Trial Outcomes & Findings for Docetaxel, Thalidomide, Prednisone, and Bevacizumab to Treat Metastatic Prostate Cancer (NCT NCT00089609)
NCT ID: NCT00089609
Last Updated: 2018-04-20
Results Overview
PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
21.6 months
Results posted on
2018-04-20
Participant Flow
Participant milestones
| Measure |
Main Cohort - Prostate Cancer
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
13
|
|
Overall Study
COMPLETED
|
57
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Main Cohort - Prostate Cancer
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Docetaxel, Thalidomide, Prednisone, and Bevacizumab to Treat Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Main Cohort - Prostate Cancer
n=60 Participants
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
n=13 Participants
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Continuous
|
65.35 years
STANDARD_DEVIATION 7.81 • n=5 Participants
|
63.31 years
STANDARD_DEVIATION 8.74 • n=7 Participants
|
64.98 years
STANDARD_DEVIATION 7.96 • 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
|
60 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
62 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21.6 monthsPopulation: The main cohort was designed to evaluate clinical progression and the expansion cohort was designed to evaluate immune response. Thus the expansion cohort is not included here.
PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression.
Outcome measures
| Measure |
Main Cohort - Prostate Cancer
n=60 Participants
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
|
|---|---|---|
|
Number of Participants Who Had a Prostate-specific Antigen (PSA) Response
|
52 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Cellular immune response and cytokines were not analyzed as the study outcomes were concentrated on the dual-anti-angiogenesis inhibition properties of the regimen and not immunomodulatory changes.
Cellular immune response and cytokines were evaluated after two cycles of therapy in the expansion cohort. Those cycles included treatment with bevacizumab and docetaxel as a pre-medication.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 37 monthsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Main Cohort - Prostate Cancer
n=60 Participants
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
n=13 Participants
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
60 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: up to 40 monthsPopulation: Per protocol, time to progression using Bubley Criteria was not assessed for the expansion cohort.
Time to disease progression was based on the Prostate-Specific Antigen (PSA) Working Group 1 Criteria (Bubley Criteria) and standard Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. Per the criteria, investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period.
Outcome measures
| Measure |
Main Cohort - Prostate Cancer
n=60 Participants
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
|
|---|---|---|
|
Time to Progression Using Bubley Criteria
|
18.3 Months
Interval 0.0 to 40.0
|
—
|
SECONDARY outcome
Timeframe: up to 34 monthsPopulation: Only 33/60 participants had measurable disease and were evaluable for this outcome measure. Per protocol, disease progression by clinical and radiographic criteria without the use of PSA was not assessed for the expansion cohort.
Clinical and radiographic response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded or the appearance of one or more new lesions.
Outcome measures
| Measure |
Main Cohort - Prostate Cancer
n=33 Participants
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
|
|---|---|---|
|
Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)
Progressive Disease (PD)
|
1 Participants
|
—
|
|
Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)
Complete Response (CR)
|
2 Participants
|
—
|
|
Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)
Partial Response (PR)
|
19 Participants
|
—
|
|
Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)
Stable Disease (SD)
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: 34 monthsPopulation: Per protocol, this outcome was not assessed for the expansion cohort.
From on study date to date of death at 34 months.
Outcome measures
| Measure |
Main Cohort - Prostate Cancer
n=60 Participants
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
|
|---|---|---|
|
Number of Participants Who Died After a Follow Up of 34 Months Following Treatment
|
38 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on C1D1, 5 minutes before the end of infusion, and 15, and 30 minutes, and 1, 2,4,8, and 24 hours after the end of infusionPopulation: The outcome was not assessed as the analysis of plasma bevacizumab concentrations was the main pharmacokinetic secondary outcome in the study. The plasma levels of docetaxel and thalidomide (without bevacizumab) had minimal significance in this study. Analysis of plasma concentrations of docetaxel and thalidomide will not be done.
The analysis will be performed using a validated method based on liquid chromatography with mass-spectrometric detection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at 6 weeks (after two cycles of treatment)Population: Only 17/60 participants were evaluable for this outcome. Per protocol CAECs were not assessed in the expansion cohort.
The assay utilized has no standard curve. Categorizing patients with ≥ 75% PSA decline in one group and \< PSA decline in another group, every patient is their own control with comparison of CAEC at baseline vs. 6 weeks (after two cycles of treatment). Blood is drawn from the patient and a million viable mononuclear cells are counted and then it is determined how many CAECs are in the specimen. The cell count is then compared from baseline to post 2 cycles of treatment. Thus, "significant increase" is dependent upon this comparison and varies between patients.
Outcome measures
| Measure |
Main Cohort - Prostate Cancer
n=14 Participants
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
n=3 Participants
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
|
|---|---|---|
|
Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Patient entry onto the studyPopulation: The outcome was not assessed as the clinical significance of cytochrome P450 2C19 polymorphism in angiogenesis is undetermined. This analysis will not be pursued.
Single nucleotide polymorphisms in genes that play an important role in eliminations pathways for docetaxel (in the CYP3A4 and CYP3A5 genes) and thalidomide (CYP2C19) will be evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at 3 month intervals until progressionPopulation: The outcome was not assessed as the functionality of dynamic MRI in prostate cancer was poor at the time of this study. Earlier prostate MRI techniques suffered from poor sensitivity and specificity for monitoring progression.
Target lesions in the bone or soft tissues will be identified from the participant computed tomography (CT) scan. Dynamic MRI will be performed after the intravenous administration of 0.1 mmol/kg of Gadolinium chelate. Progression is defined by the RECIST criteria and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment starts or the appearance of new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and monthlyPopulation: The outcome was not assessed. In the study, assessment of circulating apoptotic endothelial cells was the main outcome evaluated for assessing the treatment's antiangiogenic activity. Changes in the molecular markers of angiogenesis will not be pursued.
Outcome measures
Outcome data not reported
Adverse Events
Main Cohort - Prostate Cancer
Serious events: 48 serious events
Other events: 60 other events
Deaths: 35 deaths
Expansion Cohort - Prostate Cancer
Serious events: 4 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Main Cohort - Prostate Cancer
n=60 participants at risk
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
n=13 participants at risk
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
|
|---|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
3.3%
2/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Cardiac arrhythmia - Other, Specify, new onset of A. fib
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Cardiac general - Other, Specify, aortic dissection
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
General disorders
Death not associated with CTCAE term::Death NOS
|
15.0%
9/60 • Number of events 9 • 37 months
|
0.00%
0/13 • 37 months
|
|
General disorders
Death not associated with CTCAE term: Death Progression NOS
|
41.7%
25/60 • Number of events 25 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Dehydration
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Febrile neutropenia
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/60 • Number of events 1 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Metabolism and nutrition disorders
Hemoglobin
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Hemorrhage, GI: Abdomen NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Hemorrhage, GI: Colon
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Hemorrhage, GI: Upper GI NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Hypertension
|
3.3%
2/60 • Number of events 2 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Cardiac disorders
Hypotension
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Abdomen NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Anal/perianal
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
6.7%
4/60 • Number of events 4 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with unknown ANC: Urinary tract NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
Neurology-Other (somnolence
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AG)
|
6.7%
4/60 • Number of events 4 • 37 months
|
0.00%
0/13 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Pain::Cardiac/heart
|
1.7%
1/60 • Number of events 1 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Blood and lymphatic system disorders
Platelets
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
1.7%
1/60 • Number of events 1 • 37 months
|
7.7%
1/13 • Number of events 2 • 37 months
|
|
Metabolism and nutrition disorders
Proteinuria
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Atrial fibrillation
|
3.3%
2/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Nodal/Junctional
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Nervous system disorders
Syncope (fainting)
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Vascular disorders
Vessel injury-artery: Aorta
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 2 • 37 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Infections and infestations
Infection with unknown ANC: Wound
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (acute kidney injury; chronic kidney disease)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection - Other (sepsis)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
General disorders
Death not associated with CTCAE term: Death, Progression NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
Other adverse events
| Measure |
Main Cohort - Prostate Cancer
n=60 participants at risk
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
|
Expansion Cohort - Prostate Cancer
n=13 participants at risk
Docetaxel 75 mg/m\^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
|
|---|---|---|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Nerve-peripheral
|
1.7%
1/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Nose
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Oral cavity-gums (gingivitis)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:paranasal
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Sinus
|
8.3%
5/60 • Number of events 5 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Skin (cellulitis)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Ungual (nails)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Upper airway NOS
|
3.3%
2/60 • Number of events 2 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Urinary tract NOS
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with unknown ANC::Middle ear (otitis media)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with unknown ANC::Oral cavity-gums (gingivitis)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with unknown ANC:Sinus
|
3.3%
2/60 • Number of events 2 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Infections and infestations
Infection with unknown ANC::Skin (cellulitis)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with unknown ANC::Soft tissue NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with unknown ANC::Ungual (nails)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with unknown ANC::Upper airway NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Infections and infestations
Infection with unknown ANC::Urinary tract NOS
|
3.3%
2/60 • Number of events 2 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Psychiatric disorders
Insomnia
|
3.3%
2/60 • Number of events 2 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
60.0%
36/60 • Number of events 74 • 37 months
|
84.6%
11/13 • Number of events 27 • 37 months
|
|
Metabolism and nutrition disorders
Lipase
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Eye disorders
Keratitis (corneal inflammatory/corneal ulceration)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
23.3%
14/60 • Number of events 20 • 37 months
|
15.4%
2/13 • Number of events 8 • 37 months
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
23.3%
14/60 • Number of events 28 • 37 months
|
15.4%
2/13 • Number of events 6 • 37 months
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
68.3%
41/60 • Number of events 97 • 37 months
|
38.5%
5/13 • Number of events 7 • 37 months
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
20.0%
12/60 • Number of events 19 • 37 months
|
15.4%
2/13 • Number of events 8 • 37 months
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
6.7%
4/60 • Number of events 4 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
11.7%
7/60 • Number of events 7 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Gastrointestinal disorders
Anorexia
|
11.7%
7/60 • Number of events 8 • 37 months
|
23.1%
3/13 • Number of events 4 • 37 months
|
|
Nervous system disorders
Ataxia (incoordination)
|
10.0%
6/60 • Number of events 10 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
6.7%
4/60 • Number of events 6 • 37 months
|
7.7%
1/13 • Number of events 4 • 37 months
|
|
Renal and urinary disorders
Bladder spasms
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Blood and lymphatic system disorders
Blood/Bone marrow - Other (Specify)
|
1.7%
1/60 • Number of events 1 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
13.3%
8/60 • Number of events 8 • 37 months
|
0.00%
0/13 • 37 months
|
|
Injury, poisoning and procedural complications
Burn
|
1.7%
1/60 • Number of events 1 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
11.7%
7/60 • Number of events 9 • 37 months
|
7.7%
1/13 • Number of events 2 • 37 months
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
36.7%
22/60 • Number of events 36 • 37 months
|
23.1%
3/13 • Number of events 4 • 37 months
|
|
Cardiac disorders
Cardiac arrhythmia - Other, Specify,
|
5.0%
3/60 • Number of events 3 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Cardiac disorders
Cardiac general - Other, Specify,
|
5.0%
3/60 • Number of events 3 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Gastrointestinal disorders
Chelitis
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Blood and lymphatic system disorders
Coagulation - Other (Specify)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
Cognitive disturbance
|
5.0%
3/60 • Number of events 3 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
General disorders
Constitutional Symptoms-Other (Specify,_____)
|
5.0%
3/60 • Number of events 4 • 37 months
|
0.00%
0/13 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
10/60 • Number of events 16 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Metabolism and nutrition disorders
Creatinine
|
1.7%
1/60 • Number of events 1 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Immune system disorders
Cytokine release syndrome/acute infusion reaction
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Dehydration
|
5.0%
3/60 • Number of events 7 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Dental: periodontal disease
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Dental: teeth
|
6.7%
4/60 • Number of events 4 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Blood and lymphatic system disorders
Dermal change lymphedema, phlebolymphedema
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Diarrhea
|
35.0%
21/60 • Number of events 24 • 37 months
|
46.2%
6/13 • Number of events 9 • 37 months
|
|
Nervous system disorders
Dizziness
|
28.3%
17/60 • Number of events 22 • 37 months
|
23.1%
3/13 • Number of events 3 • 37 months
|
|
Eye disorders
Dry eye syndrome
|
10.0%
6/60 • Number of events 7 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
36.7%
22/60 • Number of events 22 • 37 months
|
0.00%
0/13 • 37 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
12/60 • Number of events 12 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
5.0%
3/60 • Number of events 3 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
43.3%
26/60 • Number of events 37 • 37 months
|
23.1%
3/13 • Number of events 3 • 37 months
|
|
Blood and lymphatic system disorders
Edema: limb
|
21.7%
13/60 • Number of events 17 • 37 months
|
38.5%
5/13 • Number of events 6 • 37 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
86.7%
52/60 • Number of events 76 • 37 months
|
84.6%
11/13 • Number of events 23 • 37 months
|
|
Infections and infestations
Febrile Neutropenia
|
21.7%
13/60 • Number of events 15 • 37 months
|
0.00%
0/13 • 37 months
|
|
General disorders
Fever
|
10.0%
6/60 • Number of events 9 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Immune system disorders
Flu-like symptoms
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Skin and subcutaneous tissue disorders
Flushing
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
5.0%
3/60 • Number of events 3 • 37 months
|
38.5%
5/13 • Number of events 7 • 37 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
5.0%
3/60 • Number of events 8 • 37 months
|
7.7%
1/13 • Number of events 5 • 37 months
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
51.7%
31/60 • Number of events 33 • 37 months
|
38.5%
5/13 • Number of events 5 • 37 months
|
|
Ear and labyrinth disorders
Hearing: patients with/without baseline auidgram and not enrolled in a monitoring program)
|
3.3%
2/60 • Number of events 2 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
6.7%
4/60 • Number of events 4 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Hemorrhage, GI: Abdomen NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
8.3%
5/60 • Number of events 5 • 37 months
|
0.00%
0/13 • 37 months
|
|
Renal and urinary disorders
Hemorrhage, GU: Bladder
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Renal and urinary disorders
Hemorrhage, GU: Urethra
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Renal and urinary disorders
Hemorrhage, GU: Urinary NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Nose
|
31.7%
19/60 • Number of events 32 • 37 months
|
38.5%
5/13 • Number of events 7 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Respiratory tract NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Endocrine disorders
Hot flashes/flushes
|
10.0%
6/60 • Number of events 7 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Hypertension
|
28.3%
17/60 • Number of events 20 • 37 months
|
30.8%
4/13 • Number of events 5 • 37 months
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Hypotension
|
11.7%
7/60 • Number of events 7 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Incontinence, anal
|
8.3%
5/60 • Number of events 5 • 37 months
|
0.00%
0/13 • 37 months
|
|
Renal and urinary disorders
Incontinence, urinary
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection
|
1.7%
1/60 • Number of events 1 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Infections and infestations
Infection - Other, Specify
|
5.0%
3/60 • Number of events 4 • 37 months
|
15.4%
2/13 • Number of events 3 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Anal/perianal
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Blood
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Conjuctiva
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Larynx
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Lung (pneumonia)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Middle ear (otitis media)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:Muscle (infection myositis)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
61.7%
37/60 • Number of events 160 • 37 months
|
69.2%
9/13 • Number of events 35 • 37 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
11.7%
7/60 • Number of events 8 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
Memory impairment
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Nervous system disorders
Mood alteration-agitation
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
Mood alteration::Anxiety
|
1.7%
1/60 • Number of events 1 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Nervous system disorders
Mood alteration::Depression
|
10.0%
6/60 • Number of events 9 • 37 months
|
7.7%
1/13 • Number of events 2 • 37 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
10.0%
6/60 • Number of events 7 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Espophagus
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
5.0%
3/60 • Number of events 4 • 37 months
|
0.00%
0/13 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower
|
10.0%
6/60 • Number of events 8 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Left-sided
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::trunk
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
|
13.3%
8/60 • Number of events 8 • 37 months
|
0.00%
0/13 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue - Other (Specify,)
|
1.7%
1/60 • Number of events 1 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Myositis (inflammation/damage of muscle)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
48.3%
29/60 • Number of events 31 • 37 months
|
53.8%
7/13 • Number of events 9 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
41.7%
25/60 • Number of events 27 • 37 months
|
23.1%
3/13 • Number of events 3 • 37 months
|
|
Gastrointestinal disorders
Nausea
|
15.0%
9/60 • Number of events 10 • 37 months
|
30.8%
4/13 • Number of events 9 • 37 months
|
|
Nervous system disorders
Neurology-Other (Specify,______)
|
16.7%
10/60 • Number of events 14 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
Neuropathy - cranial::CN IX Motor-pharynx; sensory-ear, pharynx tongue
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
Neuropathy - cranial::CN V Motor-jaw muscles; sensory-facial
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
Neuropathy - cranial::CN VIII Hearing and balance
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
Neuropathy: motor
|
15.0%
9/60 • Number of events 11 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Nervous system disorders
Neuropathy: sensory
|
75.0%
45/60 • Number of events 65 • 37 months
|
46.2%
6/13 • Number of events 9 • 37 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
58.3%
35/60 • Number of events 71 • 37 months
|
84.6%
11/13 • Number of events 29 • 37 months
|
|
Eye disorders
Ocular/Visual-Other (Specify,___)
|
5.0%
3/60 • Number of events 3 • 37 months
|
15.4%
2/13 • Number of events 3 • 37 months
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
18.3%
11/60 • Number of events 12 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
20.0%
12/60 • Number of events 24 • 37 months
|
7.7%
1/13 • Number of events 3 • 37 months
|
|
General disorders
Pain-Other (Specify,R leg pain; shoulder pain; tooth pain; jaw)
|
21.7%
13/60 • Number of events 18 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
3.3%
2/60 • Number of events 2 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
18.3%
11/60 • Number of events 12 • 37 months
|
46.2%
6/13 • Number of events 6 • 37 months
|
|
Cardiac disorders
Pain::Cardiac/heart
|
1.7%
1/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Pain::Chest wall
|
3.3%
2/60 • Number of events 2 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Cardiac disorders
Pain::Chest/thorax NOS
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
10.0%
6/60 • Number of events 6 • 37 months
|
0.00%
0/13 • 37 months
|
|
Skin and subcutaneous tissue disorders
Pain: Face
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
Pain::Head/headache
|
11.7%
7/60 • Number of events 9 • 37 months
|
23.1%
3/13 • Number of events 5 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
8.3%
5/60 • Number of events 6 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
11.7%
7/60 • Number of events 9 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Pain::Oral cavity
|
6.7%
4/60 • Number of events 4 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Pain::Oral gums
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
General disorders
Pain::Pain NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Reproductive system and breast disorders
Pain::Pelvis
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Pain::Rectum
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Throat/pharynx/larynx
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Palpitations
|
3.3%
2/60 • Number of events 2 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Perforation, GI::Colon
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
3.3%
2/60 • Number of events 2 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
40.0%
24/60 • Number of events 54 • 37 months
|
38.5%
5/13 • Number of events 19 • 37 months
|
|
Blood and lymphatic system disorders
Platelets
|
21.7%
13/60 • Number of events 21 • 37 months
|
15.4%
2/13 • Number of events 5 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
23.3%
14/60 • Number of events 17 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
25.0%
15/60 • Number of events 20 • 37 months
|
30.8%
4/13 • Number of events 8 • 37 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
8.3%
5/60 • Number of events 7 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Proteinuria
|
16.7%
10/60 • Number of events 17 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, )
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
21.7%
13/60 • Number of events 14 • 37 months
|
53.8%
7/13 • Number of events 8 • 37 months
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
18.3%
11/60 • Number of events 14 • 37 months
|
0.00%
0/13 • 37 months
|
|
Renal and urinary disorders
Renal/Genitourinary-Other (Specify)
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Eye disorders
Scleral necrosis/meli
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
5.0%
3/60 • Number of events 4 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
15.0%
9/60 • Number of events 14 • 37 months
|
15.4%
2/13 • Number of events 5 • 37 months
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Atrial fibrillation
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus bradycardia
|
1.7%
1/60 • Number of events 1 • 37 months
|
7.7%
1/13 • Number of events 2 • 37 months
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
3.3%
2/60 • Number of events 2 • 37 months
|
15.4%
2/13 • Number of events 2 • 37 months
|
|
Nervous system disorders
Syncope (fainting)
|
13.3%
8/60 • Number of events 15 • 37 months
|
7.7%
1/13 • Number of events 2 • 37 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
55.0%
33/60 • Number of events 38 • 37 months
|
61.5%
8/13 • Number of events 9 • 37 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
3/60 • Number of events 4 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Nervous system disorders
Tremor
|
13.3%
8/60 • Number of events 8 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Ulcer, GI: Rectum
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
5.0%
3/60 • Number of events 4 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 5 • 37 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
11.7%
7/60 • Number of events 7 • 37 months
|
0.00%
0/13 • 37 months
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
3.3%
2/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Cardiac disorders
Vasovagal episode
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Vascular disorders
Vessel injury-vein: Extremity-lower
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Vascular disorders
Vessel injury-vein: Other NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Eye disorders
Vision-blurred vision
|
15.0%
9/60 • Number of events 10 • 37 months
|
0.00%
0/13 • 37 months
|
|
Eye disorders
Vision-flashing lights/floaters
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
21.7%
13/60 • Number of events 14 • 37 months
|
0.00%
0/13 • 37 months
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
6/60 • Number of events 7 • 37 months
|
30.8%
4/13 • Number of events 4 • 37 months
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
43.3%
26/60 • Number of events 32 • 37 months
|
53.8%
7/13 • Number of events 8 • 37 months
|
|
General disorders
Weight gain
|
5.0%
3/60 • Number of events 3 • 37 months
|
15.4%
2/13 • Number of events 3 • 37 months
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
3.3%
2/60 • Number of events 2 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
General disorders
Weight loss
|
16.7%
10/60 • Number of events 15 • 37 months
|
7.7%
1/13 • Number of events 2 • 37 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify,_____)
|
15.0%
9/60 • Number of events 14 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Hemoglobin
|
58.3%
35/60 • Number of events 153 • 37 months
|
61.5%
8/13 • Number of events 23 • 37 months
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - other (Specify)
|
10.0%
6/60 • Number of events 8 • 37 months
|
0.00%
0/13 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-upper
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/60 • Number of events 2 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Gastrointestinal disorders
Constipation
|
76.7%
46/60 • Number of events 64 • 37 months
|
61.5%
8/13 • Number of events 10 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
5.0%
3/60 • Number of events 3 • 37 months
|
0.00%
0/13 • 37 months
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically): dental tooth
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically): upper airway NOS
|
3.3%
2/60 • Number of events 2 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically): urinary tract NOS
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically): cellulitis
|
1.7%
1/60 • Number of events 1 • 37 months
|
0.00%
0/13 • 37 months
|
|
Renal and urinary disorders
Obstruction, GU: Ureter
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
|
Renal and urinary disorders
Obstruction, GU: Urethra
|
0.00%
0/60 • 37 months
|
7.7%
1/13 • Number of events 1 • 37 months
|
Additional Information
Ravi Madan, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-480-7168
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place