APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma
Official Title
A Phase I/Ib Study of APX005M in Combination With Nivolumab and Cabiralizumab in Patients With Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma Whose Disease Has Progressed on Anti-PD- 1/PD-L1 Therapy
Acronym
Not provided
Organization
Yale UniversityOTHER
Status Module
Record Verification Date
Jun 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 9, 2018Actual
Primary Completion Date
Jan 5, 2022Actual
Completion Date
May 15, 2024Actual
First Submitted Date
Mar 29, 2018
First Submission Date that Met QC Criteria
Apr 10, 2018
First Posted Date
Apr 18, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jul 27, 2023
Results First Submitted that Met QC Criteria
Aug 14, 2023
Results First Posted Date
Aug 18, 2023Actual
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
Jun 21, 2024
Last Update Posted Date
Jul 3, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Yale UniversityOTHER
Collaborators
Name
Class
Bristol-Myers Squibb
INDUSTRY
Apexigen America, Inc.
INDUSTRY
National Cancer Institute (NCI)
NIH
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This trial is a phase 1/1b study to evaluate the safety, efficacy, and tolerability of APX005M in combination with nivolumab and cabiralizumab.
The phase 1 dose escalation portion of the study will enroll patients with advanced solid tumors melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC) in 6 cohorts to determine the recommended phase II dose (RP2D) of APX005M.
The phase 1b dose expansion portion will study the triple drug combination separately in the three disease cohorts: melanoma, NSCLC, and RCC.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Melanoma
Non-small Cell Lung Cancer
Renal Cell Carcinoma
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
42Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1 Advanced Solid Tumors
Experimental
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
Drug: APX005M
Drug: Cabiralizumab
Cohort 2 Advanced Solid Tumors
Experimental
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
Drug: APX005M
Drug: Cabiralizumab
Drug: Nivolumab
Cohort 3 Advanced Solid Tumors
Experimental
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
Drug: APX005M
Drug: Cabiralizumab
Cohort 4 Advanced Solid Tumors
Experimental
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
Drug: APX005M
Drug: Cabiralizumab
Drug: Nivolumab
Cohort 5 Advanced Solid Tumors
Experimental
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
Drug: APX005M
Interventions
Name
Type
Description
Arm Group Labels
Other Names
APX005M
Drug
APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety and Tolerability Measured by Assessing Serious Adverse Events (SAEs)and Adverse Events (AEs)
AEs and SAEs will be examined with (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03.
From study enrollment up to 12 months.
Safety and Tolerability Measured by Eastern Cooperative Oncology Group(ECOG) Performance Status
This 5-point scale ranges from full functioning (0) to dead (5)
From study enrollment up to 12 months.
Secondary Outcomes
Measure
Description
Time Frame
Efficacy Measured by Objective Response Rate (ORR)
ORR will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v. 1.1. The RECIST categories used for the target lesion are complete response (CR), partial response (PR), stable disease (NR/SD), and progressive disease (PD).
Six months.
Other Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK) of APX005M Assessed by Area Under the Curve (AUC).
This outcome will be assessed by blood collection.
12 weeks
Pharmacokinetics (PK) of APX005M Assessed by Minimum Blood Plasma Concentration (Cmin).
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must have one of the following diagnoses:
Melanoma: Unresectable stage III or stage IV melanoma, irrespective of BRAF status, with histologic or cytologic confirmation.
RCC: Histologic or cytologically documented, locally advanced unresectable or metastatic RCC irrespective of histologic subtype
NSCLC: Histologic or cytologically documented, locally advanced or metastatic (i.e. Stage IIIB not eligible for definitive chemoradiotherapy, stage IV, or recurrent) NSCLC. Patients known to harbor an ALK rearrangement or EGFR mutation known to be sensitive to FDA-approved tyrosine kinase inhibitors (TKI), are only eligible after experiencing disease progression (during or after treatment) or intolerance to an FDA approved ALK TKI or EGFR TKI, respectively. Patients with TKI-treated EGFR mutant NSCLC harboring the secondary EGFR T790M tumor must have received prior osimertinib. Patients with crizotinib-treated ALK rearranged NSCLC must have received a next generation ALK inhibitor.
Additional Inclusion Criteria:
Biopsy proven metastatic melanoma, NSCLC or RCC whose disease has progressed on a prior regimen containing a PD-1 or PD-L1 inhibitor, without intervening therapy.
At least 1 site of disease must be accessible to provide repeat biopsies for tumor tissue. This site may be a target lesion as long as it will not be made unmeasurable by the biopsy procedure.
Age ≥18, able to understand and sign the informed consent form.
ECOG performance status < 2.
Any number of previous treatments. Other prior systemic therapies must have been administered at least 4 weeks before administration of the study drugs; the exception to this is small molecule inhibitors, which must be stopped at least 2 weeks or after five half-lives of the drug, whichever is shorter, prior to the start of the study drugs.
Life expectancy of at least 6 months.
A history of previously treated brain metastases is allowed, provided that they are stable for at least 4 weeks.
Willingness to undergo mandatory tumor biopsy prior to initiation of therapy and before the fifth cycle.
Willingness to provide an archival specimen block, if available, for research.
Patients must have normal organ and marrow function (as outlined in Section 3.2.2).
Female subject of childbearing potential should have a negative urine or serum pregnancy within 24 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential should be willing to use a highly effective contraception (hormonal or IUD) or be surgically sterile, or abstain from heterosexual activity for a period of at least 5 months after the last dose of study drug. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through at least 7 months after the last dose of study drug.
Patients must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST v1.1 criteria.
a. Tumor sites situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are not considered measurable unless there has been demonstrated progression in the lesion. Sites for biopsy must be distinct from target lesions used for efficacy assessment.
Prior focal radiotherapy is allowed. Radiation to brain, pulmonary or intestinal sites must be completed at least 4 weeks prior to study Day 1. There is no time restriction prior to study Day 1 for patients who have received radiation to bone, soft tissue or other sites. No radiopharmaceuticals (strontium, samarium) within 8 weeks before first dose of study drug administration.
Prior surgery that requires general anesthesia must be completed at least 1 week before first dose of study drug administration. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before first dose of study drug administration and patients should have recovered.
Exclusion Criteria:
Untreated brain metastases.
A patient who has had prior immune therapy or chemotherapy, within 4 weeks prior to study Day 1, or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent will be excluded. The exception is targeted therapy that must have been completed at least 2 weeks or after 5 half-lives, which ever is shorter, prior to study Day 1. Patients who have had prior ipilimumab must have received their last dose no less than 4 weeks prior to study Day 1.
Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Note: Toxicity that has not recovered to ≤ Grade 1 is allowed if it meets the inclusion requirements for laboratory parameters.
Has had prior treatment with any other CSF1R inhibitor or CD40 agonist
Use of corticosteroids to control immune related adverse events at enrollment will not be allowed, and patients who previously required corticosteroids for symptom control must be off steroids for at least 2 weeks. Low-dose steroid use (≤10 mg of prednisone or equivalent) as corticosteroid replacement therapy for primary or secondary adrenal insufficiency is allowed.
Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to prior treatments with the exception of clinically insignificant adverse events such as alopecia, clinically insignificant laboratory abnormalities, clinically insignificant rash and Grade 2 neuropathy.
History of grade 3-4 neurologic or cardiac toxicity or life-threatening liver toxicity poorly responsive to steroids with prior anti-PD-1/anti-PDL1 monotherapy.
Presence of leptomeningeal disease.
Has active autoimmune disease unrelated to use of immune checkpoint inhibitors that has required systemic treatment in the past year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Pregnancy or breast feeding. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab, cabiralizumab or APX005M, breastfeeding must be discontinued if the mother is enrolled on this trial.
Patients may not be receiving any other investigational agents and may not have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
Either a concurrent condition (including medical illness, such as active infection requiring treatment with intravenous antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or a medical condition that confounds the ability to interpret data from the study.
Concurrent, active malignancies in addition to those being studied.
Active (non-infectious) pneumonitis.
Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) acute or chronic infection.
Has received a live vaccine within 30 days prior to the first dose of trial treatment.
History of myocardial infarction or unstable angina within 3 months prior to Cycle 1, Day 1.
Prisoners, or subjects who are under compulsory detention
Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels
History of anti-drug antibodies, severe allergic, anaphylactic, or other infusion-related reaction to a previous biologic agent
Concomitant use of statins while on study. However, a patient using statins for over 3 months prior to study drug administration and in stable status without CK rise may be permitted to enroll
Open wounds and active skin infections
Uveal melanoma in the Phase Ib dose expansion trial
Djureinovic D, Weiss SA, Krykbaeva I, Qu R, Vathiotis I, Moutafi M, Zhang L, Perdigoto AL, Wei W, Anderson G, Damsky W, Hurwitz M, Johnson B, Schoenfeld D, Mahajan A, Hsu F, Miller-Jensen K, Kluger Y, Sznol M, Kaech SM, Bosenberg M, Jilaveanu LB, Kluger HM. A bedside to bench study of anti-PD-1, anti-CD40, and anti-CSF1R indicates that more is not necessarily better. Mol Cancer. 2023 Nov 14;22(1):182. doi: 10.1186/s12943-023-01884-x.
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
FG001
Cohort 2 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
FG002
Cohort 3 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
FG003
Cohort 4 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
FG004
Cohort 5 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
FG005
Cohort 6 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
FG006
Cohort 7 Advanced Melanoma
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
FG007
Cohort 8 NSCLC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
FG008
Cohort 9 RCC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
THIS STUDY ARM/COHORT WAS NEVER ACTIVATED DURING THE STUDY.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0035 subjects
FG0043 subjects
FG0056 subjects
FG0068 subjects
FG0078 subjects
FG0080 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0035 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Safety and Tolerability Measured by Assessing Serious Adverse Events (SAEs)and Adverse Events (AEs)
AEs and SAEs will be examined with (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03.
Posted
Count of Participants
Participants
From study enrollment up to 12 months.
ID
Title
Description
OG000
Cohort 1 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
OG001
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 12 months
Description
Not provided
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
Cohort 1 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
Yes
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Harriet Kluger, MD
Harvey and Kate Cushing Professor of Medicine (Oncology) and of Dermatology; Director, Yale SPORE in Skin Cancer, Yale Cancer Center
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
Drug: APX005M
Drug: Cabiralizumab
Drug: Nivolumab
Cohort 7 Advanced Melanoma
Experimental
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
Drug: APX005M
Drug: Cabiralizumab
Drug: Nivolumab
Cohort 8 NSCLC
Experimental
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
Drug: APX005M
Drug: Cabiralizumab
Cohort 9 RCC
Experimental
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
Drug: APX005M
Drug: Cabiralizumab
Drug: Nivolumab
Cohort 1 Advanced Solid Tumors
Cohort 2 Advanced Solid Tumors
Cohort 3 Advanced Solid Tumors
Cohort 4 Advanced Solid Tumors
Cohort 5 Advanced Solid Tumors
Cohort 6 Advanced Solid Tumors
Cohort 7 Advanced Melanoma
Cohort 8 NSCLC
Cohort 9 RCC
Cabiralizumab
Drug
Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Cohort 1 Advanced Solid Tumors
Cohort 2 Advanced Solid Tumors
Cohort 3 Advanced Solid Tumors
Cohort 4 Advanced Solid Tumors
Cohort 5 Advanced Solid Tumors
Cohort 6 Advanced Solid Tumors
Cohort 7 Advanced Melanoma
Cohort 8 NSCLC
Cohort 9 RCC
Nivolumab
Drug
Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
Cohort 2 Advanced Solid Tumors
Cohort 4 Advanced Solid Tumors
Cohort 6 Advanced Solid Tumors
Cohort 7 Advanced Melanoma
Cohort 9 RCC
This outcome will be assessed by blood collection.
12 weeks
Pharmacokinetics (PK) of APX005M Assessed by Clearance (CL).
This outcome will be assessed by blood collection.
12 weeks
Pharmacokinetics (PK) of APX005M Assessed by Volume of Distribution (Vss)
This outcome will be assessed by blood collection.
12 weeks
Pharmacokinetics (PK) of APX005M Assessed by Peak Plasma Concentration (Cmax).
This outcome will be assessed by blood collection.
12 weeks
Tissue-based Pharmacodynamics (PD) of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by CD8+ T Cells .
This outcome will be assessed with tissue biopsies.
Change from baseline to 8 weeks.
Tissue-based Pharmacodynamics (PD) of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by CD163+ Macrophages .
This outcome will be assessed with tissue biopsies.
Change from baseline to 8 weeks.
Blood-based Pharmacodynamics (PD) of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by Circulating CD163+ Macrophages .
This outcome will be assessed via blood collection.
Change from baseline to 8 weeks.
Blood-based Pharmacodynamics (PD) of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by Circulating CD8+ T Cells.
This outcome will be assessed via blood collection.
Change from baseline to 8 weeks.
Cytokine-based Pharmacodynamic (PD) Biomarkers of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by CD40L Levels.
This outcome will be assessed via blood collection.
Change from baseline to 8 weeks.
Cytokine-based Pharmacodynamic (PD) Biomarkers of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by IL-10 Levels.
This outcome will be assessed via blood collection.
Change from baseline to 8 weeks.
Cytokine-based Pharmacodynamic (PD) Biomarkers of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by Interferon-gamma Levels .
This outcome will be assessed via blood collection.
Change from baseline to 8 weeks.
Efficacy Measured by Progression-free Survival (PFS)
PFS will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v. 1.1.
From study enrollment up to 6 years.
Efficacy Measured by Overall Survival (OS)
OS will be ascertained by review of the National Death Index, medical records and follow-up phone calls.
From study enrollment up to 6 years.
Weiss SA, Djureinovic D, Jessel S, Krykbaeva I, Zhang L, Jilaveanu L, Ralabate A, Johnson B, Levit NS, Anderson G, Zelterman D, Wei W, Mahajan A, Trifan O, Bosenberg M, Kaech SM, Perry CJ, Damsky W, Gettinger S, Sznol M, Hurwitz M, Kluger HM. A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non-Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1. Clin Cancer Res. 2021 Sep 1;27(17):4757-4767. doi: 10.1158/1078-0432.CCR-21-0903. Epub 2021 Jun 17.
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
3 subjects
FG0056 subjects
FG0068 subjects
FG0078 subjects
FG0080 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
Lack of Efficacy
FG0001 subjects
FG0015 subjects
FG0023 subjects
FG0035 subjects
FG0041 subjects
FG0055 subjects
FG0065 subjects
FG0076 subjects
FG0080 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Withdrawal by Subject
FG0000 subjects
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FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
Death
FG0000 subjects
FG0010 subjects
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FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
BG001
Cohort 2 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
BG002
Cohort 3 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
BG003
Cohort 4 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
BG004
Cohort 5 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
BG005
Cohort 6 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
BG006
Cohort 7 Advanced Melanoma
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
BG007
Cohort 8 NSCLC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
BG008
Total
Total of all reporting groups
3
BG0016
BG0023
BG0035
BG0043
BG0056
BG0068
BG0078
BG00842
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00061(59 to 66)
BG00158(40 to 71)
BG00269(69 to 73)
BG00358(40 to 63)
BG00461(60 to 67)
BG00561(44 to 84)
BG00665.5(55 to 73)
BG00760.5(47 to 67)
BG00861(40 to 84)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0012
BG0022
BG0030
BG0040
BG0052
BG0064
BG0072
BG00812
Male
BG0003
BG0014
BG0021
BG0035
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0003
BG0015
BG0023
BG0035
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0011
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0016
BG0023
BG0035
BG0043
BG0056
BG0068
BG0078
BG00842
ECOG PS
ECOG PS, Eastern Cooperative Oncology Group performance status is a scale that measures one's level of functioning in terms of ability to care for oneself, daily activity, and physical ability (walking, working, etc.) with a range of 0 to 5. A score of 0 indicates performance without restriction whereas a score of 5 indicates death (a higher score indicates worse functioning).
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
0
BG0003
BG0014
BG0022
BG0035
BG0041
BG0054
BG0066
BG0072
BG00827
1
BG0000
BG0012
BG0021
BG0030
BG004
2
BG0000
BG0010
BG0020
BG0030
BG004
3
BG0000
BG0010
BG0020
BG0030
BG004
4
BG0000
BG0010
BG0020
BG0030
BG004
5
BG0000
BG0010
BG0020
BG0030
BG004
Cancer Type
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Melanoma
BG0000
BG0012
BG0022
BG0033
BG0040
BG0055
BG0068
BG0070
BG00820
Renal Cell Carcinoma (RCC)
BG0003
BG0014
BG0021
BG0032
BG004
Non-small-cell Lung Cancer (NSCLC)
BG0000
BG0010
BG0020
BG0030
BG004
Cohort 2 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG002
Cohort 3 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
OG003
Cohort 4 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG004
Cohort 5 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
OG005
Cohort 6 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG006
Cohort 7 Advanced Melanoma
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG007
Cohort 8 NSCLC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0035
OG0043
OG0056
OG0068
OG0078
Title
Denominators
Categories
Experienced any SAE
Title
Measurements
OG0001
OG0013
OG0022
OG0032
OG0042
OG0055
OG0063
OG0075
Experienced any AE
Title
Measurements
OG0003
OG0016
OG0023
OG003
Primary
Safety and Tolerability Measured by Eastern Cooperative Oncology Group(ECOG) Performance Status
This 5-point scale ranges from full functioning (0) to dead (5)
Posted
Count of Participants
Participants
From study enrollment up to 12 months.
ID
Title
Description
OG000
Cohort 1 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
OG001
Cohort 2 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG002
Cohort 3 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
OG003
Cohort 4 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG004
Cohort 5 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
OG005
Cohort 6 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG006
Cohort 7 Advanced Melanoma
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG007
Cohort 8 NSCLC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
0
OG0001
OG0014
OG0022
OG003
Secondary
Efficacy Measured by Objective Response Rate (ORR)
ORR will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v. 1.1. The RECIST categories used for the target lesion are complete response (CR), partial response (PR), stable disease (NR/SD), and progressive disease (PD).
Only participants that completed at least 1 follow up assessment.
Posted
Count of Participants
Participants
Six months.
ID
Title
Description
OG000
Cohort 1 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
OG001
Cohort 2 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG002
Cohort 3 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
OG003
Cohort 4 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG004
Cohort 5 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
OG005
Cohort 6 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG006
Cohort 7 Advanced Melanoma
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
OG007
Cohort 8 NSCLC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
complete response (CR)
OG0000
OG0010
OG0020
OG003
Other Pre-specified
Pharmacokinetics (PK) of APX005M Assessed by Area Under the Curve (AUC).
This outcome will be assessed by blood collection.
Not Posted
12 weeks
Participants
Other Pre-specified
Pharmacokinetics (PK) of APX005M Assessed by Minimum Blood Plasma Concentration (Cmin).
This outcome will be assessed by blood collection.
Not Posted
12 weeks
Participants
Other Pre-specified
Pharmacokinetics (PK) of APX005M Assessed by Clearance (CL).
This outcome will be assessed by blood collection.
Not Posted
12 weeks
Participants
Other Pre-specified
Pharmacokinetics (PK) of APX005M Assessed by Volume of Distribution (Vss)
This outcome will be assessed by blood collection.
Not Posted
12 weeks
Participants
Other Pre-specified
Pharmacokinetics (PK) of APX005M Assessed by Peak Plasma Concentration (Cmax).
This outcome will be assessed by blood collection.
Not Posted
12 weeks
Participants
Other Pre-specified
Tissue-based Pharmacodynamics (PD) of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by CD8+ T Cells .
This outcome will be assessed with tissue biopsies.
Not Posted
Change from baseline to 8 weeks.
Participants
Other Pre-specified
Tissue-based Pharmacodynamics (PD) of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by CD163+ Macrophages .
This outcome will be assessed with tissue biopsies.
Not Posted
Change from baseline to 8 weeks.
Participants
Other Pre-specified
Blood-based Pharmacodynamics (PD) of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by Circulating CD163+ Macrophages .
This outcome will be assessed via blood collection.
Not Posted
Change from baseline to 8 weeks.
Participants
Other Pre-specified
Blood-based Pharmacodynamics (PD) of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by Circulating CD8+ T Cells.
This outcome will be assessed via blood collection.
Not Posted
Change from baseline to 8 weeks.
Participants
Other Pre-specified
Cytokine-based Pharmacodynamic (PD) Biomarkers of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by CD40L Levels.
This outcome will be assessed via blood collection.
Not Posted
Change from baseline to 8 weeks.
Participants
Other Pre-specified
Cytokine-based Pharmacodynamic (PD) Biomarkers of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by IL-10 Levels.
This outcome will be assessed via blood collection.
Not Posted
Change from baseline to 8 weeks.
Participants
Other Pre-specified
Cytokine-based Pharmacodynamic (PD) Biomarkers of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by Interferon-gamma Levels .
This outcome will be assessed via blood collection.
Not Posted
Change from baseline to 8 weeks.
Participants
Other Pre-specified
Efficacy Measured by Progression-free Survival (PFS)
PFS will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v. 1.1.
Not Posted
From study enrollment up to 6 years.
Participants
Other Pre-specified
Efficacy Measured by Overall Survival (OS)
OS will be ascertained by review of the National Death Index, medical records and follow-up phone calls.
Not Posted
From study enrollment up to 6 years.
Participants
0
3
1
3
3
3
EG001
Cohort 2 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
0
6
3
6
6
6
EG002
Cohort 3 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
0
3
2
3
3
3
EG003
Cohort 4 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
5
5
2
5
5
5
EG004
Cohort 5 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
0
3
2
3
3
3
EG005
Cohort 6 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
0
6
5
6
6
6
EG006
Cohort 7 Advanced Melanoma
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
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EG007
Cohort 8 NSCLC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
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EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0042 events1 affected3 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Myocarditis
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0053 events2 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Gastric hemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Fatigue
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Fever
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected8 at risk
Lung infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0032 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected8 at risk
Meningitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Periorbital infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Skin infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Blood bilirubin increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
CPK increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Platelet count decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Hypocalcemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Paresthesia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Spinal cord compression
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Stroke
Nervous system disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Hematuria
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Adult respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Dyspnea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0072 events1 affected8 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Thromboembolic event
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
EG0003 events2 affected3 at risk
EG00124 events6 affected6 at risk
EG0023 events2 affected3 at risk
EG00315 events3 affected5 at risk
EG00411 events3 affected3 at risk
EG00522 events5 affected6 at risk
EG00622 events5 affected8 at risk
EG0071 events1 affected8 at risk
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Atrial flutter
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Cardiac disorders - Other, specify
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Sinus tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Ear and labyrinth disorders - Other, specify
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Ear pain
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Hearing impaired
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Hyperthyroidism
Endocrine disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Hypothyroidism
Endocrine disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected8 at risk
Dry eye
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Eye disorders - Other, specify
Eye disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0072 events2 affected8 at risk
Eye pain
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Periorbital edema
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0063 events3 affected8 at risk
EG0078 events4 affected8 at risk
Uveitis
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Watering eyes
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected8 at risk
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0052 events2 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0063 events3 affected8 at risk
EG0072 events2 affected8 at risk
Diarrhea
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected3 at risk
EG0030 events0 affected5 at risk
EG0042 events1 affected3 at risk
EG0051 events1 affected6 at risk
EG0062 events2 affected8 at risk
EG00710 events3 affected8 at risk
Dry mouth
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected8 at risk
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0072 events2 affected8 at risk
Dysphagia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Gastric ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Gastroesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Gastrointestinal disorders - Other, specify
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Mucositis oral
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0003 events2 affected3 at risk
EG0012 events2 affected6 at risk
EG0022 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0043 events2 affected3 at risk
EG0052 events2 affected6 at risk
EG0063 events3 affected8 at risk
EG00712 events6 affected8 at risk
Oral pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0042 events1 affected3 at risk
EG0051 events1 affected6 at risk
EG0062 events2 affected8 at risk
EG0074 events3 affected8 at risk
Chills
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0042 events2 affected3 at risk
EG0054 events4 affected6 at risk
EG0064 events4 affected8 at risk
EG0078 events4 affected8 at risk
Edema face
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events2 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Edema limbs
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Fatigue
General disorders
Systematic Assessment
EG0004 events3 affected3 at risk
EG0012 events2 affected6 at risk
EG0023 events2 affected3 at risk
EG0034 events4 affected5 at risk
EG0042 events2 affected3 at risk
EG0055 events5 affected6 at risk
EG0068 events6 affected8 at risk
EG00717 events7 affected8 at risk
Fever
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events2 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0044 events3 affected3 at risk
EG0051 events1 affected6 at risk
EG0066 events5 affected8 at risk
EG0072 events2 affected8 at risk
Flu like symptoms
General disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
General disorders and administration site conditions - Other, specify
General disorders
Systematic Assessment
EG0004 events2 affected3 at risk
EG0014 events2 affected6 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0073 events1 affected8 at risk
Infusion related reaction
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Pain
General disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0044 events2 affected3 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected8 at risk
EG0073 events3 affected8 at risk
Hepatobiliary disorders - Other, specify
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG0033 events2 affected5 at risk
EG0041 events1 affected3 at risk
EG0052 events2 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Cytokine release syndrome
Immune system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Infections and infestations - Other, specify
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Lung infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Rhinitis infective
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Thrush
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0053 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected8 at risk
Upper respiratory infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Infusion related reaction
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Wrist fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Activated partial thromboplastin time prolonged
Investigations
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0016 events3 affected6 at risk
EG00210 events3 affected3 at risk
EG00313 events3 affected5 at risk
EG0047 events3 affected3 at risk
EG00522 events6 affected6 at risk
EG0064 events3 affected8 at risk
EG0079 events4 affected8 at risk
Alkaline phosphatase increased
Investigations
Systematic Assessment
EG0001 events1 affected3 at risk
EG0018 events5 affected6 at risk
EG0021 events1 affected3 at risk
EG0035 events2 affected5 at risk
EG0043 events2 affected3 at risk
EG0058 events4 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0006 events3 affected3 at risk
EG00111 events5 affected6 at risk
EG00212 events3 affected3 at risk
EG00324 events5 affected5 at risk
EG00418 events3 affected3 at risk
EG00536 events6 affected6 at risk
EG0069 events3 affected8 at risk
EG00724 events8 affected8 at risk
Blood bilirubin increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0043 events2 affected3 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0073 events3 affected8 at risk
Blood lactate dehydrogenase increased
Investigations
Systematic Assessment
EG0002 events2 affected3 at risk
EG0015 events4 affected6 at risk
EG0022 events2 affected3 at risk
EG0031 events1 affected5 at risk
EG0043 events3 affected3 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Cholesterol high
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
CPK increased
Investigations
Systematic Assessment
EG00015 events3 affected3 at risk
EG00116 events5 affected6 at risk
EG00211 events3 affected3 at risk
EG00317 events5 affected5 at risk
EG0048 events3 affected3 at risk
EG00519 events6 affected6 at risk
EG0062 events1 affected8 at risk
EG0075 events3 affected8 at risk
Creatinine increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0032 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0065 events2 affected8 at risk
EG0073 events3 affected8 at risk
GGT increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
INR increased
Investigations
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Lipase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0064 events1 affected8 at risk
EG0075 events3 affected8 at risk
Platelet count decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0073 events2 affected8 at risk
Serum amylase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0072 events2 affected8 at risk
Anorexia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0042 events2 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0075 events3 affected8 at risk
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Hyperglycemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Hypoalbuminemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events3 affected6 at risk
EG0021 events1 affected3 at risk
EG0033 events1 affected5 at risk
EG0042 events1 affected3 at risk
EG0056 events2 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Hypoglycemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Hypokalemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Hypomagnesemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Hyponatremia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0075 events2 affected8 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0074 events2 affected8 at risk
Arthritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Musculoskeletal and connective tissue disorder - Other, specify
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0072 events1 affected8 at risk
Neck pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Dizziness
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Headache
Nervous system disorders
Systematic Assessment
EG0004 events2 affected3 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0063 events3 affected8 at risk
EG0072 events1 affected8 at risk
Nervous system disorders - Other, specify
Nervous system disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Paresthesia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Peripheral sensory neuropathy
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0053 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0072 events2 affected8 at risk
Anxiety
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Depression
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Insomnia
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Irritability
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Hematuria
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0032 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Proteinuria
Renal and urinary disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Urinary frequency
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected8 at risk
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0062 events2 affected8 at risk
EG0073 events3 affected8 at risk
Dyspnea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0063 events2 affected8 at risk
EG0074 events4 affected8 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Hoarseness
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected8 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Pneumonitis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Postnasal drip
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Rhinorrhea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Sleep apnea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Bullous dermatitis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Erythema multiforme
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
Periorbital edema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0015 events4 affected6 at risk
EG0021 events1 affected3 at risk
EG0033 events2 affected5 at risk
EG0041 events1 affected3 at risk
EG0052 events2 affected6 at risk
EG0061 events1 affected8 at risk
EG0072 events2 affected8 at risk
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected3 at risk
EG0032 events2 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected8 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events3 affected6 at risk
EG0023 events2 affected3 at risk
EG0032 events2 affected5 at risk
EG0042 events2 affected3 at risk
EG0053 events3 affected6 at risk
EG0061 events1 affected8 at risk
EG0072 events2 affected8 at risk
Skin and subcutaneous tissue disorders - Other, specify
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0072 events2 affected8 at risk
Flushing
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Hypertension
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0074 events3 affected8 at risk
Hypotension
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0075 events3 affected8 at risk
Thromboembolic event
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected8 at risk
Not provided
Results Disclosure Restriction on PI(s)?
Not provided
Other Details
Not provided
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D000230
Adenocarcinoma
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D007680
Kidney Neoplasms
D014571
Urologic Neoplasms
D014565
Urogenital Neoplasms
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications