Trial Outcomes & Findings for Cabozantinib for Adults With Advanced Soft Tissue Sarcoma (NCT NCT01755195)
NCT ID: NCT01755195
Last Updated: 2024-01-03
Results Overview
Objective response was assessed by the Response Evaluation Criteria in Solid Tumors RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Date treatment consent signed to date off study, approximately 86 months and 3 days.
Results posted on
2024-01-03
Participant Flow
Participant milestones
| Measure |
Cabozantinib
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Cabozantinib
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Overall Study
Participant noncompliance
|
2
|
|
Overall Study
Switched to alternative treatment
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Participant refused to start treatment
|
1
|
|
Overall Study
Participant has been consented for another trial
|
1
|
|
Overall Study
Refused further treatment
|
3
|
|
Overall Study
Complicating disease/intercurrent illness
|
1
|
Baseline Characteristics
Cabozantinib for Adults With Advanced Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Cabozantinib
n=55 Participants
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
49.69 years
STANDARD_DEVIATION 12.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 86 months and 3 days.Population: 1/55 participants did not start therapy.
Objective response was assessed by the Response Evaluation Criteria in Solid Tumors RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Cabozantinib
n=54 Participants
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Objective Response (Complete Response (CR)+Partial Response (PR) of Cabozantinib in Patients With Soft Tissue Sarcomas
|
11.1 percentage of particpants
Interval 4.2 to 22.6
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 1/55 participants did not start therapy.
Progression in participants with soft tissue sarcomas treated with cabozantinib was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
Cabozantinib
n=54 Participants
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Percentage of Participants With 6 Month Progression Free Survival (PFS)
|
49.3 percentage of participants
Interval 36.2 to 67.3
|
SECONDARY outcome
Timeframe: Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1Population: 42/54 participants were analyzed for this outcome measure. One participant did not start therapy, and twelve participants did not participate in the optional biomarker testing.
Blood samples were collected before treatment on the first day of cycles 1 and 2 to determine circulating levels of HGF. HGF protein content (in picograms; pg) in blood plasma (in milliliters; mL) was measured for each sample with a two-site immunoassay and the difference from before to after treatment for each patient was reported. A change in this biomarker from the baseline value has not been linked to clinical outcomes; that is, it is neither a good or a bad outcome.
Outcome measures
| Measure |
Cabozantinib
n=42 Participants
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Mean Change From Baseline in Levels of Circulating Hepatocyte Growth Factor (HGF)
Baseline to Cycle 1 Day 1
|
-51.3 pg/mL
Interval -235.5 to 151.0
|
|
Mean Change From Baseline in Levels of Circulating Hepatocyte Growth Factor (HGF)
Baseline to Cycle 2 Day 1
|
344.8 pg/mL
Interval 4.1 to 685.6
|
SECONDARY outcome
Timeframe: Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1Population: 42/54 participants were analyzed for this outcome measure. One participant did not start therapy, and twelve participants did not participate in the optional biomarker testing.
Blood samples were collected before treatment on the first day of cycles 1 and 2 to determine circulating levels of soluble MET (sMET). sMET protein content (in nanograms; ng) in blood plasma (in milliliters; mL) was measured for each sample with a two-site immunoassay and the difference from before to after treatment for each patient was reported. A change in this biomarker from the baseline value has not been linked to clinical outcomes; that is, it is neither a good or a bad outcome.
Outcome measures
| Measure |
Cabozantinib
n=42 Participants
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Mean Change From Baseline in Levels of Circulating Soluble Mesenchymal Epithelial Transition Factor (sMET)
Baseline to Cycle 1 Day 1
|
-6.1 ng/mL
Interval -12.0 to -0.3
|
|
Mean Change From Baseline in Levels of Circulating Soluble Mesenchymal Epithelial Transition Factor (sMET)
Baseline to Cycle 2 Day1
|
16.4 ng/mL
Interval 3.4 to 29.4
|
SECONDARY outcome
Timeframe: Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1Population: 42/54 participants were analyzed for this outcome measure. One participant did not start therapy, and twelve participants did not participate in the optional biomarker testing.
Blood samples were collected before treatment on the first day of cycles 1 and 2 to determine circulating levels of VEGF-A. VEGF-A protein content (in picograms; pg) in blood plasma (in milliliters; mL) was measured for each sample with a two-site immunoassay and the difference from before to after treatment for each patient was reported. A change in this biomarker from the baseline value has not been linked to clinical outcomes; that is, it is neither a good or a bad outcome.
Outcome measures
| Measure |
Cabozantinib
n=42 Participants
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Mean Change From Baseline in Levels of Circulating Vascular Endothelial Growth Factor A (VEGF-A)
Baseline to Cycle 2 Day 1
|
32.5 pg/mL
Interval 6.5 to 58.5
|
|
Mean Change From Baseline in Levels of Circulating Vascular Endothelial Growth Factor A (VEGF-A)
Baseline to Cycle 1 Day 1
|
5.6 pg/mL
Interval -3.6 to 14.7
|
SECONDARY outcome
Timeframe: Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1Population: 42/54 participants were analyzed for this outcome measure. One participant did not start therapy, and twelve participants did not participate in the optional biomarker testing.
Blood samples were collected before treatment on the first day of cycles 1 and 2 to determine circulating levels of soluble VEGFR2 (sVEGFR-2). sVEGFR-2 protein content (in nanograms; ng) in blood plasma (in milliliters; mL) was measured for each sample with a two-site immunoassay and the difference from before to after treatment for each patient was reported. A change in this biomarker from the baseline value has not been linked to clinical outcomes; that is, it is neither a good or a bad outcome..
Outcome measures
| Measure |
Cabozantinib
n=42 Participants
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Mean Change From Baseline in Levels of Circulating Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR-2)
Baseline to Cycle 1 Day 1
|
-1.0 ng/mL
Interval -2.6 to 0.6
|
|
Mean Change From Baseline in Levels of Circulating Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR-2)
Baseline to Cycle 2 Day 1
|
-10.9 ng/mL
Interval -13.5 to -8.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 86 months and 3 days.Population: 1/55 participants did not start therapy.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Cabozantinib
n=54 Participants
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
53 Participants
|
Adverse Events
Cabozantinib
Serious events: 14 serious events
Other events: 53 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Cabozantinib
n=54 participants at risk
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
Fatigue
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
General disorders and administration site conditions - Other, fever
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Headache
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Hematuria
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, neoplasm
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Serum amylase increased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Stroke
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Syncope
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Vascular disorders
Thromboembolic event
|
5.6%
3/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Tooth infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Transient ischemic attacks
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Upper respiratory infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
Other adverse events
| Measure |
Cabozantinib
n=54 participants at risk
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
9/54 • Number of events 25 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.1%
6/54 • Number of events 14 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Alanine aminotransferase increased
|
53.7%
29/54 • Number of events 59 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Alkaline phosphatase increased
|
40.7%
22/54 • Number of events 28 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Immune system disorders
Allergic reaction
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
6/54 • Number of events 9 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Blood and lymphatic system disorders
Anemia
|
24.1%
13/54 • Number of events 32 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
35.2%
19/54 • Number of events 30 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
46.3%
25/54 • Number of events 51 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
7/54 • Number of events 8 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Bladder perforation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Bloating
|
3.7%
2/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, Blood in stool due to hemorrhoids
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Blood bilirubin increased
|
5.6%
3/54 • Number of events 7 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Eye disorders
Blurred vision
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Brachial plexopathy
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
9/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
CPK increased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Cardiac disorders
Chest pain - cardiac
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
Chills
|
9.3%
5/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Concentration impairment
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Psychiatric disorders
Confusion
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Constipation
|
31.5%
17/54 • Number of events 24 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
8/54 • Number of events 9 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Creatinine increased
|
9.3%
5/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.0%
7/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Dental caries
|
1.9%
1/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Psychiatric disorders
Depression
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
51.9%
28/54 • Number of events 70 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Dizziness
|
22.2%
12/54 • Number of events 17 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Eye disorders
Dry eye
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Dry mouth
|
22.2%
12/54 • Number of events 19 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.8%
8/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Dysgeusia
|
31.5%
17/54 • Number of events 24 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.5%
10/54 • Number of events 11 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Dysphagia
|
11.1%
6/54 • Number of events 6 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.4%
11/54 • Number of events 15 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Ear and labyrinth disorders
Ear pain
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
Edema face
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
Edema limbs
|
13.0%
7/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Endocrine disorders
Endocrine disorders - Other, Lactate dehydrogenase increased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Enterocolitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.0%
7/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Esophageal pain
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Eye disorders
Eye disorders - Other, Eye disorders; erythrodysesthesia syndrome
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Eye disorders
Eye disorders - Other, Eye disorders; loss of peripheral vision
|
1.9%
1/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Eye disorders
Eye disorders - Other, High Spatial Frequencies
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Eye disorders
Eye disorders - Other, Vision change (black spots)
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
Fatigue
|
44.4%
24/54 • Number of events 48 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
Fever
|
11.1%
6/54 • Number of events 6 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Eye disorders
Flashing lights
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Flatulence
|
13.0%
7/54 • Number of events 9 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
Flu like symptoms
|
9.3%
5/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Vascular disorders
Flushing
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
Gait disturbance
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.4%
4/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, GI:Increased Salivation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Gastrointestinal disorders - Other, specify: Rectal discharge
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, blood in stool
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, intermittent decrease/loss of appetite
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, loose stool
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
General disorders and administration site conditions - Other, Mouth Sores
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
General disorders and administration site conditions - Other, Numbness of Tongue
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Gingival pain
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Gum infection
|
1.9%
1/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Headache
|
37.0%
20/54 • Number of events 45 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Hematuria
|
13.0%
7/54 • Number of events 9 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Hemoglobinuria
|
7.4%
4/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.9%
1/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
9/54 • Number of events 11 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hot flashes
|
9.3%
5/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
6/54 • Number of events 9 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.3%
5/54 • Number of events 9 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.7%
2/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Vascular disorders
Hypertension
|
79.6%
43/54 • Number of events 437 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Endocrine disorders
Hyperthyroidism
|
3.7%
2/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
31.5%
17/54 • Number of events 38 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.4%
4/54 • Number of events 13 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
3/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.0%
7/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
6/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.3%
5/54 • Number of events 19 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.9%
14/54 • Number of events 27 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Vascular disorders
Hypotension
|
7.4%
4/54 • Number of events 8 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Endocrine disorders
Hypothyroidism
|
35.2%
19/54 • Number of events 27 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Infections and infestations - Other, Facial infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Infections and infestations - Other, Infection - Tumor fungation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Infections and infestations - Other, Malaria
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Infections and infestations - Other, Post-dental work
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Infections and infestations - Other, Urine
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Infections and infestations - Other, Viral Infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, Urine PCR
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Psychiatric disorders
Insomnia
|
9.3%
5/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Investigations - Other, Hyperphosphatemia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Investigations - Other, Lactate dehydrogenase increased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Investigations - Other, Protein total decreased
|
5.6%
3/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Investigations - Other, Total protein decreased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Lipase increased
|
20.4%
11/54 • Number of events 24 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Lymphocyte count decreased
|
24.1%
13/54 • Number of events 46 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
Malaise
|
1.9%
1/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Memory impairment
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Early Satiety
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Mucosal infection
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.9%
14/54 • Number of events 33 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, intermittent muscle spasms
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.4%
11/54 • Number of events 16 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Nail infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.3%
5/54 • Number of events 6 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Nausea
|
44.4%
24/54 • Number of events 56 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.4%
4/54 • Number of events 9 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Neuralgia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Neutrophil count decreased
|
24.1%
13/54 • Number of events 71 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
5.6%
3/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
9/54 • Number of events 11 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
General disorders
Pain
|
18.5%
10/54 • Number of events 16 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.5%
10/54 • Number of events 14 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.7%
2/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
53.7%
29/54 • Number of events 55 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Paresthesia
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Periodontal disease
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Eye disorders
Photophobia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Platelet count decreased
|
29.6%
16/54 • Number of events 23 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Presyncope
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Proteinuria
|
24.1%
13/54 • Number of events 27 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Radiculitis
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.4%
4/54 • Number of events 6 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Rectal pain
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Dysuria
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Protein Creatinine Ratio Increased
|
1.9%
1/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Urine protein-Creatinine ratio increased
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, elevated protein/creatinine ratio
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, hesitancy
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, proteinuria
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, URI with cold
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, bronchitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Serum amylase increased
|
13.0%
7/54 • Number of events 59 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Cardiac disorders
Sinus bradycardia
|
7.4%
4/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Cardiac disorders
Sinus tachycardia
|
7.4%
4/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Sinusitis
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, B/L lower extremity lacerations;
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Cellulitis with fistula (supra-pubic area-LLQ)
|
1.9%
1/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Chest Redness
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Erythema along port
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Graft dehiscence
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Hair hypopigmentation
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Hair thinning
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Lump on upper L chest wall
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Pruritus /Rash acneiform
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Seborrheic dermatitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Skin and subcutaneous tissue disorders - Other: hair
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Skin discoloration (over R shoulder)
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Skin lumps (face, ear, hairline)
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, fingernail splitting
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, hair lightening
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, hand purple/blue discoloration
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, intermittent petechiae bilateral breast
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, pin-size hole over port (no drainage)
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, sore on elbow
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, sunburn from swimming; chest, back, BUE
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other,
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
18.5%
10/54 • Number of events 12 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Skin infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
22.2%
12/54 • Number of events 13 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Spasticity
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Stomach pain
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Nervous system disorders
Syncope
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Vascular disorders
Thromboembolic event
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Thyroid stimulating hormone increased
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Tooth development disorder
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Tooth infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Toothache
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
7.4%
4/54 • Number of events 9 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Upper respiratory infection
|
13.0%
7/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Urinary frequency
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Urinary tract infection
|
7.4%
4/54 • Number of events 6 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Urinary tract pain
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Urinary urgency
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Renal and urinary disorders
Urine discoloration
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Infections and infestations
Vaginal infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Reproductive system and breast disorders
Vaginal pain
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Ear and labyrinth disorders
Vertigo
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Gastrointestinal disorders
Vomiting
|
31.5%
17/54 • Number of events 41 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
Weight loss
|
29.6%
16/54 • Number of events 49 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
White blood cell decreased
|
35.2%
19/54 • Number of events 71 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Investigations
weight loss
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Endocrine disorders
Endocrine disorders - Other, TSH decreased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis lower limb
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Teeth extractions
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 86 months and 3 days.
1/55 participants did not start therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place