Trial Outcomes & Findings for Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma (NCT NCT00802880)
NCT ID: NCT00802880
Last Updated: 2017-02-13
Results Overview
* Complete response (CR): disappearance of all target lesions, disappearance of all non-target lesions, normalization of tumor level marker * Partial response (PR): at least 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal * Stable disease (SD): neither sufficient shrinkage in target lesions to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits of normal * Progressive disease (PD): at least 20% increase in the sum of the LD of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
COMPLETED
PHASE2
80 participants
After completion of 3 cycles
2017-02-13
Participant Flow
The study opened to accrual on 03/16/2009 and closed to accrual on 12/15/2014.
Participant milestones
| Measure |
Dacarbazine
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma
Baseline characteristics by cohort
| Measure |
Dacarbazine
n=80 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
|---|---|
|
Age, Continuous
|
53 years
n=39 Participants
|
|
Gender
Female
|
40 Participants
n=39 Participants
|
|
Gender
Male
|
40 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: After completion of 3 cyclesPopulation: 3 patients failed to complete 3 cycles of treatment due to toxicity. 22 patients failed to complete 3 cycles of treatment due to progressive disease. 1 patient only had PET scan.
* Complete response (CR): disappearance of all target lesions, disappearance of all non-target lesions, normalization of tumor level marker * Partial response (PR): at least 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal * Stable disease (SD): neither sufficient shrinkage in target lesions to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits of normal * Progressive disease (PD): at least 20% increase in the sum of the LD of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Outcome measures
| Measure |
Dacarbazine
n=54 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Best Anatomical Tumor Response
Complete response
|
0 participants
|
—
|
—
|
—
|
|
Best Anatomical Tumor Response
Partial response
|
2 participants
|
—
|
—
|
—
|
|
Best Anatomical Tumor Response
Stable disease
|
22 participants
|
—
|
—
|
—
|
|
Best Anatomical Tumor Response
Progressive disease
|
30 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Completion of 6 cycles of treatment (18 weeks)* Grade 3 neutropenia = absolute neutrophil count of \<1000 - 500/mm\^3 * Grade 4 neutropenia = absolute neutrophil count of \<500/mm\^3
Outcome measures
| Measure |
Dacarbazine
n=80 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Rate of Neutropenia (Grade 3/4)
|
7.5 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Completion of 6 cycles of treatment (18 weeks)Approximately 18 weeks
Outcome measures
| Measure |
Dacarbazine
n=80 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Rate of Nausea/Emesis (Any Grade)
|
22.5 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and after every three cycles of treatment (up to 1 year)Population: The lower confidence limit is 85% and the upper confidence limit is 95%. 51 patients evaluable at baseline, 50 patients evaluable at end of cycle 3, 20 patients evaluable at end of cycle 6, 7 patients evaluable at end of cycle 9, and 5 patients evaluable at end of cycle 12.
Outcome measures
| Measure |
Dacarbazine
n=51 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Comparison of the SUV at up to 3 Tumor Sites
Baseline
|
7.42 standard uptake value
Interval 6.2 to 8.83
|
—
|
—
|
—
|
|
Comparison of the SUV at up to 3 Tumor Sites
End of cycle 3
|
7.57 standard uptake value
Interval 6.34 to 9.01
|
—
|
—
|
—
|
|
Comparison of the SUV at up to 3 Tumor Sites
End of cycle 6
|
7.7 standard uptake value
Interval 6.33 to 9.34
|
—
|
—
|
—
|
|
Comparison of the SUV at up to 3 Tumor Sites
End of cycle 9
|
6.89 standard uptake value
Interval 5.39 to 8.74
|
—
|
—
|
—
|
|
Comparison of the SUV at up to 3 Tumor Sites
End of cycle 12
|
7.48 standard uptake value
Interval 5.68 to 9.76
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After completion of 3 cyclesPopulation: 29 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.
* Complete metabolic response (CMR)-complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions. * Partial metabolic response (PMR) * Target lesions: 20% or greater decrease in maximum SUV from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. * Non-target lesions: decrease in total number of non-target lesions, without complete resolution of metabolically active disease, or unequivocal decrease in degree of FDG activity within \>50% of the lesions. No unequivocal new lesions. * Stable metabolic disease (SMD): does not qualify for CMR, PMR, or PMD. * Progressive metabolic disease (PMD): * Unequivocal development of one more new metabolically active lesions * Target lesion: 20% or greater increase in maximum SUV from baseline. * Non-target lesions: unequivocal increase in FDG activity
Outcome measures
| Measure |
Dacarbazine
n=51 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Overall Tumor Metabolic Response
CMR
|
0 participants
|
—
|
—
|
—
|
|
Overall Tumor Metabolic Response
PMR
|
4 participants
|
—
|
—
|
—
|
|
Overall Tumor Metabolic Response
SMD
|
13 participants
|
—
|
—
|
—
|
|
Overall Tumor Metabolic Response
PMD
|
34 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After completion of 3 cyclesPopulation: 31 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.
Outcome measures
| Measure |
Dacarbazine
n=4 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
n=12 Participants
|
Progressive Metabolic Disease
n=33 Participants
|
Total
n=49 Participants
|
|---|---|---|---|---|
|
Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate
PR
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate
SD
|
2 participants
|
10 participants
|
8 participants
|
20 participants
|
|
Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate
PD
|
1 participants
|
2 participants
|
24 participants
|
27 participants
|
|
Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate
Total
|
4 participants
|
12 participants
|
33 participants
|
49 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Only 6 patients were evaluable for response at the end of 12 cycles.
Outcome measures
| Measure |
Dacarbazine
n=6 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Overall Disease Control Rate
Complete response
|
0 participants
|
—
|
—
|
—
|
|
Overall Disease Control Rate
Partial response
|
0 participants
|
—
|
—
|
—
|
|
Overall Disease Control Rate
Stable disease
|
5 participants
|
—
|
—
|
—
|
|
Overall Disease Control Rate
Progressive disease
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Until completion of follow-up (estimated to be 1 year)Population: 10 patient observations with invalid time or censoring values were not included.
-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Dacarbazine
n=70 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Time to Progression (TTP)
|
2.07 months
Interval 1.84 to 2.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Until completion of follow-up or patient death (estimated to be 1 year)Population: One patient with invalid time or censoring value was not included.
Outcome measures
| Measure |
Dacarbazine
n=79 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Overall Survival
|
8.09 months
Interval 5.56 to 9.74
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Completion of follow-up (estimated to be 1 year)Population: 29 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no anatomic response recorded.
-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Dacarbazine
n=51 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Correlate the Time to Progression With Best Anatomic Response
Progressive disease
|
1.97 months
Interval 1.84 to 2.07
|
—
|
—
|
—
|
|
Correlate the Time to Progression With Best Anatomic Response
Partial response
|
NA months
Interval 9.41 to
The median and upper confidence level were not estimable due to the limited number of events.
|
—
|
—
|
—
|
|
Correlate the Time to Progression With Best Anatomic Response
Stable disease
|
4.14 months
Interval 3.91 to 6.94
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Completion of follow-up (estimated to be 1 year)Population: 31 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.
-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Dacarbazine
n=49 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Correlate Time to Progression With Best Metabolic Response
Partial metabolic response
|
3.95 months
Interval 1.61 to
The upper confidence level was not estimable due to the limited number of events.
|
—
|
—
|
—
|
|
Correlate Time to Progression With Best Metabolic Response
Stable metabolic disease
|
5.30 months
Interval 2.53 to 9.41
|
—
|
—
|
—
|
|
Correlate Time to Progression With Best Metabolic Response
Progressive metabolic disease
|
2.07 months
Interval 1.84 to 2.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Completion of follow-up (estimated to be 1 year)Population: 26 patients were not evaluable for this outcome measure for various reasons including unknown survival status, progressive disease prior to cycle 3, no anatomic response noted, and toxicity.
Outcome measures
| Measure |
Dacarbazine
n=54 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Correlate Overall Survival With Best Anatomic Response
Partial response
|
18.16 months
The lower and upper confidence levels were not estimable due to the limited number of events. Only two patients had partial response and only one of them died within the time frame of the study.
|
—
|
—
|
—
|
|
Correlate Overall Survival With Best Anatomic Response
Stable disease
|
14.77 months
Interval 8.75 to 23.85
|
—
|
—
|
—
|
|
Correlate Overall Survival With Best Anatomic Response
Progressive disease
|
7.96 months
Interval 5.72 to 10.46
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Completion of follow-up (estimated to be 1 year)Population: 28 patients were not evaluable for this outcome measure due to various reason such as progressive disease prior to cycle 3, unknown survival status, no target lesion on PET scan, and toxicity.
Outcome measures
| Measure |
Dacarbazine
n=52 Participants
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
Stable Metabolic Disease
|
Progressive Metabolic Disease
|
Total
|
|---|---|---|---|---|
|
Correlate Overall Survival With Best Metabolic Response
Partial metabolic response
|
18.16 months
Interval 7.3 to 25.79
|
—
|
—
|
—
|
|
Correlate Overall Survival With Best Metabolic Response
Stable metabolic disease
|
18.59 months
Interval 6.91 to 44.01
|
—
|
—
|
—
|
|
Correlate Overall Survival With Best Metabolic Response
Progressive metabolic disease
|
8.75 months
Interval 6.05 to 12.8
|
—
|
—
|
—
|
Adverse Events
Dacarbazine
Serious adverse events
| Measure |
Dacarbazine
n=80 participants at risk
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
|---|---|
|
Infections and infestations
Upper respiratory infection
|
1.2%
1/80
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/80
|
|
General disorders
Disease progression
|
1.2%
1/80
|
|
General disorders
Death
|
1.2%
1/80
|
|
Injury, poisoning and procedural complications
Fracture
|
1.2%
1/80
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
4/80
|
|
Respiratory, thoracic and mediastinal disorders
Lung hemorrhage
|
1.2%
1/80
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/80
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
1/80
|
|
Nervous system disorders
Neuropathy - motor
|
1.2%
1/80
|
|
Gastrointestinal disorders
Abdominal hemorrhage
|
1.2%
1/80
|
|
Investigations
Thrombocytopenia
|
1.2%
1/80
|
|
Vascular disorders
Hypotension
|
1.2%
1/80
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.2%
1/80
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
1/80
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/80
|
|
Immune system disorders
Allergic reaction
|
1.2%
1/80
|
Other adverse events
| Measure |
Dacarbazine
n=80 participants at risk
Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nose hemorrhage
|
1.2%
1/80
|
|
Cardiac disorders
Palpitations
|
1.2%
1/80
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial effusion
|
1.2%
1/80
|
|
Metabolism and nutrition disorders
Phosphorus - low
|
3.8%
3/80
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.5%
2/80
|
|
Investigations
Platelets
|
41.2%
33/80
|
|
Gastrointestinal disorders
Abodominal pain
|
11.2%
9/80
|
|
Metabolism and nutrition disorders
Acidosis
|
1.2%
1/80
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
1.2%
1/80
|
|
Metabolism and nutrition disorders
Albumin - low
|
33.8%
27/80
|
|
Investigations
Alkaline phosphatase
|
23.8%
19/80
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
2.5%
2/80
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
5/80
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
4/80
|
|
Eye disorders
Anisocoria
|
1.2%
1/80
|
|
Gastrointestinal disorders
Anorexia
|
15.0%
12/80
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/80
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/80
|
|
Investigations
Bilirubin
|
5.0%
4/80
|
|
Gastrointestinal disorders
Bloating
|
1.2%
1/80
|
|
Infections and infestations
Boil
|
2.5%
2/80
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
28.7%
23/80
|
|
Cardiac disorders
Brachycardia
|
1.2%
1/80
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm: wheezing
|
2.5%
2/80
|
|
Injury, poisoning and procedural complications
Bruising
|
2.5%
2/80
|
|
Metabolism and nutrition disorders
Calcium - high
|
2.5%
2/80
|
|
Metabolism and nutrition disorders
Calcium - low
|
36.2%
29/80
|
|
Cardiac disorders
Chest pain
|
6.2%
5/80
|
|
General disorders
Chills
|
1.2%
1/80
|
|
Nervous system disorders
Cognitive disturbance
|
1.2%
1/80
|
|
General disorders
Cold sore
|
1.2%
1/80
|
|
Psychiatric disorders
Confusion
|
2.5%
2/80
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
2.5%
2/80
|
|
Gastrointestinal disorders
Constipation
|
23.8%
19/80
|
|
Musculoskeletal and connective tissue disorders
Contracture
|
1.2%
1/80
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
12/80
|
|
Investigations
Creatinine
|
13.8%
11/80
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
1.2%
1/80
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
3/80
|
|
Psychiatric disorders
Delirium
|
1.2%
1/80
|
|
Psychiatric disorders
Depression
|
1.2%
1/80
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
1.2%
1/80
|
|
Gastrointestinal disorders
Diarrhea
|
16.2%
13/80
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease pain
|
21.2%
17/80
|
|
Nervous system disorders
Dizziness
|
3.8%
3/80
|
|
Gastrointestinal disorders
Dry mouth
|
1.2%
1/80
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
2.5%
2/80
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
15/80
|
|
General disorders
Edema
|
27.5%
22/80
|
|
Investigations
Elevated PTT
|
7.5%
6/80
|
|
Investigations
Elevated troponin I
|
1.2%
1/80
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
1/80
|
|
Gastrointestinal disorders
Esophageal obstruction
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
3.8%
3/80
|
|
General disorders
Face pain
|
1.2%
1/80
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
2/80
|
|
General disorders
Fatigue
|
53.8%
43/80
|
|
General disorders
Fever
|
6.2%
5/80
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
2/80
|
|
Eye disorders
Floaters
|
1.2%
1/80
|
|
General disorders
Flu like syndrome
|
2.5%
2/80
|
|
Renal and urinary disorders
Frothy urine
|
1.2%
1/80
|
|
Gastrointestinal disorders
GI abdominal hemorrhage
|
3.8%
3/80
|
|
Metabolism and nutrition disorders
Glucose - high
|
27.5%
22/80
|
|
Metabolism and nutrition disorders
Glucose - low
|
6.2%
5/80
|
|
Musculoskeletal and connective tissue disorders
Gout
|
2.5%
2/80
|
|
Nervous system disorders
Headache
|
5.0%
4/80
|
|
Vascular disorders
Hematoma
|
1.2%
1/80
|
|
Renal and urinary disorders
Hematuria
|
1.2%
1/80
|
|
Blood and lymphatic system disorders
Hemoglobin
|
71.2%
57/80
|
|
Vascular disorders
Hot flashes
|
3.8%
3/80
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.2%
1/80
|
|
Vascular disorders
Hypertension
|
6.2%
5/80
|
|
Investigations
Hypertriglyceridemia
|
1.2%
1/80
|
|
Investigations
INR
|
11.2%
9/80
|
|
Vascular disorders
Inferior vena cava thrombus
|
1.2%
1/80
|
|
Psychiatric disorders
Insomnia
|
7.5%
6/80
|
|
Musculoskeletal and connective tissue disorders
Intraspinal hematoma
|
1.2%
1/80
|
|
Eye disorders
Keratitis
|
1.2%
1/80
|
|
Investigations
Leukocytes (WBC)
|
30.0%
24/80
|
|
Investigations
Lymphopenia
|
67.5%
54/80
|
|
Nervous system disorders
Memory impairment
|
1.2%
1/80
|
|
Psychiatric disorders
Mood alteration - agitation
|
1.2%
1/80
|
|
Psychiatric disorders
Mood alteration - anxiety
|
3.8%
3/80
|
|
Gastrointestinal disorders
Mucositis
|
3.8%
3/80
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
3/80
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/80
|
|
Gastrointestinal disorders
Nausea
|
22.5%
18/80
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
1/80
|
|
Nervous system disorders
Neuropathy (sensory)
|
8.8%
7/80
|
|
Infections and infestations
Neutropenic fever
|
1.2%
1/80
|
|
Investigations
Neutrophils (ANC)
|
18.8%
15/80
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
3/80
|
|
Respiratory, thoracic and mediastinal disorders
Pnemonia
|
5.0%
4/80
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/80
|
|
Vascular disorders
Portal vein thrombosis
|
1.2%
1/80
|
|
Metabolism and nutrition disorders
Potassium - high
|
5.0%
4/80
|
|
Metabolism and nutrition disorders
Potassium - low
|
15.0%
12/80
|
|
Renal and urinary disorders
Proteinuria
|
2.5%
2/80
|
|
Vascular disorders
Pulmonary embolism
|
1.2%
1/80
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
2.5%
2/80
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
4/80
|
|
Gastrointestinal disorders
Reflux gastritis
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.2%
1/80
|
|
Investigations
SGOT (AST)
|
20.0%
16/80
|
|
Investigations
SGPT (ALT)
|
18.8%
15/80
|
|
Nervous system disorders
Seizure
|
3.8%
3/80
|
|
Musculoskeletal and connective tissue disorders
Shoulder/back pain
|
5.0%
4/80
|
|
Infections and infestations
Sinusitis
|
1.2%
1/80
|
|
Metabolism and nutrition disorders
Sodium - high
|
7.5%
6/80
|
|
Metabolism and nutrition disorders
Sodium - low
|
26.2%
21/80
|
|
Nervous system disorders
Speech impairment
|
1.2%
1/80
|
|
General disorders
Swelling - face
|
1.2%
1/80
|
|
Cardiac disorders
Tachycardia
|
6.2%
5/80
|
|
Gastrointestinal disorders
Taste alterations
|
3.8%
3/80
|
|
Infections and infestations
Thrush
|
1.2%
1/80
|
|
Gastrointestinal disorders
Ulcer: GI duodenum
|
1.2%
1/80
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
5/80
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
2.5%
2/80
|
|
Infections and infestations
Urinary tract infection
|
6.2%
5/80
|
|
Renal and urinary disorders
Urine color change
|
1.2%
1/80
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
1.2%
1/80
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
12/80
|
|
Investigations
Weight loss
|
3.8%
3/80
|
Additional Information
Brian Van Tine, M.D., Ph.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place