Trial Outcomes & Findings for Muscadine Plus (MPX) In Men With Prostate Cancer (NCT NCT03535675)
NCT ID: NCT03535675
Last Updated: 2023-05-22
Results Overview
To determine if men who display the Alanine/Alanine superoxide dismutase 2 (SOD2) genotype of MnSOD and supplement their diet with MPX have greater changes in PSA slope following treatment compared to men that do not supplement with MPX. PSA response will be measured as the change of serum PSA in ng/mL/month, on-study PSA slope for each patient with comparisons between treatment arms adjusted for pre-study PSA slope; on-study PSA slope was calculated from PSA values taken at baseline,12, 24, 36, and 48 weeks, and calculated as the slope of the simple linear regression of the natural log of PSA versus time in ng/mL/month.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
59 participants
Primary outcome timeframe
baseline,12, 24, 36, and 48 weeks
Results posted on
2023-05-22
Participant Flow
Participant milestones
| Measure |
Muscadine Plus
Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Muscadine Plus: Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
|
Placebo
Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Placebos: The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Muscadine Plus (MPX) In Men With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Muscadine Plus
n=29 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Muscadine Plus: Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
|
Placebo
n=30 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Placebos: The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75 years
n=5 Participants
|
73 years
n=7 Participants
|
74 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Pre-study PSA slope
|
0.11 ng/mL/Month
n=5 Participants
|
0.1 ng/mL/Month
n=7 Participants
|
0.1 ng/mL/Month
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline,12, 24, 36, and 48 weeksTo determine if men who display the Alanine/Alanine superoxide dismutase 2 (SOD2) genotype of MnSOD and supplement their diet with MPX have greater changes in PSA slope following treatment compared to men that do not supplement with MPX. PSA response will be measured as the change of serum PSA in ng/mL/month, on-study PSA slope for each patient with comparisons between treatment arms adjusted for pre-study PSA slope; on-study PSA slope was calculated from PSA values taken at baseline,12, 24, 36, and 48 weeks, and calculated as the slope of the simple linear regression of the natural log of PSA versus time in ng/mL/month.
Outcome measures
| Measure |
Muscadine Plus
n=29 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Muscadine Plus: Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
|
Placebo
n=30 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Placebos: The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.
|
|---|---|---|
|
Prostate Specific Antigen (PSA) Response
|
0.106 ng/mL/Month
Interval 0.08 to 0.13
|
0.089 ng/mL/Month
Interval 0.06 to 0.11
|
SECONDARY outcome
Timeframe: Up to 26 monthsPSA doubling time (PSADT) will be calculated in months by measuring the PSA values within 12 months from start of intervention.
Outcome measures
| Measure |
Muscadine Plus
n=29 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Muscadine Plus: Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
|
Placebo
n=30 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Placebos: The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.
|
|---|---|---|
|
PSA Doubling Time
|
6.56 months
Interval 2.39 to 20.82
|
6.87 months
Interval 1.57 to 25.48
|
SECONDARY outcome
Timeframe: Up to 1 yearThe number of patients with a decrease in PSA of ≥50%
Outcome measures
| Measure |
Muscadine Plus
n=29 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Muscadine Plus: Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
|
Placebo
n=30 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Placebos: The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.
|
|---|---|---|
|
PSA Objective Response Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsThe time to disease progression for both treatment groups by PSA progression. PSA progression is defined as an increase in PSA greater than 50% and \>5 ng/ml above nadir.
Outcome measures
| Measure |
Muscadine Plus
n=29 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Muscadine Plus: Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
|
Placebo
n=30 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Placebos: The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.
|
|---|---|---|
|
PSA Progression
|
NA months
The median had not been reached in the MPX arm at the time of the analysis.
|
13.77 months
Interval 11.24 to
The upper limit of confidence interval was not reached.at the time of analysis.
|
SECONDARY outcome
Timeframe: 2 yearsThe time to disease progression for both treatment groups by radiologic disease progression (i.e. development of metastatic disease).
Outcome measures
| Measure |
Muscadine Plus
n=29 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Muscadine Plus: Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
|
Placebo
n=30 Participants
Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Placebos: The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.
|
|---|---|---|
|
Radiographic Progression
|
NA months
There were only two events, so Radiographic progression-free survival (rPFS) could not be calculated.
|
NA months
There were only two events, so Radiographic progression-free survival (rPFS) could not be calculated.
|
Adverse Events
Muscadine Plus
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Muscadine Plus
n=29 participants at risk
Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Muscadine Plus: Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
|
Placebo
n=30 participants at risk
Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Placebos: The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.
|
|---|---|---|
|
Gastrointestinal disorders
Small bowel obstruction
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
General disorders
Fatigue
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/29 • up to 2 years
|
6.7%
2/30 • Number of events 3 • up to 2 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
Other adverse events
| Measure |
Muscadine Plus
n=29 participants at risk
Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Muscadine Plus: Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
|
Placebo
n=30 participants at risk
Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Placebos: The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.
|
|---|---|---|
|
Gastrointestinal disorders
flatulence
|
3.4%
1/29 • Number of events 3 • up to 2 years
|
3.3%
1/30 • Number of events 3 • up to 2 years
|
|
Gastrointestinal disorders
constipation
|
3.4%
1/29 • Number of events 2 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Gastrointestinal disorders
diarrhea
|
3.4%
1/29 • Number of events 2 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Gastrointestinal disorders
dyspepsia
|
3.4%
1/29 • Number of events 2 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Gastrointestinal disorders
abdominal pain
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Gastrointestinal disorders
dry mouth
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Gastrointestinal disorders
nausea
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Gastrointestinal disorders
rectal hemorrhage
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
General disorders
fatigue
|
6.9%
2/29 • Number of events 4 • up to 2 years
|
6.7%
2/30 • Number of events 4 • up to 2 years
|
|
General disorders
pain
|
3.4%
1/29 • Number of events 2 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
General disorders
edema limbs
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
General disorders
non-cardiac chest pain
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
General disorders
localized edema
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Renal and urinary disorders
dysuria
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
3.3%
1/30 • Number of events 3 • up to 2 years
|
|
Renal and urinary disorders
hematuria
|
3.4%
1/29 • Number of events 2 • up to 2 years
|
3.3%
1/30 • Number of events 2 • up to 2 years
|
|
Renal and urinary disorders
urinary frequency
|
3.4%
1/29 • Number of events 2 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Renal and urinary disorders
urinary incontinence
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Renal and urinary disorders
urinary urgency
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Renal and urinary disorders
urine discoloration
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Infections and infestations
upper respiratory infection
|
3.4%
1/29 • Number of events 2 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Infections and infestations
urinary tract infection
|
3.4%
1/29 • Number of events 2 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Infections and infestations
herpes simplex reactivation
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Infections and infestations
shingles
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
postnasal drip
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
3.4%
1/29 • Number of events 3 • up to 2 years
|
3.3%
1/30 • Number of events 2 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 2 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Nervous system disorders
dizziness
|
0.00%
0/29 • up to 2 years
|
6.7%
2/30 • Number of events 2 • up to 2 years
|
|
Nervous system disorders
headache
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
3.3%
1/30 • Number of events 2 • up to 2 years
|
|
Nervous system disorders
peripheral motor neuropathy
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Nervous system disorders
spasticity
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Investigations
creatinine increased
|
3.4%
1/29 • Number of events 2 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Investigations
white blood cell decreased
|
0.00%
0/29 • up to 2 years
|
6.7%
2/30 • Number of events 2 • up to 2 years
|
|
Investigations
aspartate aminotransferase increased
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Investigations
lymphocyte count decreased
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Cardiac disorders
chest pain - cardiac
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Cardiac disorders
sinus bradycardia
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/29 • up to 2 years
|
6.7%
2/30 • Number of events 2 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
eczema
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
nail changes
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Metabolism and nutrition disorders
hypercalcemia
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Ear and labyrinth disorders
tinnitus
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Immune system disorders
allergic reaction
|
3.4%
1/29 • Number of events 1 • up to 2 years
|
0.00%
0/30 • up to 2 years
|
|
Hepatobiliary disorders
portal vein thrombosis
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
|
Vascular disorders
hot flashes
|
0.00%
0/29 • up to 2 years
|
3.3%
1/30 • Number of events 1 • up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place