Trial Outcomes & Findings for Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors (NCT NCT00108069)
NCT ID: NCT00108069
Last Updated: 2015-11-05
Results Overview
Complete response (CR) is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. All measurable, evaluable and non-evaluable lesions and site must be assessed using the same techniques as baseline. Patients who respond must be on the same or decreasing doses of dexamethasone. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using same techniques as baseline. Responders must be on the same decreasing doses of dexamethasone. Stable disease (SD) does not qualify for CR, PR, or progression (e.g., a 25% increase in the sum of products of all measurable lesions). The designation of stable/no response requires a minimum of 6 weeks duration. All measurable and evaluable sites must be assessed using the same techniques as baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Patients were followed for an average of six weeks for assessment of response
Results posted on
2015-11-05
Participant Flow
Participant milestones
| Measure |
GBM (Glioblastoma Multiforme)
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
AG (Anaplastic Glioma)
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
13
|
Reasons for withdrawal
| Measure |
GBM (Glioblastoma Multiforme)
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
AG (Anaplastic Glioma)
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
|---|---|---|
|
Overall Study
Never rec'd study drug
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Progessive disease
|
27
|
11
|
Baseline Characteristics
Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors
Baseline characteristics by cohort
| Measure |
GBM (Glioblastoma Multiforme)
n=30 Participants
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
AG (Anaplastic Glioma)
n=12 Participants
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 12 • n=93 Participants
|
42 years
STANDARD_DEVIATION 10 • n=4 Participants
|
44 years
STANDARD_DEVIATION 11 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
12 participants
n=4 Participants
|
42 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Patients were followed for an average of six weeks for assessment of responsePopulation: Two patients were not able to complete follow-up neuroimaging to assess response due to clinical progression of disease.
Complete response (CR) is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. All measurable, evaluable and non-evaluable lesions and site must be assessed using the same techniques as baseline. Patients who respond must be on the same or decreasing doses of dexamethasone. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using same techniques as baseline. Responders must be on the same decreasing doses of dexamethasone. Stable disease (SD) does not qualify for CR, PR, or progression (e.g., a 25% increase in the sum of products of all measurable lesions). The designation of stable/no response requires a minimum of 6 weeks duration. All measurable and evaluable sites must be assessed using the same techniques as baseline.
Outcome measures
| Measure |
GBM (Glioblastoma Multiforme)
n=28 Participants
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
AG (Anaplastic Glioma)
n=12 Participants
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
Grade 3
Severe adverse event
|
Grade 4
Life-threatening or disabling adverse event
|
Grade 5
Death related to adverse event
|
Total
Total number of participants.
|
|---|---|---|---|---|---|---|
|
Response, Defined as Stable Disease or Objective (Partial or Complete) Response.
Complete response
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Response, Defined as Stable Disease or Objective (Partial or Complete) Response.
Partial response
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Response, Defined as Stable Disease or Objective (Partial or Complete) Response.
Stable disease
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Response, Defined as Stable Disease or Objective (Partial or Complete) Response.
Progressive disease
|
27 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7.5 yearsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
GBM (Glioblastoma Multiforme)
n=30 Participants
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
AG (Anaplastic Glioma)
n=12 Participants
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
Grade 3
Severe adverse event
|
Grade 4
Life-threatening or disabling adverse event
|
Grade 5
Death related to adverse event
|
Total
Total number of participants.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
30 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7.5 yearsPopulation: Neither cohort completed planned accrual and are small in number separately. Additionally, the underlying histological grade would not affect toxicity. Therefore, these cohorts may be combined. The Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs.
The combined serious and non-serious adverse event Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs for the GBM (Glioblastoma multiforme) and AG (Anaplastic glioma) cohorts.
Outcome measures
| Measure |
GBM (Glioblastoma Multiforme)
n=42 Participants
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
AG (Anaplastic Glioma)
n=42 Participants
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
Grade 3
n=42 Participants
Severe adverse event
|
Grade 4
n=42 Participants
Life-threatening or disabling adverse event
|
Grade 5
n=42 Participants
Death related to adverse event
|
Total
n=42 Participants
Total number of participants.
|
|---|---|---|---|---|---|---|
|
Adverse Event Grades
thrombocytopenia
|
19 participants
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
24 participants
|
|
Adverse Event Grades
lymphopenia
|
4 participants
|
4 participants
|
4 participants
|
0 participants
|
0 participants
|
12 participants
|
|
Adverse Event Grades
hypophosphatemia
|
0 participants
|
6 participants
|
3 participants
|
0 participants
|
0 participants
|
9 participants
|
|
Adverse Event Grades
ALT/sGPT
|
6 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
7 participants
|
|
Adverse Event Grades
anemia (Decreased Hgb)
|
6 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
6 participants
|
|
Adverse Event Grades
hyponatremia
|
4 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
5 participants
|
|
Adverse Event Grades
headache
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Adverse Event Grades
leukopenia
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Adverse Event Grades
AST/sGOT
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Adverse Event Grades
dyspnea
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Adverse Event Grades
fatigue
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Adverse Event Grades
fever
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Adverse Event Grades
hyperkalemia
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Adverse Event Grades
cough
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
depression (mood alteration)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
diarrhea
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
dizziness
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
venous thrombosis
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
edema
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
hyperbilirubinemia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
hypermagnesemia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
hypocalcemia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
hypokalemia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
hypotension
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
elevated creatinine
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
infection with unknown ANC
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
neutropenia
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
pain
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
rash
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
hemorrhage (rectal)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
somnolence
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Event Grades
urinary frequency
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
GBM (Glioblastoma Multiforme)
Serious events: 11 serious events
Other events: 26 other events
Deaths: 0 deaths
AG (Anaplastic Glioma)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GBM (Glioblastoma Multiforme)
n=30 participants at risk
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
AG (Anaplastic Glioma)
n=12 participants at risk
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
|---|---|---|
|
General disorders
Death not associated with CTCAE term: Death NOS
|
3.3%
1/30 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term: Disease progression NOS
|
13.3%
4/30 • Number of events 4
|
0.00%
0/12
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Infection - Other (Specify, infection w/unknown ANC)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Platelets
|
3.3%
1/30 • Number of events 2
|
0.00%
0/12
|
|
Nervous system disorders
Neuropathy: motor
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Pain: head/headache
|
6.7%
2/30 • Number of events 2
|
0.00%
0/12
|
|
Nervous system disorders
Seizure
|
13.3%
4/30 • Number of events 4
|
8.3%
1/12 • Number of events 2
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
3.3%
1/30 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Speech impairment (e.g., dysphagia or aphasia)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Vascular disorders
Vascular - Other (Specify-deep vein thrombosis)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC<1.0 x 10e9/L)
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, genralized or specific area (not due to neuropathy): Right-sided
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
Other adverse events
| Measure |
GBM (Glioblastoma Multiforme)
n=30 participants at risk
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
AG (Anaplastic Glioma)
n=12 participants at risk
Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day
|
|---|---|---|
|
General disorders
Death not associated with CTCAE term: Disease progression NOS
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
23.3%
7/30 • Number of events 7
|
25.0%
3/12 • Number of events 3
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
13.3%
4/30 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Ataxia
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, elevated white blood count;)
|
6.7%
2/30 • Number of events 2
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
6.7%
2/30 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Nervous system disorders
Cognitive disturbance
|
6.7%
2/30 • Number of events 2
|
0.00%
0/12
|
|
Nervous system disorders
Confusion
|
3.3%
1/30 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.3%
1/30 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema: limb
|
6.7%
2/30 • Number of events 2
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Extremity - lower (gait-walking)
|
3.3%
1/30 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
13.3%
4/30 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC<1.0 x 10e9/L)
|
3.3%
1/30 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
13.3%
4/30 • Number of events 6
|
0.00%
0/12
|
|
Cardiac disorders
Hypotension
|
3.3%
1/30 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
6.7%
2/30 • Number of events 3
|
16.7%
2/12 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
10/30 • Number of events 14
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
3.3%
1/30 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Mood alteration: depression
|
6.7%
2/30 • Number of events 2
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Facial
|
6.7%
2/30 • Number of events 2
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided
|
23.3%
7/30 • Number of events 7
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Right-sided
|
6.7%
2/30 • Number of events 2
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Whole-body/generalized
|
3.3%
1/30 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Neuropathy: motor
|
10.0%
3/30 • Number of events 5
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Neuropathy: sensory
|
3.3%
1/30 • Number of events 2
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Eye disorders
Nystagmus
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Eye disorders
Ocular/Visual - Other (Specify, horizontal diplopia)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Pain - Other (Specify, L side - hip and rib)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
3.3%
1/30 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Pain: head/headache
|
10.0%
3/30 • Number of events 4
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
20.0%
6/30 • Number of events 6
|
25.0%
3/12 • Number of events 4
|
|
Blood and lymphatic system disorders
Platelets
|
43.3%
13/30 • Number of events 21
|
33.3%
4/12 • Number of events 5
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Seizure
|
13.3%
4/30 • Number of events 5
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
13.3%
4/30 • Number of events 5
|
0.00%
0/12
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
3.3%
1/30 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Speech impairment (e.g., dysphagia or aphasia)
|
23.3%
7/30 • Number of events 7
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Vision-flashing lights/floaters
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Weight gain
|
3.3%
1/30 • Number of events 1
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Constitutional symptoms - Other (Specify, fatigue)
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage: GI: Rectum
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/30
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place