Trial Outcomes & Findings for Bevacizumab for Recurrent Malignant Glioma (NCT NCT00271609)
NCT ID: NCT00271609
Last Updated: 2014-04-29
Results Overview
Percentage of participants surviving without progression of disease after six months of study entry. Progression is defined as a 25% increase in lesions, clear worsening of any evaluable disease, or appearance of any new lesion/site (e.g. by computed tomography, magnetic resonance imaging), or failure to return for evaluation due to death or deteriorating condition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
6 months
Results posted on
2014-04-29
Participant Flow
88 participants were accrued to this study.
Minimum washout period of 2-4 weeks required after molecularly targeted or cytotoxic agents.
Participant milestones
| Measure |
Glioblastoma Multiforme (GBM)
Glioblastoma multiforme Gliosarcoma
|
Anaplastic Glioma (AG)
Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
32
|
|
Overall Study
COMPLETED
|
43
|
29
|
|
Overall Study
NOT COMPLETED
|
13
|
3
|
Reasons for withdrawal
| Measure |
Glioblastoma Multiforme (GBM)
Glioblastoma multiforme Gliosarcoma
|
Anaplastic Glioma (AG)
Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Bevacizumab for Recurrent Malignant Glioma
Baseline characteristics by cohort
| Measure |
Anaplastic Glioma (AG)
n=32 Participants
Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
|
Glioblastoma Multiforme (GBM)
n=56 Participants
Glioblastoma multiforme Gliosarcoma
|
Total
n=88 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
|
30 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 12 • n=5 Participants
|
52.33 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
48.66 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
52 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
|
29 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
83 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
|
32 participants
n=5 Participants
|
56 participants
n=7 Participants
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: at the time of data cutoff for this endpoint, 31 patients in the AG arm and 48 patients in the GBM arm were evaluable for PFS.
Percentage of participants surviving without progression of disease after six months of study entry. Progression is defined as a 25% increase in lesions, clear worsening of any evaluable disease, or appearance of any new lesion/site (e.g. by computed tomography, magnetic resonance imaging), or failure to return for evaluation due to death or deteriorating condition.
Outcome measures
| Measure |
Anaplastic Glioma (AG)
n=31 Participants
Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
|
Glioblastoma Multiforme (GBM)
n=48 Participants
Glioblastoma multiforme Gliosarcoma
|
|---|---|---|
|
Percentage of Participants With Progression Free Survival at 6 Months.
|
20.9 Percentage of participants
Interval 10.3 to 42.5
|
29 Percentage of participants
Interval 18.0 to 48.0
|
PRIMARY outcome
Timeframe: 5 yearsHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Anaplastic Glioma (AG)
n=32 Participants
Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
|
Glioblastoma Multiforme (GBM)
n=56 Participants
Glioblastoma multiforme Gliosarcoma
|
|---|---|---|
|
Number of Participants With Adverse Events
|
32 Participants
|
51 Participants
|
Adverse Events
Anaplastic Glioma (AG)
Serious events: 11 serious events
Other events: 32 other events
Deaths: 0 deaths
Glioblastoma Multiforme (GBM)
Serious events: 24 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anaplastic Glioma (AG)
n=32 participants at risk
Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
|
Glioblastoma Multiforme (GBM)
n=56 participants at risk
Glioblastoma multiforme Gliosarcoma
|
|---|---|---|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • Number of events 1 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 3 • 5 years
|
|
Nervous system disorders
Hemorrhage, CNS
|
3.1%
1/32 • Number of events 1 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: nose
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.1%
1/32 • Number of events 1 • 5 years
|
12.5%
7/56 • Number of events 7 • 5 years
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
General disorders
Death not associated with CTCAE term: death NOS
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
General disorders
Death not associated with CTCAE term: disease progression NOS
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
General disorders
Death not associated with CTCAE term: sudden death
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 4 • 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Infections and infestations
Infection with normal ANC Grade 1 or 2 neutrophils: joint
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Infections and infestations
Infection with unknown ANC: skin (cellulitis)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Nervous system disorders
Leak, cerebrospinal fluid (CSF)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Investigations
Leukocytes (total WBC)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 2 • 5 years
|
|
Investigations
Lymphopenia
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other (specify-injury to the first index fingers & nail bed)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Necrosis, GI:gallbladder
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 lymphopenia
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Nervous system disorders
Pain:headache
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain:muscle
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain:neck
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Perforation, GI: small bowel NOS
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
9.4%
3/32 • Number of events 3 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutrophils
|
3.1%
1/32 • Number of events 2 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Lung (pneumonia)
|
3.1%
1/32 • Number of events 1 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Nervous system disorders
Seizure
|
12.5%
4/32 • Number of events 6 • 5 years
|
8.9%
5/56 • Number of events 5 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Anaplastic Glioma (AG)
n=32 participants at risk
Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
|
Glioblastoma Multiforme (GBM)
n=56 participants at risk
Glioblastoma multiforme Gliosarcoma
|
|---|---|---|
|
Vascular disorders
Hypertension
|
28.1%
9/32 • Number of events 12 • 5 years
|
19.6%
11/56 • Number of events 12 • 5 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
34.4%
11/32 • Number of events 15 • 5 years
|
19.6%
11/56 • Number of events 13 • 5 years
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
6.2%
2/32 • Number of events 2 • 5 years
|
8.9%
5/56 • Number of events 6 • 5 years
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
34.4%
11/32 • Number of events 14 • 5 years
|
32.1%
18/56 • Number of events 28 • 5 years
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
9.4%
3/32 • Number of events 6 • 5 years
|
17.9%
10/56 • Number of events 13 • 5 years
|
|
Investigations
Alkaline phosphatase
|
3.1%
1/32 • Number of events 1 • 5 years
|
10.7%
6/56 • Number of events 7 • 5 years
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/32 • 5 years
|
0.00%
0/56 • 5 years
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Nervous system disorders
Ataxia (incoordination)
|
3.1%
1/32 • Number of events 4 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Hepatobiliary disorders
Bilirubin (hyperbilirubinemia)
|
28.1%
9/32 • Number of events 12 • 5 years
|
28.6%
16/56 • Number of events 32 • 5 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
3.1%
1/32 • Number of events 1 • 5 years
|
8.9%
5/56 • Number of events 5 • 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Psychiatric disorders
Confusion
|
6.2%
2/32 • Number of events 3 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • Number of events 2 • 5 years
|
0.00%
0/56 • 5 years
|
|
General disorders
Constitutional symptoms-other (Specify-orthostasis, "dizzines" when standing x minutes, self limited
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Renal and urinary disorders
Creatinine
|
3.1%
1/32 • Number of events 9 • 5 years
|
1.8%
1/56 • Number of events 2 • 5 years
|
|
Endocrine disorders
Cushingoid appearance (e.g. moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
6.2%
2/32 • Number of events 2 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
4/32 • Number of events 4 • 5 years
|
7.1%
4/56 • Number of events 4 • 5 years
|
|
Nervous system disorders
Dizziness
|
12.5%
4/32 • Number of events 4 • 5 years
|
0.00%
0/56 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/32 • 5 years
|
0.00%
0/56 • 5 years
|
|
General disorders
Edema: limb
|
9.4%
3/32 • Number of events 4 • 5 years
|
5.4%
3/56 • Number of events 3 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
General disorders
Extremity-lower (gait/walking)
|
3.1%
1/32 • Number of events 1 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify-new urgency of bowel and bladder habits)
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
6.2%
2/32 • Number of events 3 • 5 years
|
0.00%
0/56 • 5 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
6.2%
2/32 • Number of events 2 • 5 years
|
0.00%
0/56 • 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
18.8%
6/32 • Number of events 9 • 5 years
|
17.9%
10/56 • Number of events 14 • 5 years
|
|
Renal and urinary disorders
Hemoglobinuria
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Gastrointestinal disorders
Hemorrhage, GI: Anus
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Gastrointestinal disorders
Hemorrhage, GI: Rectum
|
6.2%
2/32 • Number of events 2 • 5 years
|
0.00%
0/56 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: nose
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • Number of events 2 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC<1.0x10e9/L
|
3.1%
1/32 • Number of events 3 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: lung (pneumonia)
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection with normal ANC Grade 1 or 2 neutrophils: nerve-peripheral
|
3.1%
1/32 • Number of events 2 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: pharynx
|
6.2%
2/32 • Number of events 3 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: sinus
|
9.4%
3/32 • Number of events 3 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: skin (cellulitis)
|
6.2%
2/32 • Number of events 2 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: upper aerodigestive NOS
|
6.2%
2/32 • Number of events 2 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: upper airway NOS
|
12.5%
4/32 • Number of events 4 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: urinary tract NOS
|
12.5%
4/32 • Number of events 7 • 5 years
|
3.6%
2/56 • Number of events 3 • 5 years
|
|
Infections and infestations
Infection with unknown ANC: colon
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection with unknown ANC: pharynx
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Psychiatric disorders
Insomnia
|
6.2%
2/32 • Number of events 2 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Investigations
Lymphopenia
|
25.0%
8/32 • Number of events 19 • 5 years
|
37.5%
21/56 • Number of events 49 • 5 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
21.9%
7/32 • Number of events 8 • 5 years
|
30.4%
17/56 • Number of events 26 • 5 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
9.4%
3/32 • Number of events 4 • 5 years
|
5.4%
3/56 • Number of events 6 • 5 years
|
|
Nervous system disorders
Memory impairment
|
12.5%
4/32 • Number of events 4 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Mood alteration: depression
|
15.6%
5/32 • Number of events 5 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)L extremity-lower
|
12.5%
4/32 • Number of events 5 • 5 years
|
0.00%
0/56 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
15.6%
5/32 • Number of events 6 • 5 years
|
0.00%
0/56 • 5 years
|
|
Investigations
PTT (Partial thromboplastin Time)
|
3.1%
1/32 • Number of events 2 • 5 years
|
8.9%
5/56 • Number of events 5 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain Other (Specify-pain-extremity-limb)
|
6.2%
2/32 • Number of events 2 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Nervous system disorders
Pain: Head/headache
|
46.9%
15/32 • Number of events 25 • 5 years
|
19.6%
11/56 • Number of events 13 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain: joint
|
9.4%
3/32 • Number of events 4 • 5 years
|
5.4%
3/56 • Number of events 5 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain: muscle
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Nervous system disorders
Pain: Neuralgia/peripheral nerve
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pain: Throat/pharynx/larynx
|
3.1%
1/32 • Number of events 3 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Investigations
Pancreatic endocrine: glucose intolerance
|
3.1%
1/32 • Number of events 2 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
3.1%
1/32 • Number of events 1 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
21.9%
7/32 • Number of events 16 • 5 years
|
33.9%
19/56 • Number of events 43 • 5 years
|
|
Investigations
Platelets
|
31.2%
10/32 • Number of events 22 • 5 years
|
30.4%
17/56 • Number of events 29 • 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
15.6%
5/32 • Number of events 7 • 5 years
|
5.4%
3/56 • Number of events 4 • 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
6.2%
2/32 • Number of events 2 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
31.2%
10/32 • Number of events 27 • 5 years
|
42.9%
24/56 • Number of events 36 • 5 years
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
3.1%
1/32 • Number of events 1 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory-Other (Specify-mild dry nasal mucosa)
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
31.2%
10/32 • Number of events 12 • 5 years
|
8.9%
5/56 • Number of events 6 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.2%
2/32 • Number of events 2 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
9.4%
3/32 • Number of events 3 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: Hand/foot skin reaction
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Eye disorders
Retinopathy
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Vascular disorders
Seizure
|
15.6%
5/32 • Number of events 5 • 5 years
|
23.2%
13/56 • Number of events 20 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
3.1%
1/32 • Number of events 1 • 5 years
|
5.4%
3/56 • Number of events 4 • 5 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
21.9%
7/32 • Number of events 15 • 5 years
|
17.9%
10/56 • Number of events 17 • 5 years
|
|
Nervous system disorders
Speech impairment (e.g. dysphasia or aphasia)
|
12.5%
4/32 • Number of events 4 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: sinus bradycardia
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Nervous system disorders
Syncope (fainting)
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.1%
1/32 • Number of events 1 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Nervous system disorders
Tremor
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
12.5%
4/32 • Number of events 12 • 5 years
|
5.4%
3/56 • Number of events 6 • 5 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
3.1%
1/32 • Number of events 1 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Investigations
Weight gain
|
3.1%
1/32 • Number of events 1 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
3.1%
1/32 • Number of events 1 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32 • Number of events 3 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Bronchus
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify-psoriasis)
|
6.2%
2/32 • Number of events 2 • 5 years
|
0.00%
0/56 • 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
3.1%
1/32 • Number of events 1 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam): oral cavity
|
3.1%
1/32 • Number of events 1 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Nervous system disorders
Neuropathy: Cranial-CN II vision
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
3.1%
1/32 • Number of events 1 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin-Other (Specify-tinea, requiring med. intervention)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
0.00%
0/32 • 5 years
|
0.00%
0/56 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Extremity-upper (function)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Eye disorders
Eyelid dysfunction
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Incontinence, anal
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.00%
0/32 • 5 years
|
8.9%
5/56 • Number of events 5 • 5 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic): anus
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Nervous system disorders
Neurology-Other (Specify-visual field cut)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Nervous system disorders
Neurology: motor
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
General disorders
Pain: Other
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain : Back
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Cardiac disorders
Prolonged QTc Interval
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: atrial fibrillation
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Vascular disorders
Voice changes/dysarthria (e.g. hoarseness, loss or alteration in voice, laryngitis)
|
0.00%
0/32 • 5 years
|
7.1%
4/56 • Number of events 4 • 5 years
|
|
Nervous system disorders
Neurology-Other (Specify-worsening L-sided Parethesia, now clumsiness/?BCNU-related)
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
General disorders
Rigors/Chills
|
0.00%
0/32 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: wound
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 3 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Bladder (urinary)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 2 • 5 years
|
|
Investigations
Leukocytes (total WBC)
|
0.00%
0/32 • 5 years
|
14.3%
8/56 • Number of events 13 • 5 years
|
|
General disorders
Fever ( in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
|
3.1%
1/32 • Number of events 1 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: oral cavity-gums (gingivitis)
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Gastrointestinal disorders
Pain: oral cavity
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
General disorders
Rigors/chills
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/32 • 5 years
|
5.4%
3/56 • Number of events 3 • 5 years
|
|
Investigations
Bicarbonate, serum low
|
0.00%
0/32 • 5 years
|
5.4%
3/56 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Hemorrhage, GU: urinary NOS
|
0.00%
0/32 • 5 years
|
7.1%
4/56 • Number of events 8 • 5 years
|
|
Infections and infestations
Infection-Other (Specify- fungal infection with normal ANC)
|
0.00%
0/32 • 5 years
|
7.1%
4/56 • Number of events 4 • 5 years
|
|
Infections and infestations
Infection with unknown ANC: Upper airway NOS
|
3.1%
1/32 • Number of events 1 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Infections and infestations
Infection with unknown ANC: Urinary tract NOS
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Mood alteration: Anxiety
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): extreme-lower
|
0.00%
0/32 • 5 years
|
5.4%
3/56 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): left-sided
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): right-sided
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/32 • 5 years
|
5.4%
3/56 • Number of events 6 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain: neck
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/32 • 5 years
|
3.6%
2/56 • Number of events 2 • 5 years
|
|
Investigations
Weight loss
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 2 • 5 years
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
2/32 • Number of events 2 • 5 years
|
5.4%
3/56 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Blood and lymphatic system disorders
Hemorrhage, Central nervous system (CNS)
|
3.1%
1/32 • Number of events 1 • 5 years
|
0.00%
0/56 • 5 years
|
|
Nervous system disorders
Neuropathy-motor
|
0.00%
0/32 • 5 years
|
1.8%
1/56 • Number of events 1 • 5 years
|
Additional Information
Teri Kreisl, M.D.
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