Trial Outcomes & Findings for Sunitinib to Treat Recurrent Brain Cancer (NCT NCT00923117)
NCT ID: NCT00923117
Last Updated: 2015-09-30
Results Overview
Time between the start of treatment to progression. Progression is defined by the RANO(Response Assessment in Neuro-Oncology) criteria. Progression is defined by any of the following: 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
6 months
Results posted on
2015-09-30
Participant Flow
Participant milestones
| Measure |
Bevacizumab Resistant Patients
Patients who had tumor progression while treated with bevacizumab. Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
|
Bevacizumab Naive Patients
Patients with progressive tumor who have not been treated with bevacizumab.Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
COMPLETED
|
44
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sunitinib to Treat Recurrent Brain Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab Resistant Patients
n=44 Participants
Patients who had tumor progression while treated with bevacizumab.
|
Bevacizumab Naive Patients
n=43 Participants
Patients with progressive tumor who have not been treated with bevacizumab.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Age, Continuous
|
51.63 years
STANDARD_DEVIATION 12.36 • n=93 Participants
|
50.38 years
STANDARD_DEVIATION 13.88 • n=4 Participants
|
51.01 years
STANDARD_DEVIATION 13.07 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=93 Participants
|
43 participants
n=4 Participants
|
87 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 63 patients enrolled with glioblastoma multiforme (GBM) (32 Bev naive, 31 Bev resistant) and were evaluated for this outcome measure.
Time between the start of treatment to progression. Progression is defined by the RANO(Response Assessment in Neuro-Oncology) criteria. Progression is defined by any of the following: 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.
Outcome measures
| Measure |
Bevacizumab Resistant Patients
n=31 Participants
Patients who had tumor progression while treated with bevacizumab.
|
Bevacizumab Naive Patients
n=32 Participants
Patients with progressive tumor who have not been treated with bevacizumab.
|
|---|---|---|
|
6-month Progression-free Survival.
|
0.92 Months
Interval 0.89 to 0.92
|
1.08 Months
Interval 0.92 to 2.47
|
SECONDARY outcome
Timeframe: 7/2/08 -12/6/13Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Bevacizumab Resistant Patients
n=44 Participants
Patients who had tumor progression while treated with bevacizumab.
|
Bevacizumab Naive Patients
n=43 Participants
Patients with progressive tumor who have not been treated with bevacizumab.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
44 Participants
|
43 Participants
|
Adverse Events
Bevacizumab Resistant Patients
Serious events: 16 serious events
Other events: 44 other events
Deaths: 0 deaths
Bevacizumab Naive Patients
Serious events: 13 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab Resistant Patients
n=44 participants at risk
Patients who had tumor progression while treated with bevacizumab.
|
Bevacizumab Naive Patients
n=43 participants at risk
Patients with progressive tumor who have not been treated with bevacizumab.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Blood and lymphatic system disorders
Hemorrhage, CNS
|
4.5%
2/44 • Number of events 2
|
0.00%
0/43
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory: Nose
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Cardiac disorders
Hypertension
|
4.5%
2/44 • Number of events 2
|
0.00%
0/43
|
|
Cardiac disorders
Hypotension
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Infections and infestations
Infection
|
4.5%
2/44 • Number of events 2
|
0.00%
0/43
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
4.5%
2/44 • Number of events 3
|
0.00%
0/43
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-upper
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Gastrointestinal disorders
Nausea
|
4.5%
2/44 • Number of events 2
|
0.00%
0/43
|
|
Nervous system disorders
Neurology - other (herniation)
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
4.5%
2/44 • Number of events 3
|
0.00%
0/43
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 lymphopenia
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Hepatobiliary disorders
Pancreatitis
|
2.3%
1/44 • Number of events 2
|
0.00%
0/43
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
3/44 • Number of events 3
|
0.00%
0/43
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
General disorders
Death not associated with CTCAE term: Death NOS
|
2.3%
1/44 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term: Disease progression NOS
|
9.1%
4/44 • Number of events 4
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
2.3%
1/44 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal-Other (hemorrhoids)
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
0.00%
0/44
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Pain: Head/Headache
|
2.3%
1/44 • Number of events 1
|
4.7%
2/43 • Number of events 3
|
|
Nervous system disorders
Seizure
|
6.8%
3/44 • Number of events 3
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Speech impairment (e.g. dysphasia or aphasia)
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Supraventricular & nodal arrhythmia: Sinus tachycardia
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.3%
1/44 • Number of events 1
|
9.3%
4/43 • Number of events 4
|
|
Hepatobiliary disorders
Cholecystitis
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Gastrointestinal disorders
Dehydration
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
Other adverse events
| Measure |
Bevacizumab Resistant Patients
n=44 participants at risk
Patients who had tumor progression while treated with bevacizumab.
|
Bevacizumab Naive Patients
n=43 participants at risk
Patients with progressive tumor who have not been treated with bevacizumab.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
29.5%
13/44 • Number of events 14
|
16.3%
7/43 • Number of events 11
|
|
Cardiac disorders
Hypertension
|
54.5%
24/44 • Number of events 25
|
30.2%
13/43 • Number of events 18
|
|
Metabolism and nutrition disorders
ALT/SGPT (serum glutamic pyruvic transaminase)
|
47.7%
21/44 • Number of events 25
|
48.8%
21/43 • Number of events 30
|
|
Metabolism and nutrition disorders
AST/SGOT (serum glutamic oxaloacetic transaminase)
|
27.3%
12/44 • Number of events 16
|
23.3%
10/43 • Number of events 10
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
45.5%
20/44 • Number of events 23
|
44.2%
19/43 • Number of events 24
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
11.4%
5/44 • Number of events 5
|
14.0%
6/43 • Number of events 6
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
18.2%
8/44 • Number of events 10
|
20.9%
9/43 • Number of events 10
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
2.3%
1/44 • Number of events 1
|
9.3%
4/43 • Number of events 4
|
|
Cardiac disorders
Cardiac General - Other (mitral valve disease)
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Cardiac disorders
Cardiac troponin T (cTnT)
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
2.3%
1/44 • Number of events 1
|
4.7%
2/43 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
4.5%
2/44 • Number of events 2
|
11.6%
5/43 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine
|
13.6%
6/44 • Number of events 8
|
2.3%
1/43 • Number of events 1
|
|
Endocrine disorders
Cushingoid appearance (e.g. moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (skin tear)
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.3%
1/44 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Edema: limb
|
2.3%
1/44 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
18.2%
8/44 • Number of events 9
|
25.6%
11/43 • Number of events 11
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/44
|
4.7%
2/43 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal-Other (tongue irritation, soreness)
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hypoglycemia)
|
2.3%
1/44 • Number of events 1
|
9.3%
4/43 • Number of events 5
|
|
Gastrointestinal disorders
Heartburn/Dyspepsia
|
9.1%
4/44 • Number of events 4
|
11.6%
5/43 • Number of events 5
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
11/44 • Number of events 15
|
34.9%
15/43 • Number of events 21
|
|
Blood and lymphatic system disorders
Hemorrhage, CNS
|
2.3%
1/44 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage, GI: Anus
|
0.00%
0/44
|
4.7%
2/43 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemorrhage, GI: oral cavity
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory: Nose
|
6.8%
3/44 • Number of events 3
|
7.0%
3/43 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.3%
1/44 • Number of events 2
|
2.3%
1/43 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
2.3%
1/44 • Number of events 1
|
14.0%
6/43 • Number of events 6
|
|
Cardiac disorders
Hypotension
|
0.00%
0/44
|
4.7%
2/43 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lip/perioral
|
2.3%
1/44 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
2.3%
1/44 • Number of events 1
|
4.7%
2/43 • Number of events 2
|
|
Infections and infestations
Infection with unknown ANC: Lung (pneumonia)
|
2.3%
1/44 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Insomnia
|
6.8%
3/44 • Number of events 3
|
7.0%
3/43 • Number of events 3
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
56.8%
25/44 • Number of events 40
|
86.0%
37/43 • Number of events 85
|
|
Reproductive system and breast disorders
Libido
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
54.5%
24/44 • Number of events 35
|
55.8%
24/43 • Number of events 64
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
15.9%
7/44 • Number of events 8
|
14.0%
6/43 • Number of events 6
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/44
|
4.7%
2/43 • Number of events 2
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Elevated LDH; lactate dehidrogenase)
|
0.00%
0/44
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Mood alteration: agitation
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Mood alteration: depression
|
6.8%
3/44 • Number of events 3
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::oral cavity
|
4.5%
2/44 • Number of events 2
|
4.7%
2/43 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::oral cavity
|
0.00%
0/44
|
7.0%
3/43 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
|
4.5%
2/44 • Number of events 2
|
11.6%
5/43 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Right-sided
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/44
|
4.7%
2/43 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
6.8%
3/44 • Number of events 4
|
16.3%
7/43 • Number of events 7
|
|
Nervous system disorders
Neurology - Other (decreased concentration; spatial disorientation)
|
0.00%
0/44
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Neuropathy:sensory
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
36.4%
16/44 • Number of events 23
|
62.8%
27/43 • Number of events 51
|
|
Eye disorders
Ocular/Visual-Other, color contrast changes; color vision distortion; eisodic wavy vision
|
0.00%
0/44
|
0.00%
0/43
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 lymphopenia
|
9.1%
4/44 • Number of events 4
|
11.6%
5/43 • Number of events 6
|
|
Nervous system disorders
Pain: Head/Headache
|
13.6%
6/44 • Number of events 6
|
14.0%
6/43 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain: Joint
|
2.3%
1/44 • Number of events 1
|
9.3%
4/43 • Number of events 5
|
|
General disorders
Pain: Pain NOS
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain: Throat/pharynx/larynx
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
40.9%
18/44 • Number of events 24
|
39.5%
17/43 • Number of events 24
|
|
Blood and lymphatic system disorders
Platelets
|
68.2%
30/44 • Number of events 52
|
72.1%
31/43 • Number of events 54
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
6.8%
3/44 • Number of events 3
|
9.3%
4/43 • Number of events 5
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
4.5%
2/44 • Number of events 3
|
4.7%
2/43 • Number of events 2
|
|
Cardiac disorders
Prolonged QTc interval
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Proteinuria
|
4.5%
2/44 • Number of events 2
|
4.7%
2/43 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper respiratory - Other (right upper lobe cavity mass)
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
22.7%
10/44 • Number of events 11
|
4.7%
2/43 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
4.5%
2/44 • Number of events 2
|
18.6%
8/43 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
2.3%
1/44 • Number of events 1
|
4.7%
2/43 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
2.3%
1/44 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Seizure
|
18.2%
8/44 • Number of events 9
|
9.3%
4/43 • Number of events 4
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
0.00%
0/44
|
7.0%
3/43 • Number of events 3
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
15.9%
7/44 • Number of events 8
|
9.3%
4/43 • Number of events 5
|
|
Nervous system disorders
Speech impairment (e.g. dysphasia or aphasia)
|
2.3%
1/44 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
Cardiac disorders
Supraventricular & nodal arrhythmia: Sinus bradycardia
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
0.00%
0/44
|
16.3%
7/43 • Number of events 7
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Endocrine disorders
Thyroid function, high (hyperthyroidism, thyrotoxicosis)
|
2.3%
1/44 • Number of events 1
|
14.0%
6/43 • Number of events 6
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
45.5%
20/44 • Number of events 20
|
39.5%
17/43 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Weight loss
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Musculoskeletal and connective tissue disorders
Edema: head and neck
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Nervous system disorders
Memory impairment
|
4.5%
2/44 • Number of events 2
|
0.00%
0/43
|
|
Respiratory, thoracic and mediastinal disorders
Pain: chest wall
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Mucosa
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
6.8%
3/44 • Number of events 3
|
0.00%
0/43
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthia
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Eye disorders
Vision-flashing lights/floaters
|
4.5%
2/44 • Number of events 2
|
0.00%
0/43
|
|
Infections and infestations
Infection
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Renal and urinary disorders
Incontinence, urinary
|
6.8%
3/44 • Number of events 3
|
0.00%
0/43
|
|
Nervous system disorders
Dizziness
|
2.3%
1/44 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): whole body/generalized
|
0.00%
0/44
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Ataxia (incoordination)
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
4.5%
2/44 • Number of events 2
|
0.00%
0/43
|
|
Nervous system disorders
Confusion
|
6.8%
3/44 • Number of events 3
|
0.00%
0/43
|
|
Nervous system disorders
Mood alteration: anxiety
|
4.5%
2/44 • Number of events 2
|
0.00%
0/43
|
|
Nervous system disorders
Neurology Other (quadrantanopsia; sensory loss)
|
4.5%
2/44 • Number of events 2
|
0.00%
0/43
|
|
Musculoskeletal and connective tissue disorders
Pain: back
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Musculoskeletal and connective tissue disorders
Pain: neck
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Gastrointestinal disorders
Pain: oral cavity
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (hair pigmentation changes)
|
0.00%
0/44
|
2.3%
1/43 • Number of events 1
|
|
Eye disorders
Ocular/Visual - Other (color contrast changes, color vision distortion, eisodic wavy vision)
|
0.00%
0/44
|
7.0%
3/43 • Number of events 3
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
6.8%
3/44 • Number of events 3
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (high LDH)
|
2.3%
1/44 • Number of events 1
|
0.00%
0/43
|
Additional Information
Dr. Teri Kreisl
National Cancer Institute, National Institutes of Health
Phone: 301-402-3423
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place