Trial Outcomes & Findings for Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF (NCT NCT00661622)
NCT ID: NCT00661622
Last Updated: 2025-05-16
Results Overview
Complete response: Disappearance of all target and non-target liver lesions Partial response: \>= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions Stable disease: Absence of change which would qualify as response or progression Progression: \>= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions \>= 10mm in the treated lobe(s)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Every 8 weeks
Results posted on
2025-05-16
Participant Flow
Participant milestones
| Measure |
Immunoembolization
Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
Plain Embolization
Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Immunoembolization
Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
Plain Embolization
Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF
Baseline characteristics by cohort
| Measure |
Immunoembolization
n=25 Participants
Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
Plain Embolization
n=27 Participants
Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=99 Participants
|
62 years
n=107 Participants
|
58 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
27 participants
n=107 Participants
|
52 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Every 8 weeksComplete response: Disappearance of all target and non-target liver lesions Partial response: \>= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions Stable disease: Absence of change which would qualify as response or progression Progression: \>= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions \>= 10mm in the treated lobe(s)
Outcome measures
| Measure |
Immunoembolization
n=26 Participants
Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
Plain Embolization
n=27 Participants
Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
|---|---|---|
|
Response of Liver Metastases
Complete response (CR)
|
0 participants
|
0 participants
|
|
Response of Liver Metastases
Partial response (PR)
|
5 participants
|
3 participants
|
|
Response of Liver Metastases
Stable disease (SD)
|
12 participants
|
19 participants
|
|
Response of Liver Metastases
Progression (PD)
|
8 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Baseline then 3 to 4 weeks after every 2 treatmentsClinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments.
Outcome measures
| Measure |
Immunoembolization
n=26 Participants
Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
Plain Embolization
n=27 Participants
Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
|---|---|---|
|
Overall Response Rate
|
21.2 percentage of participants
Interval 10.3 to 30.5
|
16.7 percentage of participants
Interval 6.3 to 26.9
|
SECONDARY outcome
Timeframe: Baseline to deathMeasured from the start of the treatment to death of patients
Outcome measures
| Measure |
Immunoembolization
n=26 Participants
Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
Plain Embolization
n=27 Participants
Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
|---|---|---|
|
Overall Survival
|
21.5 months
Interval 18.5 to 24.8
|
17.2 months
Interval 11.9 to 22.4
|
SECONDARY outcome
Timeframe: Baseline to time of progressionMeasured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions \>= 10mm in the treated lobe(s).
Outcome measures
| Measure |
Immunoembolization
n=26 Participants
Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
Plain Embolization
n=27 Participants
Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
|---|---|---|
|
Median Progression Free Survival
|
3.9 months
Interval 3.5 to 4.3
|
5.9 months
Interval 5.5 to 6.2
|
SECONDARY outcome
Timeframe: Baseline to time of progressionMeasured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions \>= 10mm in the treated lobe(s).
Outcome measures
| Measure |
Immunoembolization
n=26 Participants
Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
Plain Embolization
n=27 Participants
Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
|---|---|---|
|
Systemic Progression Free Survival
|
10.4 months
Interval 7.5 to 13.2
|
7.1 months
Interval 5.0 to 9.1
|
Adverse Events
Immunoembolization
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Plain Embolization
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immunoembolization
n=26 participants at risk
Liver embolization treatment with injection of GM-CSF.
|
Plain Embolization
n=27 participants at risk
Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
|---|---|---|
|
General disorders
Abdominal pain
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Blood and lymphatic system disorders
Aneurysms
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Death
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
7.7%
2/26 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Hepatobiliary disorders
Liver pain
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
Other adverse events
| Measure |
Immunoembolization
n=26 participants at risk
Liver embolization treatment with injection of GM-CSF.
|
Plain Embolization
n=27 participants at risk
Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
|
|---|---|---|
|
General disorders
Agitation
|
3.8%
1/26 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Anorexia
|
15.4%
4/26 • Number of events 6
|
18.5%
5/27 • Number of events 13
|
|
Psychiatric disorders
Anxiety
|
7.7%
2/26 • Number of events 2
|
11.1%
3/27 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Athritis
|
0.00%
0/26
|
7.4%
2/27 • Number of events 3
|
|
General disorders
Back pain
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Belching
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Bleeding
|
3.8%
1/26 • Number of events 2
|
11.1%
3/27 • Number of events 3
|
|
General disorders
Bleeding at procedure site
|
3.8%
1/26 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Bloating
|
3.8%
1/26 • Number of events 2
|
0.00%
0/27
|
|
Eye disorders
Blurred vision
|
3.8%
1/26 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
3.8%
1/26 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Bruising
|
7.7%
2/26 • Number of events 3
|
14.8%
4/27 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Bruising at cath site
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Burning upper quadrant pain
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Chills/rigors
|
15.4%
4/26 • Number of events 6
|
11.1%
3/27 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
3.8%
1/26 • Number of events 1
|
7.4%
2/27 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
19.2%
5/26 • Number of events 8
|
18.5%
5/27 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Blood and lymphatic system disorders
Decreased granulocytes
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Decreased hemoglobin
|
61.5%
16/26 • Number of events 96
|
63.0%
17/27 • Number of events 147
|
|
Eye disorders
Decreased visual acuity
|
0.00%
0/26
|
7.4%
2/27 • Number of events 2
|
|
Blood and lymphatic system disorders
Decreased WBC
|
7.7%
2/26 • Number of events 6
|
14.8%
4/27 • Number of events 4
|
|
General disorders
Delayed healing of insertion site
|
0.00%
0/26
|
3.7%
1/27 • Number of events 2
|
|
Psychiatric disorders
Depression
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Diaphoresis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
3/26 • Number of events 10
|
18.5%
5/27 • Number of events 8
|
|
General disorders
Disequilibrium
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Dizziness
|
11.5%
3/26 • Number of events 3
|
18.5%
5/27 • Number of events 19
|
|
General disorders
Drug allergy
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Dry mouth
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Dysgeusia
|
3.8%
1/26 • Number of events 2
|
7.4%
2/27 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.5%
3/26 • Number of events 7
|
7.4%
2/27 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Edema
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Epigastric pain
|
0.00%
0/26
|
3.7%
1/27 • Number of events 2
|
|
General disorders
Fatigue
|
42.3%
11/26 • Number of events 26
|
33.3%
9/27 • Number of events 26
|
|
General disorders
Fever
|
34.6%
9/26 • Number of events 15
|
29.6%
8/27 • Number of events 14
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
2/26 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Flu
|
3.8%
1/26 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Blood and lymphatic system disorders
Fluid overload
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Fungal nail infection
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/26
|
14.8%
4/27 • Number of events 10
|
|
General disorders
Headache
|
3.8%
1/26 • Number of events 1
|
11.1%
3/27 • Number of events 6
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/26
|
3.7%
1/27 • Number of events 2
|
|
Cardiac disorders
Heart palpitations
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.00%
0/26
|
7.4%
2/27 • Number of events 2
|
|
General disorders
Hoarseness
|
3.8%
1/26 • Number of events 2
|
0.00%
0/27
|
|
General disorders
Hot flashes
|
0.00%
0/26
|
3.7%
1/27 • Number of events 3
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Hypertension
|
3.8%
1/26 • Number of events 2
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
3.8%
1/26 • Number of events 4
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Hypotension
|
11.5%
3/26 • Number of events 6
|
7.4%
2/27 • Number of events 4
|
|
Blood and lymphatic system disorders
Increased bilirubin
|
7.7%
2/26 • Number of events 3
|
7.4%
2/27 • Number of events 2
|
|
Blood and lymphatic system disorders
Increased alkaline phosphatase
|
34.6%
9/26 • Number of events 31
|
33.3%
9/27 • Number of events 36
|
|
Blood and lymphatic system disorders
Increased creatinine
|
7.7%
2/26 • Number of events 8
|
3.7%
1/27 • Number of events 1
|
|
Blood and lymphatic system disorders
Increased SGOT
|
84.6%
22/26 • Number of events 97
|
81.5%
22/27 • Number of events 114
|
|
Blood and lymphatic system disorders
Increased SGPT
|
84.6%
22/26 • Number of events 109
|
81.5%
22/27 • Number of events 117
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Insomnia
|
3.8%
1/26 • Number of events 2
|
14.8%
4/27 • Number of events 4
|
|
General disorders
Irritation
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Joint pain
|
0.00%
0/26
|
7.4%
2/27 • Number of events 2
|
|
General disorders
Lethargy
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.8%
8/26 • Number of events 32
|
37.0%
10/27 • Number of events 26
|
|
Blood and lymphatic system disorders
Lymphpenia
|
3.8%
1/26 • Number of events 8
|
7.4%
2/27 • Number of events 2
|
|
General disorders
Muscle cramp
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Muscle pain
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Nausea
|
65.4%
17/26 • Number of events 63
|
48.1%
13/27 • Number of events 27
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
1/26 • Number of events 2
|
0.00%
0/27
|
|
General disorders
Night sweats
|
7.7%
2/26 • Number of events 2
|
3.7%
1/27 • Number of events 2
|
|
General disorders
Nose bleed
|
0.00%
0/26
|
7.4%
2/27 • Number of events 3
|
|
General disorders
Orthostatic hypotension
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Pain
|
80.8%
21/26 • Number of events 84
|
81.5%
22/27 • Number of events 98
|
|
Psychiatric disorders
Personality change
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
4/26 • Number of events 11
|
11.1%
3/27 • Number of events 6
|
|
General disorders
Sensitivity to heat
|
3.8%
1/26 • Number of events 1
|
3.7%
1/27 • Number of events 2
|
|
General disorders
Sinus allergies
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Sinus pain
|
3.8%
1/26 • Number of events 2
|
0.00%
0/27
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Slurred speech
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Sprained ankle
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Stiff neck
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Sweating
|
0.00%
0/26
|
7.4%
2/27 • Number of events 4
|
|
General disorders
Swollen knee
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Tachycardia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.1%
6/26 • Number of events 44
|
18.5%
5/27 • Number of events 13
|
|
General disorders
Upper respiratory infection
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
26.9%
7/26 • Number of events 22
|
22.2%
6/27 • Number of events 9
|
|
General disorders
Weakness
|
0.00%
0/26
|
14.8%
4/27 • Number of events 5
|
|
General disorders
Weight loss
|
0.00%
0/26
|
7.4%
2/27 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place