG0000
BG001
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
Maximum Tolerated Dose (MTD) of Gemcitabine.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Cohort 1 cycle schedule was selected for the MTD (Days 1 and 15 of a 28 day cycle)
Posted
Number
mg/m^2
28 days
ID
Title
Description
OG000
Phase I
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Nab-paclitaxel:20, 40, 60, 80, 100,125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Units
Counts
Participants
OG00040
Title
Denominators
Categories
Title
Measurements
OG000500
Primary
Maximum Tolerated Dose (MTD) of Nab-paclitaxel.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Nab-paclitaxel: 20, 40, 60, 80, 100,125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Cohort 1 cycle schedule was selected for the MTD (Days 1 and 15 of a 28 day cycle)
Posted
Number
mg/m^2
28 days
ID
Title
Description
OG000
Phase 1
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Nab-paclitaxel:20, 40, 60, 80, 100,125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Units
Counts
Participants
Primary
Maximum Tolerated Dose (MTD) of Capecitabine.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. Participants received Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
Cohort 1 cycle schedule was selected for the MTD (Days 1-7 and 15-21 of a 28 day cycle)
Posted
Number
mg BID
28 days
ID
Title
Description
OG000
Phase I
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Nab-paclitaxel:20, 40, 60, 80, 100,125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Units
Counts
Participants
Primary
Maximum Tolerated Dose (MTD) of Cisplatin.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Cohort 1 cycle schedule was selected for the MTD (Days 1 and 15 of a 28 day cycle)
Posted
Number
mg/m^2
28 days
ID
Title
Description
OG000
Phase 1
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Nab-paclitaxel:20, 40, 60, 80, 100,125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Units
Counts
Participants
OG000
Primary
Maximum Tolerated Dose (MTD) of Irinotecan.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Cohort 1 cycle schedule was selected for the MTD (Days 1 and 15 of a 28 day cycle)
Posted
Number
mg/m^2
28 days
ID
Title
Description
OG000
Phase 1
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Nab-paclitaxel:20, 40, 60, 80, 100,125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Units
Counts
Participants
OG000
Primary
Progression-free Survival (PFS) Using RECIST 1.1 Criteria
PFS is defined as the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Per the clinical trial design, PFS analyses included all subjects who received the MTD (Cohort 1, Dose Level 5). Since the enrollment criteria and dose are the same, combining those who are treated at MTD at both phases increase the power and enable to estimate the treatment effect with increased precision. This included the 6 subjects enrolled in the Phase 1 portion of the trial and the 8 subjects enrolled in the Phase 2 portion of the trial for a total of 14 subjects.
Posted
Median
95% Confidence Interval
months
27 months
ID
Title
Description
OG000
Phase 1 MTD/ Phase 2
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Secondary
Safety of the Combination of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Patients With Untreated Metastatic PDA.
Number of patients who received the MTD (Cohort 1, Dose Level 5) that experienced a limiting toxicity. Limiting toxicity was defined as a grade 3 or above treatment-related toxicity, with the following exceptions: 1. Grade 3 anemia that resolves to < grade 2 within 7 days; 2. Grade 3 thrombocytopenia without clinically significant bleeding that resolves to < grade 2 within 7 days; 3. Grade 3 or 4 neutropenia that resolves to <grade 2 within 7 days; 4. Grade 3 or 4 leucopenia/lymphopenia; 5. Grade 3 nausea, vomiting, or diarrhea that resolves to <grade 2 within 72 hours; 6. Grade 3 or 4 asymptomatic laboratory values that resolve to < grade 2 within 7 days; 7. Grade 3 dermatologic AEs that are considered mild in severity but only considered grade 3 because of >30% body surface involvement; 8. Grade 3 fatigue lasting less than 72 hours. This study used the descriptions and grading scales found in the revised NCI CTCAE fV 5.0 for adverse event reporting.
Per the clinical trial design, safety analyses included all subjects who received the MTD (Cohort 1, Dose Level 5). Since the enrollment criteria and dose are the same, combining those who are treated at MTD at both phases enable to estimate the toxicity rate with increased precision. This included the 6 subjects enrolled in the Phase 1 portion of the trial and the 8 subjects enrolled in the Phase 2 portion of the trial for a total of 14 subjects.
Posted
Count of Participants
Participants
27 months
ID
Title
Description
OG000
Phase 1 MTD/ Phase 2
Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Time Frame
All-Cause Mortality was assessed for up to 51 months for patients in both Phase 1 and Phase 2 portions of the trial. Serious and Other (Not Including Serious) Adverse Events were assessed up to 45 months for patients in both Phase 1 and 2 portions of the trial.
Description
This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1, Cohort 1, Dose Level 1
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 40 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
3
3
0
3
3
3
EG001
Phase 1, Cohort 1, Dose Level 2
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 60 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
6
6
2
6
6
6
EG002
Phase 1, Cohort 1, Dose Level 3
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 80 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
5
6
5
6
6
6
EG003
Phase 1, Cohort 1, Dose Level 4
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 100 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
6
6
2
6
6
6
EG004
Phase 1, Cohort 1, Dose Level 5
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
6
6
4
6
6
6
EG005
Phase 1, Cohort 2, Dose Level 1
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:40 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
3
3
1
3
3
3
EG006
Phase 1, Cohort 2, Dose Level 2
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:60 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
3
3
2
3
3
3
EG007
Phase 1, Cohort 2, Dose Level 3
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:80 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
7
7
2
7
7
7
EG008
Phase 2 MTD Dose Expansion
Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
7
8
4
8
8
8
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected8 at risk
Atrial fibrillation
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Myocardial infarction
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Colonic obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Esophageal varices hemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Hematemesis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pancreatitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Fever
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Disease progression-Death
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Biliary tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Enterocolitis infectious
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pseudocyst infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Liver abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Presyncope
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Stroke
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Pleural hemorrhage
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Thromboembolic event
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG00113 events3 affected6 at risk
EG0029 events3 affected6 at risk
EG0032 events1 affected6 at risk
EG00411 events2 affected6 at risk
EG00511 events2 affected3 at risk
EG00624 events2 affected3 at risk
EG00721 events6 affected7 at risk
EG0081 events1 affected8 at risk
Swollen gland
Blood and lymphatic system disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain - cardiac
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sinus bradycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0023 events2 affected6 at risk
EG003
Feeling of water/air in right ear
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Thyromegaly
Endocrine disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blurred vision
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cataract
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dry eye
Eye disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eye pain
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Floaters
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Periorbital edema
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vision decreased
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Watering eyes
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Double vision
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctival chalsis
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Transient eye yellowing
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0025 events2 affected6 at risk
EG003
Bloating
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Cheilitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Diarrhea
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0024 events2 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fecal incontinence
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events3 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hemorrhoids
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Mucositis oral
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected6 at risk
EG0024 events3 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Stomach pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
White coating on tongue
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Discolored tongue
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tongue swollen
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Black stools
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Early satiety
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Stool discoloration
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Loose tooth
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dumping after meals
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Stools light and floating
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Increased saliva
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Edema face
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Edema limbs
General disorders
Systematic Assessment
EG0003 events1 affected3 at risk
EG0014 events3 affected6 at risk
EG0023 events3 affected6 at risk
EG003
Facial pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Fever
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0024 events2 affected6 at risk
EG003
Gait disturbance
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypothermia
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Malaise
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events2 affected6 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hepatosplenomegaly
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Liver Cirrhosis
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Allergic reaction
Immune system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bronchial infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Enterocolitis infectious
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Herpes simplex reactivation
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Laryngitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lung infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Otitis media
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Peritoneal infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Thrush
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Upper respiratory infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Bruising
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0022 events1 affected6 at risk
EG003
Fracture spinal
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected6 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected6 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Alkaline phosphatase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood bilirubin increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Creatinine increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
International Normalized Ratio increase
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cocaine metabolite
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lipase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG00210 events1 affected6 at risk
EG003
Neutrophil count decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0026 events1 affected6 at risk
EG003
Platelet count decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events1 affected6 at risk
EG003
Urine output decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Weight gain
Investigations
Systematic Assessment
EG0002 events1 affected3 at risk
EG0018 events3 affected6 at risk
EG0025 events2 affected6 at risk
EG003
Weight loss
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected6 at risk
EG0025 events3 affected6 at risk
EG003
White blood cell decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0025 events1 affected6 at risk
EG003
Acidosis
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Anorexia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkalemia
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected6 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected6 at risk
EG0025 events2 affected6 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG00113 events4 affected6 at risk
EG0025 events4 affected6 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events1 affected6 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events2 affected6 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscle cramp
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pseudo gout
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Jaw pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Neck pain
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremities
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Cognitive disturbance
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Concentration impairment
Nervous system disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Memory impairment
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Aura
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cold sensitivity
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Jitteriness
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eye twitch
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Paresthesia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events2 affected6 at risk
EG0024 events3 affected6 at risk
EG003
Presyncope
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Seizure
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Stroke
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Transient ischemic attacks
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tremor
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Agitation
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Confusion
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Delirium
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Depression
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hematuria
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Renal cysts
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Renal dysfunction
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Renal calculi
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urinary frequency
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urinary urgency
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urine discoloration
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Allergic rhinitis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events2 affected6 at risk
EG0023 events2 affected6 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Hoarseness
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Pleural hemorrhage
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bradypnea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Tachypnea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected6 at risk
EG003
Sinus drainage
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinorrhea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Sore throat
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0013 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Voice alteration
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0013 events3 affected6 at risk
EG0025 events4 affected6 at risk
EG003
Dry skin
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected6 at risk
EG003
Nail changes
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nail discoloration
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Palmar-plantar erythrodysesthesia syndrome
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Rash acneiform
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Rash pustular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Skin atrophy
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin ulceration
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lipoma and other skin nodules
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arterial thromboembolism
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Flushing
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hematoma
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hot flashes
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
Systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events1 affected6 at risk
EG003
Hypotension
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0023 events2 affected6 at risk
EG003
Thromboembolic event
Vascular disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Fungal foot Infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Liver abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cold sore
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sternal pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin abrasions and injuries
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Rash acne form
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Redness and skin sensitivity
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Venous stasis dermatitis of lower extremities
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Drop foot
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Dung Le, M.D.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins