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Details

Stereochemistry ACHIRAL
Molecular Formula C6H6N6O2
Molecular Weight 194.1508
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of TEMOZOLOMIDE

SMILES

CN1N=NC2=C(N=CN2C1=O)C(N)=O

InChI

InChIKey=BPEGJWRSRHCHSN-UHFFFAOYSA-N
InChI=1S/C6H6N6O2/c1-11-6(14)12-2-8-3(4(7)13)5(12)9-10-11/h2H,1H3,(H2,7,13)

HIDE SMILES / InChI

Description
Curator's Comment: description was created based on several sources, including https://www.google.com/patents/WO2012027693A3 | https://www.ncbi.nlm.nih.gov/pubmed/24994771

NEO 212 is novel DNA alkylating agent exhibiting superior activity against breast cancer cells in vitro and intracranial triple-negative tumor growth in vivo. NEO212 is a conjugate of temozolomide (TMZ,) with the natural product perillyl alcohol (POH). NEO 212 causes DNA damage and cell death much more efficiently than TMZ because linkage with POH increased it's biological half-life and thus provided greater opportunity for placement of cytotoxic DNA lesions.

CNS Activity

CNS Active
3913
Curator's Comment: TMZ (TEMOZOLOMIDE) is 100% bioavailable when taken orally and, because of its small size and lipophilic properties, it is able to cross the blood-brain barrier. Concentrations in the central nervous system are approximately 30% of plasma concentrations. Once it has entered the central nervous system, TMZ can be spontaneously converted to the active metabolite. These pharmacologic properties make it an ideal agent for treating central nervous system malignancies.

Originator

Neonc Technologies
2
Curator's Comment: The story of temozolomide starts in the late 1970s in Birmingham, where Professor Stevens was leading a team of researchers at Aston University.

Approval Year

1999
174
Targets

Targets

Primary TargetPharmacologyConditionPotency
Crosslinking Agent
81
DNA
278
Target ID: CHEMBL2311221
Blocker
537
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8429
TEMODAR

Approved Use

Newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and then as maintenance treatment; Refractory anaplastic astrocytoma, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine

Launch Date

1999
Primary
Approved
8429
TEMODAR

Approved Use

Newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and then as maintenance treatment; Refractory anaplastic astrocytoma, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine

Launch Date

1999
Primary
Basic research
Unknown

Approved Use

Unknown
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
7.5 μg/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf
150 mg/m² single, oral
dose: 150 mg/m²
route of administration: Oral
experiment type: SINGLE
co-administered:
TEMOZOLOMIDE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
23.4 μg × h/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf
150 mg/m² single, oral
dose: 150 mg/m²
route of administration: Oral
experiment type: SINGLE
co-administered:
TEMOZOLOMIDE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
1.8 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf
150 mg/m² single, oral
dose: 150 mg/m²
route of administration: Oral
experiment type: SINGLE
co-administered:
TEMOZOLOMIDE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
1.87 h
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT02343081
200 mg/m^2 single, oral
dose: 200 mg/m^2
route of administration: oral
experiment type: single
co-administered:
TEMOZOLOMIDE plasma
Homo sapiens
1.89 h
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT02343081
200 mg/m^2 single, oral
dose: 200 mg/m^2
route of administration: oral
experiment type: single
co-administered:
TEMOZOLOMIDE plasma
Homo sapiens
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
85%
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf
150 mg/m² single, oral
dose: 150 mg/m²
route of administration: Oral
experiment type: SINGLE
co-administered:
TEMOZOLOMIDE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
1000 mg/m2 1 times / 4 weeks multiple, oral
Highest studied dose
Dose: 1000 mg/m2, 1 times / 4 weeks
Route: oral
Route: multiple
Dose: 1000 mg/m2, 1 times / 4 weeks
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
unhealthy, adult
n = 6
Health Status: unhealthy
Condition: solid tumors
Age Group: adult
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
Other AEs: Neutropenia, Thrombocytopenia...
Other AEs:
Neutropenia (grade 4, 2 patients)
Thrombocytopenia (grade 4, 1 patient)
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
250 mg/m2 1 times / day multiple, oral
Highest studied dose
Dose: 250 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 250 mg/m2, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
unhealthy, adult
n = 3
Health Status: unhealthy
Condition: malignancies, refractory or relapsing
Age Group: adult
Population Size: 3
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
DLT: Thrombocytopenia...
Other AEs: Anaemia, Neutropenia...
Dose limiting toxicities:
Thrombocytopenia (grade 4, 2 patients)
Other AEs:
Anaemia (grade 3, 1 patient)
Neutropenia (grade 3, 2 patients)
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
200 mg/m2 1 times / day multiple, oral
MTD
Dose: 200 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg/m2, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
unhealthy, adult
n = 6
Health Status: unhealthy
Condition: malignancies, refractory or relapsing
Age Group: adult
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
Other AEs: Anaemia...
Other AEs:
Anaemia (grade 4, 1 patient)
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
750 mg/m2 1 times / 4 weeks multiple, oral
MTD
Dose: 750 mg/m2, 1 times / 4 weeks
Route: oral
Route: multiple
Dose: 750 mg/m2, 1 times / 4 weeks
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
unhealthy, adult
n = 6
Health Status: unhealthy
Condition: solid tumors
Age Group: adult
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
Other AEs: Neutropenia, Thrombocytopenia...
Other AEs:
Neutropenia (grade 4, 1 patient)
Thrombocytopenia (grade 3, 2 patients)
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Other AEs: Anorexia, Dizziness...
Other AEs:
Anorexia (all grades, 27%)
Dizziness (all grades, 5%)
Fatigue (all grades, 61%)
Headache (all grades, 23%)
Weakness (all grades, 7%)
Confusion (all grades, 5%)
Convulsions (all grades, 11%)
Memory impairment (all grades, 7%)
Vision blurred (all grades, 8%)
Allergic reaction (all grades, 3%)
Abdominal pain (all grades, 5%)
Constipation (all grades, 22%)
Diarrhea (all grades, 10%)
Nausea (all grades, 49%)
Stomatitis (all grades, 9%)
Vomiting (all grades, 29%)
Radiation injury NOS (all grades, 2%)
Arthralgia (all grades, 6%)
Thrombocytopenia (all grades, 8%)
Insomnia (all grades, 4%)
Coughing (all grades, 8%)
Dyspnea (all grades, 5%)
Alopecia (all grades, 55%)
Dry skin (all grades, 5%)
Erythema (all grades, 1%)
Pruritus (all grades, 5%)
Rash (all grades, 13%)
Taste perversion (all grades, 5%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Other AEs: Headache, Fatigue...
Other AEs:
Headache (all grades, 41%)
Fatigue (all grades, 34%)
Asthenia (all grades, 13%)
Fever (all grades, 13%)
Back pain (all grades, 8%)
Edema peripheral (all grades, 11%)
Convulsions (all grades, 23%)
Hemiparesis (all grades, 18%)
Dizziness (all grades, 12%)
Coordination abnormal (all grades, 11%)
Amnesia (all grades, 10%)
Insomnia (all grades, 10%)
Paresthesia (all grades, 9%)
Somnolence (all grades, 9%)
Paresis (all grades, 8%)
Urinary incontinence (all grades, 8%)
Ataxia (all grades, 8%)
Dysphasia (all grades, 7%)
Convulsions local (all grades, 6%)
Abnormal gait (all grades, 6%)
Confusion (all grades, 5%)
Adrenal hypercorticism (all grades, 8%)
Nausea (all grades, 53%)
Vomiting (all grades, 42%)
Constipation (all grades, 33%)
Diarrhea (all grades, 16%)
Abdominal pain (all grades, 9%)
Anorexia (all grades, 9%)
Weight increase (all grades, 5%)
Myalgia (all grades, 5%)
Anxiety (all grades, 7%)
Depression (all grades, 6%)
Breast pain female (all grades, 6%)
Infection viral (all grades, 11%)
Upper respiratory tract infection (all grades, 8%)
Pharyngitis (all grades, 8%)
Sinusitis (all grades, 6%)
Coughing (all grades, 5%)
Rash (all grades, 8%)
Pruritus (all grades, 8%)
Urinary tract infection (all grades, 8%)
Micturition frequency increased (all grades, 6%)
Diplopia (all grades, 5%)
Abnormal vision (all grades, 5%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Other AEs: Anorexia, Dizziness...
Other AEs:
Anorexia (all grades, 19%)
Dizziness (all grades, 4%)
Fatigue (all grades, 54%)
Headache (all grades, 19%)
Weakness (all grades, 3%)
Confusion (all grades, 4%)
Convulsions (all grades, 6%)
Memory impairment (all grades, 3%)
Vision blurred (all grades, 9%)
Allergic reaction (all grades, 5%)
Abdominal pain (all grades, 2%)
Constipation (all grades, 18%)
Diarrhea (all grades, 6%)
Nausea (all grades, 36%)
Stomatitis (all grades, 7%)
Vomiting (all grades, 20%)
Radiation injury NOS (all grades, 7%)
Arthralgia (all grades, 2%)
Thrombocytopenia (all grades, 4%)
Insomnia (all grades, 5%)
Coughing (all grades, 5%)
Dyspnea (all grades, 4%)
Alopecia (all grades, 69%)
Dry skin (all grades, 2%)
Erythema (all grades, 5%)
Pruritus (all grades, 4%)
Rash (all grades, 19%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
AEs

AEs

AESignificanceDosePopulation
Thrombocytopenia grade 4, 1 patient
1000 mg/m2 1 times / 4 weeks multiple, oral
Highest studied dose
Dose: 1000 mg/m2, 1 times / 4 weeks
Route: oral
Route: multiple
Dose: 1000 mg/m2, 1 times / 4 weeks
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
unhealthy, adult
n = 6
Health Status: unhealthy
Condition: solid tumors
Age Group: adult
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
Neutropenia grade 4, 2 patients
1000 mg/m2 1 times / 4 weeks multiple, oral
Highest studied dose
Dose: 1000 mg/m2, 1 times / 4 weeks
Route: oral
Route: multiple
Dose: 1000 mg/m2, 1 times / 4 weeks
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
unhealthy, adult
n = 6
Health Status: unhealthy
Condition: solid tumors
Age Group: adult
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
Anaemia grade 3, 1 patient
250 mg/m2 1 times / day multiple, oral
Highest studied dose
Dose: 250 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 250 mg/m2, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
unhealthy, adult
n = 3
Health Status: unhealthy
Condition: malignancies, refractory or relapsing
Age Group: adult
Population Size: 3
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
Neutropenia grade 3, 2 patients
250 mg/m2 1 times / day multiple, oral
Highest studied dose
Dose: 250 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 250 mg/m2, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
unhealthy, adult
n = 3
Health Status: unhealthy
Condition: malignancies, refractory or relapsing
Age Group: adult
Population Size: 3
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
Thrombocytopenia grade 4, 2 patients
DLT
250 mg/m2 1 times / day multiple, oral
Highest studied dose
Dose: 250 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 250 mg/m2, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
unhealthy, adult
n = 3
Health Status: unhealthy
Condition: malignancies, refractory or relapsing
Age Group: adult
Population Size: 3
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
Anaemia grade 4, 1 patient
200 mg/m2 1 times / day multiple, oral
MTD
Dose: 200 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg/m2, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
unhealthy, adult
n = 6
Health Status: unhealthy
Condition: malignancies, refractory or relapsing
Age Group: adult
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/10576660/
Thrombocytopenia grade 3, 2 patients
750 mg/m2 1 times / 4 weeks multiple, oral
MTD
Dose: 750 mg/m2, 1 times / 4 weeks
Route: oral
Route: multiple
Dose: 750 mg/m2, 1 times / 4 weeks
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
unhealthy, adult
n = 6
Health Status: unhealthy
Condition: solid tumors
Age Group: adult
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
Neutropenia grade 4, 1 patient
750 mg/m2 1 times / 4 weeks multiple, oral
MTD
Dose: 750 mg/m2, 1 times / 4 weeks
Route: oral
Route: multiple
Dose: 750 mg/m2, 1 times / 4 weeks
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
unhealthy, adult
n = 6
Health Status: unhealthy
Condition: solid tumors
Age Group: adult
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/14740784/
Erythema all grades, 1%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Diarrhea all grades, 10%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Convulsions all grades, 11%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Rash all grades, 13%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Radiation injury NOS all grades, 2%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Constipation all grades, 22%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Headache all grades, 23%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Anorexia all grades, 27%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Vomiting all grades, 29%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Allergic reaction all grades, 3%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Insomnia all grades, 4%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Nausea all grades, 49%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Abdominal pain all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Confusion all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Dizziness all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Dry skin all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Dyspnea all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Pruritus all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Taste perversion all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Alopecia all grades, 55%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Arthralgia all grades, 6%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Fatigue all grades, 61%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Memory impairment all grades, 7%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Weakness all grades, 7%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Coughing all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Thrombocytopenia all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Vision blurred all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Stomatitis all grades, 9%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 224
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 224
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Amnesia all grades, 10%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Insomnia all grades, 10%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Coordination abnormal all grades, 11%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Edema peripheral all grades, 11%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Infection viral all grades, 11%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Dizziness all grades, 12%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Asthenia all grades, 13%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Fever all grades, 13%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Diarrhea all grades, 16%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Hemiparesis all grades, 18%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Convulsions all grades, 23%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Constipation all grades, 33%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Fatigue all grades, 34%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Headache all grades, 41%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Vomiting all grades, 42%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Abnormal vision all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Confusion all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Coughing all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Diplopia all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Myalgia all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Weight increase all grades, 5%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Nausea all grades, 53%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Abnormal gait all grades, 6%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Breast pain female all grades, 6%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Convulsions local all grades, 6%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Depression all grades, 6%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Micturition frequency increased all grades, 6%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Sinusitis all grades, 6%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Anxiety all grades, 7%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Dysphasia all grades, 7%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Adrenal hypercorticism all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Ataxia all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Back pain all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Paresis all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Pharyngitis all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Pruritus all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Rash all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Upper respiratory tract infection all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Urinary incontinence all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Urinary tract infection all grades, 8%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Abdominal pain all grades, 9%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Anorexia all grades, 9%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Paresthesia all grades, 9%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Somnolence all grades, 9%
150 mg/m2 1 times / day multiple, oral
Recommended
Dose: 150 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 158
Health Status: unhealthy
Condition: anaplastic astrocytoma
Age Group: adult
Population Size: 158
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Constipation all grades, 18%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Anorexia all grades, 19%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Headache all grades, 19%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Rash all grades, 19%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Abdominal pain all grades, 2%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Arthralgia all grades, 2%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Dry skin all grades, 2%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Vomiting all grades, 20%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Memory impairment all grades, 3%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Weakness all grades, 3%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Nausea all grades, 36%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Confusion all grades, 4%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Dizziness all grades, 4%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Dyspnea all grades, 4%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Pruritus all grades, 4%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Thrombocytopenia all grades, 4%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Allergic reaction all grades, 5%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Coughing all grades, 5%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Erythema all grades, 5%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Insomnia all grades, 5%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Fatigue all grades, 54%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Convulsions all grades, 6%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Diarrhea all grades, 6%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Alopecia all grades, 69%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Radiation injury NOS all grades, 7%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Stomatitis all grades, 7%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Vision blurred all grades, 9%
75 mg/m2 1 times / day multiple, oral
Recommended
Dose: 75 mg/m2, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg/m2, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
unhealthy, adult
n = 288
Health Status: unhealthy
Condition: glioblastoma multiforme, newly diagnosed
Age Group: adult
Population Size: 288
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Sourcing

Sourcing

Vendor/AggregatorIDURL
ChEBI
CHEBI:72564
https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:72564
ChemicalBook
CB2708199
https://www.chemicalbook.com/ChemicalProductProperty_EN_CB2708199
MolPort
MolPort-003-850-406
https://www.molport.com/shop/molecule-link/MolPort-003-850-406
Selleck Chemicals
Methazolastone
http://www.selleckchem.com/products/Methazolastone.html
ZINC
ZINC000001482184
http://zinc15.docking.org/substances/ZINC000001482184
eMolecules
745657
https://www.emolecules.com/cgi-bin/more?vid=745657
PubMed

PubMed

TitleDatePubMed
Temozolomide in malignant gliomas.
2000 Jun
New approaches for temozolomide therapy: use in newly diagnosed glioma.
2001 Aug
Chemotherapy for the treatment of oligodendroglial tumors.
2001 Aug
Temozolomide for recurrent high-grade glioma.
2001 Aug
Treatment of brain metastases of malignant melanoma with temozolomide.
2001 Aug 23
Low-grade gliomas.
2001 Dec
Role of cytochrome P450 isoenzymes in metabolism of O(6)-benzylguanine: implications for dacarbazine activation.
2001 Dec
Multicenter phase II trial of temozolomide in patients with glioblastoma multiforme at first relapse.
2001 Feb
Phase II study of temozolomide in heavily pretreated cancer patients with brain metastases.
2001 Feb
Controversies in the management of brain metastases: the role of chemotherapy.
2001 Jan-Mar
Pharmacodynamic-mediated reduction of temozolomide tumor concentrations by the angiogenesis inhibitor TNP-470.
2001 Jul 15
Heterogeneous methylation of the O(6)-methylguanine-DNA methyltransferase promoter in immortalized IMR90 cell lines.
2001 Jun
Atypical teratoid/rhabdoid tumors in adult patients: case report and review of the literature.
2001 Mar
Death receptor-independent cytochrome c release and caspase activation mediate thymidine kinase plus ganciclovir-mediated cytotoxicity in LN-18 and LN-229 human malignant glioma cells.
2001 Mar
Design of a chimeric 3-methyl-1,2,3-triazene with mixed receptor tyrosine kinase and DNA damaging properties: a novel tumor targeting strategy.
2001 Mar
p53 effects both the duration of G2/M arrest and the fate of temozolomide-treated human glioblastoma cells.
2001 Mar 1
Combined effects of adenovirus-mediated wild-type p53 transduction, temozolomide and poly (ADP-ribose) polymerase inhibitor in mismatch repair deficient and non-proliferating tumor cells.
2001 May
Safety and efficacy of temozolomide in patients with recurrent anaplastic oligodendrogliomas after standard radiotherapy and chemotherapy.
2001 May 1
Methoxyamine potentiates DNA single strand breaks and double strand breaks induced by temozolomide in colon cancer cells.
2001 May 10
Possible efficacy of temozolomide in a patient with gliomatosis cerebri.
2001 Nov 27
New perspectives for the diagnosis and treatment of oligodendroglioma.
2001 Oct
Current and future developments in the use of temozolomide for the treatment of brain tumours.
2001 Sep
A phase II EORTC study of temozolomide in patients with malignant pleural mesothelioma.
2002 Apr
Photodynamic therapy of DNA mismatch repair-deficient and -proficient tumour cells.
2002 Apr 8
A rapid and systematic review of the effectiveness of temozolomide for the treatment of recurrent malignant glioma.
2002 Feb 12
Combined radiotherapy and temozolomide in patients with recurrent high grade glioma.
2002 Jan-Feb
Temozolomide-induced flare in high-grade gliomas: a new clinical entity.
2002 Jul
Promising survival and concomitant radiation plus temozolomide followed by adjuvant temozolomide.
2002 Jul 15
Chemotherapy-induced O(6)-benzylguanine-resistant alkyltransferase mutations in mismatch-deficient colon cancer.
2002 Jun 1
Phase II trial of temozolomide plus the matrix metalloproteinase inhibitor, marimastat, in recurrent and progressive glioblastoma multiforme.
2002 Mar 1
Promising survival for patients with newly diagnosed glioblastoma multiforme treated with concomitant radiation plus temozolomide followed by adjuvant temozolomide.
2002 Mar 1
Temozolomide as second-line chemotherapy for relapsed gliomas.
2002 May
First-line therapy with temozolomide induces regression of primary CNS lymphoma.
2002 May 28
A novel drug conjugate, NEO212, targeting proneural and mesenchymal subtypes of patient-derived glioma cancer stem cells.
2016 Feb 28
Patents

Patents

07087751
3
07446209
3
JP2004534046A
7
JP2007169300A
2
JP2009526755A
447
JP2011525180A
180
JP4054057B2
2
JP4701159B2
70
JP4851943B2
41
WO2012027693
2

Sample Use Guides

In Vivo Use Guide
Curator's Comment: Dosage of TEMODAR must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neutrophil and platelet counts at the time of initiating the next cycle. For TEMODAR dosage calculations based on body surface area (BSA). Is used: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg capsules and 100 mg powder for injection
intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Bioequivalence has been established only when TEMODAR for Injection was given over 90 minutes.
Route of Administration: Intravenous
In Vitro Use Guide
Grade IV glioma cell lines SHG44 and U251 cells were treated with 100 µmol/LT EMOZOLOMIDE (TMZ)
Name Type Language
TEMOZOLOMIDE
EMA EPAR   INN   JAN   MART.   MI   ORANGE BOOK   USAN   USP-RS   VANDF   WHO-DD  
INN   USAN  
Official Name English
temozolomide [INN]
Common Name English
MK-7365
Common Name English
NSC-362856
Code English
TEMOZOLOMIDE [EMA EPAR]
Common Name English
CCRG-81045
Code English
M&B-39831
Code English
M-39831
Code English
TEMOZOLOMIDE [EP MONOGRAPH]
Common Name English
METHAZOLASTONE
Common Name English
SCH 52365
Code English
TEMOZOLOMIDE [JAN]
Common Name English
TEMOZOLOMIDE [USAN]
Common Name English
TEMOZOLOMIDE [ORANGE BOOK]
Common Name English
SCH-52365
Code English
3,4-Dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide
Common Name English
TEMOZOLOMIDE [USP MONOGRAPH]
Common Name English
IMIDAZO(5,1-D)-1,2,3,5-TETRAZINE-8-CARBOXAMIDE, 3,4-DIHYDRO-3-METHYL-4-OXO-
Systematic Name English
TEMOZOLOMIDE [USP-RS]
Common Name English
TEMOZOLOMIDE [MART.]
Common Name English
TEMODAL
Brand Name English
TEMOZOLOMIDE [MI]
Common Name English
Temozolomide [WHO-DD]
Common Name English
M&B 39831
Code English
TEMODAR
Brand Name English
TEMOZOLOMIDE [VANDF]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C902
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
NDF-RT N0000175558
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
WHO-ATC L01AX03
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
NDF-RT N0000000236
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
FDA ORPHAN DRUG 116798
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
EMA ASSESSMENT REPORTS TEMOZOLOMIDE SUN (AUTHORIZED: GLIOMA, GLIOBLASTOMA)
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
FDA ORPHAN DRUG 895222
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
EMA ASSESSMENT REPORTS TEMOZOLOMIDE TEVA (AUTHORIZED: GLIOMA, GLIOBLASTOMA)
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
EMA ASSESSMENT REPORTS TEMOZOLOMIDE SANDOZ (AUTHORIZED: GLIOMA, GLIOBLASTOMA)
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
EMA ASSESSMENT REPORTS TEMOZOLOMIDE HEXAL (AUTHORIZED: GLIOMA, GLIOBLASTOMA)
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
FDA ORPHAN DRUG 193904
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
WHO-VATC QL01AX03
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
EMA ASSESSMENT REPORTS TEMOMEDAC (AUTHORIZED: GLIOMA, GLIOBLASTOMA)
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
FDA ORPHAN DRUG 453314
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
EU-Orphan Drug EU/3/16/1733
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
FDA ORPHAN DRUG 497215
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
EMA ASSESSMENT REPORTS TEMODAL (AUTHORIZED: GLIOMA, GLIOBLASTOMA)
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
FDA ORPHAN DRUG 698519
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
LIVERTOX NBK548816
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
EMA ASSESSMENT REPORTS TEMOZOLOMIDE ACCORD (AUTHORIZED: GLIOMA, GLIOBLASTOMA
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
FDA ORPHAN DRUG 117198
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
Code System Code Type Description
EPA CompTox
DTXSID5043714
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
MESH
C047246
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
RXCUI
37776
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY RxNorm
CAS
85622-93-1
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
USAN
LL-53
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
RS_ITEM_NUM
1643543
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
EVMPD
SUB10889MIG
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
ChEMBL
CHEMBL810
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
DRUG CENTRAL
2589
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
LACTMED
Temozolamide
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
FDA UNII
YF1K15M17Y
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
INN
6027
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
CHEBI
72564
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
MERCK INDEX
m10552
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY Merck Index
WIKIPEDIA
TEMOZOLOMIDE
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
PUBCHEM
5394
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
DRUG BANK
DB00853
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
SMS_ID
100000089638
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
DAILYMED
YF1K15M17Y
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
NSC
362856
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
IUPHAR
7301
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
NCI_THESAURUS
C1244
Created by admin on Fri Dec 15 15:40:26 GMT 2023 , Edited by admin on Fri Dec 15 15:40:26 GMT 2023
PRIMARY
ACTIVE MOIETY
Structure of TEMOZOLOMIDE
METABOLITE (PARENT)
Structure of MTIC
PRODRUG (METABOLITE ACTIVE)
Structure of METHYLHYDRAZINE
NIH
NCATS
PRIVACY ACT
ACCESSIBILITY
DISCLAIMER
HHS VULNERABILITY DISCLOSURE
For language access assistance, contact the NCATS Public Information Officer
National Center for Advancing Translational Sciences (NCATS),
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