Trial Outcomes & Findings for Cabozantinib and Pembrolizumab in Metastatic Pancreas (NCT NCT05052723)
NCT ID: NCT05052723
Last Updated: 2025-11-19
Results Overview
Progress-free survival in participants, defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever comes first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
1 year
Results posted on
2025-11-19
Participant Flow
Participant milestones
| Measure |
Cabozantinib and pembrolizumab
Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Cabozantinib and pembrolizumab
Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
|
|---|---|
|
Overall Study
Death
|
19
|
Baseline Characteristics
Cabozantinib and Pembrolizumab in Metastatic Pancreas
Baseline characteristics by cohort
| Measure |
Cabozantinib and Pembrolizumab
n=21 Participants
Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
|
|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 7.19
|
|
Sex: Female, Male
Female
|
11 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
|
|
Region of Enrollment
United States
|
21 participants
|
PRIMARY outcome
Timeframe: 1 yearProgress-free survival in participants, defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever comes first.
Outcome measures
| Measure |
Cabozantinib and pembrolizumab
n=21 Participants
Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
|
|---|---|
|
Progression-free Survival
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Number of participants with complete or partial response reported
The proportion of participants with overall response to therapy via imaging; Overall Response Rate (%) = (Number of patients achieving Complete responses + Number of patients achieving partial responses / Total Number of patients) × 100
Outcome measures
| Measure |
Cabozantinib and pembrolizumab
n=21 Participants
Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
|
|---|---|
|
Number of Participants With Response to Therapy
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe proportion of participants with a complete response to therapy
Outcome measures
| Measure |
Cabozantinib and pembrolizumab
n=21 Participants
Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
|
|---|---|
|
Number of Participants With Complete Response
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe proportion of participants with a partial response to therapy
Outcome measures
| Measure |
Cabozantinib and pembrolizumab
n=21 Participants
Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
|
|---|---|
|
Number of Participants With Partial Response
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearOverall survival rate participants
Outcome measures
| Measure |
Cabozantinib and pembrolizumab
n=21 Participants
Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
|
|---|---|
|
Overall Participant Survival Rate
|
2 Participants
|
Adverse Events
Cabozantinib and pembrolizumab
Serious events: 13 serious events
Other events: 20 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Cabozantinib and pembrolizumab
n=21 participants at risk
Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Cardiac disorders
Chest pain
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Cardiac disorders
Sinus Tachycardia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Endocrine disorders
Hypothyroidism
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.8%
1/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Nausea
|
14.3%
3/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Disease Progression
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Endocarditis Infective
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Other
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Sepsis
|
9.5%
2/21 • Number of events 4 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Upper Respiratory Infection
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Urinary Tract Infection
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
3/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Blood bilirubin increased
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Creatinine increased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
INR increased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Lymphocyte count decreased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Neutrophil count decreased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Platelet count decreased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Weight loss
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
White blood cell decreased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
2/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Depressed level of consciousness
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Encephalopathy
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Stroke
|
9.5%
2/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
3/21 • Number of events 4 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Dysuria
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Proteinuria
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Renal calculi
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Hot flashes
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Thromboembolic event
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
Other adverse events
| Measure |
Cabozantinib and pembrolizumab
n=21 participants at risk
Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
|
|---|---|
|
Gastrointestinal disorders
Other
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
3/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Nausea
|
52.4%
11/21 • Number of events 15 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
7/21 • Number of events 8 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Edema face
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Edema limbs
|
23.8%
5/21 • Number of events 6 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Fatigue
|
66.7%
14/21 • Number of events 21 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Fever
|
9.5%
2/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Flu like symptoms
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Gait disturbance
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Creatinine increased
|
9.5%
2/21 • Number of events 5 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Non-cardiac chest pain
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Pain
|
19.0%
4/21 • Number of events 4 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Immune system disorders
Cytokine release syndrome
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Other
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Infective myositis
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Skin infection
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Upper respiratory infection
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Urinary tract infection
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Injury, poisoning and procedural complications
Bruising
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
9/21 • Number of events 16 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Alkaline phosphatase increased
|
23.8%
5/21 • Number of events 5 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Aspartate aminotransferase increased
|
47.6%
10/21 • Number of events 16 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Blood bilirubin increased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Cardiac troponin I increased
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Cardiac troponin T increased
|
4.8%
1/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
6/21 • Number of events 10 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Cardiac disorders
Aortic valve disease
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Cardiac disorders
Chest pain - cardiac
|
4.8%
1/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Cardiac disorders
Mitral valve disease
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Endocrine disorders
Hyperthyroidism
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Endocrine disorders
Hypothyroidism
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
6/21 • Number of events 6 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Ascites
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Bloating
|
14.3%
3/21 • Number of events 4 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Colitis
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Constipation
|
28.6%
6/21 • Number of events 7 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Diarrhea
|
52.4%
11/21 • Number of events 18 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
INR increased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Lymphocyte count decreased
|
28.6%
6/21 • Number of events 9 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Neutrophil count decreased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Platelet count decreased
|
28.6%
6/21 • Number of events 7 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Thyroid stimulating hormone increased
|
14.3%
3/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Urine output decreased
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Weight loss
|
14.3%
3/21 • Number of events 6 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
White blood cell decreased
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Metabolism and nutrition disorders
|
66.7%
14/21 • Number of events 83 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Alkalosis
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Anorexia
|
47.6%
10/21 • Number of events 11 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Dehydration
|
14.3%
3/21 • Number of events 4 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hyperglycemia
|
23.8%
5/21 • Number of events 10 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hyperkalemia
|
14.3%
3/21 • Number of events 9 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hypermagnesemia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hypernatremia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hypoalbuminemia
|
38.1%
8/21 • Number of events 9 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hypocalcemia
|
52.4%
11/21 • Number of events 18 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hypokalemia
|
19.0%
4/21 • Number of events 4 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hypomagnesemia
|
14.3%
3/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hyponatremia
|
33.3%
7/21 • Number of events 11 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hypophosphatemia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.0%
4/21 • Number of events 5 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
14.3%
3/21 • Number of events 7 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Other
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.8%
1/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Ataxia
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Dizziness
|
23.8%
5/21 • Number of events 8 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Dysarthria
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Dysgeusia
|
19.0%
4/21 • Number of events 4 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Facial muscle weakness
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Number of events 4 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Lethargy
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Muscle weakness right-sided
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Presyncope
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Psychiatric disorders
|
23.8%
5/21 • Number of events 5 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Anxiety
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Confusion
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Insomnia
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Chronic kidney disease
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Glucosuria
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Hematuria
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Proteinuria
|
19.0%
4/21 • Number of events 4 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
3/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
9.5%
2/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.5%
2/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
1/21 • Number of events 2 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Other
|
4.8%
1/21 • Number of events 3 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Hematoma
|
4.8%
1/21 • Number of events 1 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Hypertension
|
38.1%
8/21 • Number of events 13 • 1 year
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place