Trial Outcomes & Findings for Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis (NCT NCT00679367)
NCT ID: NCT00679367
Last Updated: 2017-02-20
Results Overview
Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
one year
Results posted on
2017-02-20
Participant Flow
Participant milestones
| Measure |
Melphalan Revlimid and Dexamethasone
Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Melphalan Revlimid and Dexamethasone
Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
inability to swallow oral drugs
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Baseline characteristics by cohort
| Measure |
Melphalan Revlimid and Dexamethasone
n=16 Participants
Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Gender
Female
|
10 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: Participants who completed at least 3 cycles of treatment
Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more.
Outcome measures
| Measure |
Melphalan Revlimid and Dexamethasone
n=14 Participants
Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4
|
|---|---|
|
Number of Participants With Hematologic Response
|
7 participants
|
SECONDARY outcome
Timeframe: one yearRenal response - \> 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency. Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline. Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness \> 11 mm or a decrease in New York Heart Association heart failure class. Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus. Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid. Peripheral nervous system response - resolution of clinical signs of peripheral neuropathy.
Outcome measures
| Measure |
Melphalan Revlimid and Dexamethasone
n=24 involved organs
Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4
|
|---|---|
|
Number of Organs Improved or Stable Based on Description Below:
|
10 number of organs stable or improved
|
SECONDARY outcome
Timeframe: One yearPopulation: All patients who have had at least one dose of drug.
Number of study participants removed from study treatment due to toxicities
Outcome measures
| Measure |
Melphalan Revlimid and Dexamethasone
n=16 Participants
Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4
|
|---|---|
|
Number of Participants Removed From Study Due to Toxicities
|
6 Participants
|
Adverse Events
Melphalan Revlimid and Dexamethasone
Serious events: 16 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Melphalan Revlimid and Dexamethasone
n=16 participants at risk
Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4
|
|---|---|
|
Blood and lymphatic system disorders
thromboembolism
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Renal and urinary disorders
renal failure
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Cardiac disorders
heart failure
|
25.0%
4/16 • Number of events 4 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Infections and infestations
infection
|
25.0%
4/16 • Number of events 4 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
General disorders
fatigue
|
31.2%
5/16 • Number of events 5 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
neutropenia
|
37.5%
6/16 • Number of events 6 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
leukopenia
|
31.2%
5/16 • Number of events 5 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
25.0%
4/16 • Number of events 4 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
anemia
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion - bilateral
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
Elevated blood urea nitrogen test
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Cardiac disorders
chest pressure
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
37.5%
6/16 • Number of events 6 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
gout pain
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Infections and infestations
pneumonia
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Infections and infestations
sepsis
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
dehydration
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Infections and infestations
septic shock
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Eye disorders
tear duct obstruction/infection
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
increased creatinine
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
gastrointestinal bleed
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Cardiac disorders
hypotension
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
rash
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hyponatremia
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hyperglycemia
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
pancytopenia
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
Other adverse events
| Measure |
Melphalan Revlimid and Dexamethasone
n=16 participants at risk
Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4
|
|---|---|
|
Gastrointestinal disorders
abdominal bloating
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
abdominal cramping
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
altered taste
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
anemia
|
68.8%
11/16 • Number of events 24 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
anorexia
|
25.0%
4/16 • Number of events 4 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Psychiatric disorders
anxiety
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
aspiration
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Cardiac disorders
atrial fibrillation
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Eye disorders
blurring
|
25.0%
4/16 • Number of events 4 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Cardiac disorders
bradycardia
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
General disorders
chills
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
General disorders
cold intolerance
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Psychiatric disorders
confusion
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Cardiac disorders
congestive heart failure
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
constipation
|
56.2%
9/16 • Number of events 10 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
25.0%
4/16 • Number of events 4 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
decreased bilirubin
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
decreased iron
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
General disorders
decreased performance status
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Renal and urinary disorders
decreased renal function
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Psychiatric disorders
depression
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
diarrhea
|
31.2%
5/16 • Number of events 5 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Nervous system disorders
dizziness
|
37.5%
6/16 • Number of events 6 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
dry mouth
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
dysphagia
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
75.0%
12/16 • Number of events 12 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Renal and urinary disorders
dysuria
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
early satiety
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
bruising
|
31.2%
5/16 • Number of events 5 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
edema
|
68.8%
11/16 • Number of events 13 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
General disorders
fatigue
|
81.2%
13/16 • Number of events 14 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
General disorders
fever
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
flatus
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
gout
|
18.8%
3/16 • Number of events 7 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Nervous system disorders
headache
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Ear and labyrinth disorders
hearing loss
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Eye disorders
double vision
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
hemorrhoida
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
hip fracture
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
31.2%
5/16 • Number of events 5 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hyperglycemia
|
43.8%
7/16 • Number of events 9 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hyperkalemia
|
18.8%
3/16 • Number of events 5 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hypermagnesemia
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hypernatremia
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hyperphosphatemia
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Endocrine disorders
hyperthyroidism
|
12.5%
2/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hyperuricemia
|
31.2%
5/16 • Number of events 5 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hypoalbuminemia
|
37.5%
6/16 • Number of events 7 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hypocalcemia
|
37.5%
6/16 • Number of events 6 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hypokalemia
|
31.2%
5/16 • Number of events 5 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hypomagnesemia
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hyponatremia
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
hypotension
|
12.5%
2/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
increased alkaline phosphatate
|
18.8%
3/16 • Number of events 4 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Investigations
increased Brain natriuretic peptide
|
50.0%
8/16 • Number of events 8 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Renal and urinary disorders
increased creatinine
|
37.5%
6/16 • Number of events 7 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
General disorders
insomnia
|
31.2%
5/16 • Number of events 5 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Eye disorders
itchy eyes
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
leukocytosis
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
leukopenia
|
68.8%
11/16 • Number of events 13 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Psychiatric disorders
mental disturbance
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
mouth sores
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
hemorrhage
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
muscle cramping
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
nausea
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Nervous system disorders
peripheral neuropathy
|
43.8%
7/16 • Number of events 9 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
General disorders
nocturia
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
neutropenia
|
18.8%
3/16 • Number of events 4 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Cardiac disorders
palpitations
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
pancytopenia
|
12.5%
2/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
polydipsia
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
rash
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Nervous system disorders
sciatica
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
stiffness
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
General disorders
sweats
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
56.2%
9/16 • Number of events 9 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Ear and labyrinth disorders
tinnitus
|
25.0%
4/16 • Number of events 4 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Infections and infestations
infection
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Nervous system disorders
tremors
|
12.5%
2/16 • Number of events 2 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Nervous system disorders
unsteady gait
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Infections and infestations
infection - upper respiratory
|
12.5%
2/16 • Number of events 5 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Renal and urinary disorders
urinary frequency
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Infections and infestations
infection - urinary tract
|
12.5%
2/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
vomiting
|
6.2%
1/16 • Number of events 1 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Nervous system disorders
weakness
|
37.5%
6/16 • Number of events 6 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
|
Gastrointestinal disorders
weight loss
|
18.8%
3/16 • Number of events 3 • 1 year
Toxicity data was collected throughout study participation through 30 days after last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place