Temozolomide Alone or in Combination With Thalidomide and... | NCT00112502 | Trialant
NCT00112502
Sponsor
M.D. Anderson Cancer Center
Status
Completed
Last Update Posted
Oct 18, 2021Actual
Enrollment
178Actual
Phase
Phase 2
Conditions
Brain and Central Nervous System Tumors
Glioblastoma Multiforme
Interventions
Celecoxib
Isotretinoin
Temozolomide
Thalidomide
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00112502
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2004-0662
Secondary IDs
ID
Type
Description
Link
MDA-ID-02586
NCI-6636
MDA-2004-0662
CDR0000432954
Other Identifier
NCI
NCI-2009-00076
Registry Identifier
NCI CTRP
Brief Title
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
Official Title
A Randomized, Factorial-Design, Phase II Trial of Temozolomide Alone and in Combination With Possible Permutations of Thalidomide, Isotretinoin and/or Celecoxib as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme
Acronym
Not provided
Organization
M.D. Anderson Cancer CenterOTHER
Status Module
Record Verification Date
Sep 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2005
Primary Completion Date
Sep 2014Actual
Completion Date
Sep 2014Actual
First Submitted Date
Jun 2, 2005
First Submission Date that Met QC Criteria
Jun 2, 2005
First Posted Date
Jun 3, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 11, 2020
Results First Submitted that Met QC Criteria
Sep 21, 2021
Results First Posted Date
Oct 18, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 21, 2021
Last Update Posted Date
Oct 18, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
M.D. Anderson Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Isotretinoin may help cells that are involved in the body's immune response to work better. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which temozolomide-containing regimen is more effective in treating glioblastoma multiforme.
PURPOSE: This randomized phase II trial is studying eight different temozolomide-containing regimens to compare how well they work in treating patients who have undergone radiation therapy for glioblastoma multiforme.
Detailed Description
OBJECTIVES:
Compare the efficacy of adjuvant temozolomide (TMZ) alone or in combination with thalidomide and/or isotretinoin and/or celecoxib, in terms of 6-month progression-free survival, in patients who have undergone radiotherapy for supratentorial glioblastoma multiforme.
Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 8 treatment arms.
Arm I: Patients receive oral temozolomide once daily on days 1-7 and 15-21.
Arm II: Patients receive temozolomide as in arm I and oral thalidomide once daily on days 1-28.
Arm III: Patients receive temozolomide as in arm I and oral isotretinoin twice daily on days 1-21.
Arm IV: Patients receive temozolomide as in arm I and oral celecoxib twice daily on days 1-28.
Arm V: Patients receive temozolomide as in arm I, thalidomide as in arm II, and isotretinoin as in arm III.
Arm VI: Patients receive temozolomide as in arm I, thalidomide as in arm II, and celecoxib as in arm IV.
Arm VII: Patients receive temozolomide as in arm I, isotretinoin as in arm III, and celecoxib as in arm IV.
Arm VIII: Patients receive temozolomide as in arm I, thalidomide as in arm II, isotretinoin as in arm III, and celecoxib as in arm IV.
In all arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patient may receive additional courses of therapy at the discretion of the treating physician.
After completion of study treatment, patients are followed for at least 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
Conditions Module
Conditions
Brain and Central Nervous System Tumors
Glioblastoma Multiforme
Keywords
adult giant cell glioblastoma
adult gliosarcoma
adult glioblastoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
178Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm I: TMZ
Active Comparator
Oral Temozolomide (TMZ) 150 mg/m^2 once daily on days 1-7 and 15-21.
Drug: Temozolomide
Arm II: TMZ + Thalidomide
Experimental
Temozolomide as in arm I and oral Thalidomide (Thal) once daily on days 1-28 (starting dose 200 mg).
Drug: Temozolomide
Drug: Thalidomide
Arm III: TMZ + Isotretinoin
Experimental
Temozolomide as in Arm I and oral Isotretinoin 40 mg/m^2 twice daily on days 1-21.
Drug: Isotretinoin
Drug: Temozolomide
Arm IV: TMZ + Celecoxib
Experimental
Temozolomide as in arm I and oral Celecoxib 400 mg twice daily on days 1-28.
Drug: Celecoxib
Drug: Temozolomide
Arm V: TMZ + Thalidomide + Isotretinoin
Experimental
Temozolomide as in arm I, Thalidomide as in arm II, and Isotretinoin as in arm III.
Drug: Isotretinoin
Drug: Temozolomide
Drug: Thalidomide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Celecoxib
Drug
400 mg orally twice a day continuous dosing
Arm IV: TMZ + Celecoxib
Arm VI: TMZ + Thalidomide + Celecoxib
Arm VII: TMZ + Isotretinoin + Celecoxib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Median Progression-Free Survival (PFS) Comparison of Thalidomide Arms Versus no Thalidomide Arms
Thalidomide versus not Thalidomide analysis: Comparison of median PFS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up, up to one year (12 study cycles).
Median Progression-Free Survival (PFS) Comparison of Celecoxib Arms Versus no Celecoxib Arms
Celecoxib versus not Celecoxib analysis: We compared the median PFS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Median Progression-Free Survival (PFS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms
Isotretinoin versus not Isotretinoin analysis: We compared the median PFS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Secondary Outcomes
Measure
Description
Time Frame
Median Progression-Free Survival (PFS) Comparison of Doublet Versus Triplet Therapy
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median PFS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Must have undergone a biopsy OR subtotal or gross total resection of the tumor
Must have completed post-operative (or post-biopsy) radiotherapy within the past 5 weeks
No progressive disease after radiotherapy
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Karnofsky 60-100%
Life expectancy
Not specified
Hematopoietic
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hepatic
Serum glutamate pyruvate transaminase (SGPT) < 2 times upper limit of normal (ULN)
Alkaline phosphatase < 2 times ULN
Bilirubin ≤ 1.5 mg/dL
Renal
blood urea nitrogen (BUN) ≤ 1.5 times ULN
Creatinine ≤ 1.5 times ULN
Immunologic
No history of allergic reactions attributed to compounds of similar chemical or biological composition to celecoxib or to sulfonamides
No asthma, urticaria, or allergic reactions to aspirin or other NSAIDs
No active infection
Gastrointestinal
No inflammatory bowel disease
No history of peptic ulcer disease
No gastrointestinal bleeding within past 3 months
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double-method contraception during and for 2 months after study participation
Fertile female patients randomized to receive thalidomide must use effective double-method contraception for ≥ 4 weeks before, during, and ≥ 4 weeks after completion of study therapy
Fertile male patients randomized to receive thalidomide must use effective contraception during and for ≥ 4 weeks after completion of study therapy
No blood donation (for patients randomized to receive thalidomide)
No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix or cancer that is in complete remission and patient completed all therapy for that disease ≥ 3 years ago
No other disease that would obscure toxicity or dangerously alter drug metabolism (e.g., severe connective tissue disease)
No other serious medical illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Prior temozolomide in combination with radiotherapy allowed
No other prior or concurrent chemotherapy
Endocrine therapy
Not specified
Radiotherapy
See Disease Characteristics
See Chemotherapy
Surgery
See Disease Characteristics
No concurrent surgery
Other
No other concurrent non-steroidal anti-inflammatory drugs (NSAIDs) (for patients randomized to receive celecoxib)
No other concurrent investigational drugs
No other concurrent anticancer therapy
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Marta Penas-Prado, MD
M.D. Anderson Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Gilbert MR, Gonzalez J, Hunter K, Hess K, Giglio P, Chang E, Puduvalli V, Groves MD, Colman H, Conrad C, Levin V, Woo S, Mahajan A, de Groot J, Yung WK. A phase I factorial design study of dose-dense temozolomide alone and in combination with thalidomide, isotretinoin, and/or celecoxib as postchemoradiation adjuvant therapy for newly diagnosed glioblastoma. Neuro Oncol. 2010 Nov;12(11):1167-72. doi: 10.1093/neuonc/noq100. Epub 2010 Aug 20.
Recruitment Period: September 2005 to February 2011 from various hospitals and institutions representing the Community Clinical Oncology Program (CCOP). A total of 146 participants were accrued at MD Anderson Cancer Center and 32 at the remaining participating sites.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm I: TMZ
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
FG001
Arm II: TMZ + Thalidomide
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Arm VI: TMZ + Thalidomide + Celecoxib
Experimental
Temozolomide as in Arm I, Thalidomide as in Arm II, and Celecoxib as in Arm IV.
Drug: Celecoxib
Drug: Temozolomide
Drug: Thalidomide
Arm VII: TMZ + Isotretinoin + Celecoxib
Experimental
Temozolomide as in Arm I, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
Drug: Celecoxib
Drug: Isotretinoin
Drug: Temozolomide
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Experimental
Temozolomide as in Arm I, Thalidomide as in Arm II, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
Drug: Celecoxib
Drug: Isotretinoin
Drug: Temozolomide
Drug: Thalidomide
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Celebrex
Isotretinoin
Drug
40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Arm III: TMZ + Isotretinoin
Arm V: TMZ + Thalidomide + Isotretinoin
Arm VII: TMZ + Isotretinoin + Celecoxib
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Accutane
13-Cis-Retinoic Acid
Temozolomide
Drug
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Arm I: TMZ
Arm II: TMZ + Thalidomide
Arm III: TMZ + Isotretinoin
Arm IV: TMZ + Celecoxib
Arm V: TMZ + Thalidomide + Isotretinoin
Arm VI: TMZ + Thalidomide + Celecoxib
Arm VII: TMZ + Isotretinoin + Celecoxib
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Temodar
Thalidomide
Drug
400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)
Arm II: TMZ + Thalidomide
Arm V: TMZ + Thalidomide + Isotretinoin
Arm VI: TMZ + Thalidomide + Celecoxib
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Thalomid
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Median Progression-Free Survival (PFS) of Individual Arms
Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Median Overall Survival (OS) Comparison of Thalidomide Arms Versus no Thalidomide Arms
Thalidomide versus not Thalidomide analysis: We compared the median OS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Every 3 months from randomization until progression of disease, death or last follow-up.
Median Overall Survival (OS) Comparison of Celecoxib Arms Versus no Celecoxib Arms
Celecoxib versus not Celecoxib analysis: We compared the median OS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Every 3 months from randomization until progression of disease, death or last follow-up.
Median Overall Survival (OS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms
Isotretinoin versus not Isotretinoin analysis: We compared the median OS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Every 3 months from randomization until progression of disease, death or last follow-up.
Median Overall Survival (OS) Comparison of Doublet Versus Triplet Therapy
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median OS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Every 3 months from randomization until progression of disease, death or last follow-up.
Overall Survival of Individual Arms
Overall Survival (OS) was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Every 3 months from randomization until progression of disease, death or last follow-up.
University of Texas MD Anderson Cancer Center at Orlando
Orlando
Florida
32806-2134
United States
CCOP - Atlanta Regional
Atlanta
Georgia
30342-1701
United States
CCOP - Central Illinois
Decatur
Illinois
62526
United States
CCOP - Wichita
Wichita
Kansas
67214-3882
United States
CCOP - Grand Rapids
Grand Rapids
Michigan
49503
United States
CCOP - Kalamazoo
Kalamazoo
Michigan
49007-3731
United States
CCOP - Kansas City
Kansas City
Missouri
64131
United States
Cancer Research for the Ozarks
Springfield
Missouri
65804
United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus
Ohio
43210-1240
United States
CCOP - Upstate Carolina
Spartanburg
South Carolina
29303
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030-4009
United States
Derived
Penas-Prado M, Hess KR, Fisch MJ, Lagrone LW, Groves MD, Levin VA, De Groot JF, Puduvalli VK, Colman H, Volas-Redd G, Giglio P, Conrad CA, Salacz ME, Floyd JD, Loghin ME, Hsu SH, Gonzalez J, Chang EL, Woo SY, Mahajan A, Aldape KD, Yung WK, Gilbert MR; MD Anderson Community Clinical Oncology Program; Brain Tumor Trials Collaborative. Randomized phase II adjuvant factorial study of dose-dense temozolomide alone and in combination with isotretinoin, celecoxib, and/or thalidomide for glioblastoma. Neuro Oncol. 2015 Feb;17(2):266-73. doi: 10.1093/neuonc/nou155. Epub 2014 Sep 19.
FG002
Arm III: TMZ + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
FG003
Arm IV: TMZ + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
FG004
Arm V: TMZ + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
FG005
Arm VI: TMZ + Thalidomide + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
FG006
Arm VII: TMZ + Thalidomide + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
FG007
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
FG00022 subjects
FG00122 subjects
FG00222 subjects
FG00322 subjects
FG00423 subjects
FG00522 subjects
FG00623 subjects
FG00722 subjects
COMPLETED
FG00022 subjects
FG00121 subjects
FG00221 subjects
FG00318 subjects
FG00421 subjects
FG00517 subjects
FG00620 subjects
FG00715 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0034 subjects
FG0042 subjects
FG0055 subjects
FG0063 subjects
FG0077 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0034 subjects
FG0042 subjects
FG0055 subjects
FG0063 subjects
FG0077 subjects
A 178 participants in total were randomized, out of which 23 participants were randomized but not treated because of consent withdrawal with some further difficulties obtaining insurance coverage.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm I: TMZ
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
BG001
Arm II: TMZ + Thalidomide
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
BG002
Arm III: TMZ + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
BG003
Arm IV: TMZ + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
BG004
Arm V: TMZ + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
BG005
Arm VI: TMZ + Thalidomide + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
BG006
Arm VII: TMZ + Thalidomide + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
BG007
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00022
BG00122
BG00222
BG00322
BG00423
BG00522
BG00623
BG00722
BG008178
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
<=19 years:
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG00110
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00022
BG00122
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Median Progression-Free Survival (PFS) Comparison of Thalidomide Arms Versus no Thalidomide Arms
Thalidomide versus not Thalidomide analysis: Comparison of median PFS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Posted
Median
95% Confidence Interval
months
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up, up to one year (12 study cycles).
ID
Title
Description
OG000
Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII
Arm II: TMZ + Thalidomide, Arm VI: TMZ + Thalidomide + Celecoxib, Arm VII: TMZ + Thalidomide + Isotretinoin and Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG001
No Thalidomide: Arm I, Arm III, Arm IV and Arm V
Arm I: TMZ, Arm III: TMZ + Celecoxib, Arm IV: TMZ + Isotretinoin and Arm V: TMZ + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Units
Counts
Participants
OG00070
OG00185
Title
Denominators
Categories
Title
Measurements
OG0007.6(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG0018.7(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.2
2-Sided
95
0.8
1.7
Superiority or Other (legacy)
Primary
Median Progression-Free Survival (PFS) Comparison of Celecoxib Arms Versus no Celecoxib Arms
Celecoxib versus not Celecoxib analysis: We compared the median PFS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Posted
Median
95% Confidence Interval
months
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
ID
Title
Description
OG000
Celecoxib: Arm III, Arm V, Arm VI and Arm VIII
Arm III: TMZ + Celecoxib, Arm V: TMZ + Isotretinoin + Celecoxib, Arm VI: TMZ + Thalidomide + Celecoxib and Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG001
No Celecoxib: Arm I, Arm II, Arm IV and Arm VII
Primary
Median Progression-Free Survival (PFS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms
Isotretinoin versus not Isotretinoin analysis: We compared the median PFS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Posted
Median
95% Confidence Interval
months
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
ID
Title
Description
OG000
Isotretinoin: Arm IV, Arm V, Arm VII and Arm VIII
Arm IV: TMZ + Isotretinoin, Arm V: TMZ + Isotretinoin + Celecoxib, Arm VII: TMZ + Thalidomide + Isotretinoin and Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG001
No Isotretinoin: Arm I, Arm II, Arm III and Arm VI
Secondary
Median Progression-Free Survival (PFS) Comparison of Doublet Versus Triplet Therapy
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median PFS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Posted
Median
95% Confidence Interval
months
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
ID
Title
Description
OG000
Doublet (2 Agents): Arm II, Arm III and Arm IV
Arm II: TMZ + Thalidomide, Arm III: TMZ + Celecoxib and Arm IV: TMZ + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG001
Triplet (3 Agents): Arm V, Arm VI and Arm VII
Secondary
Median Progression-Free Survival (PFS) of Individual Arms
Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Posted
Median
95% Confidence Interval
months
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
ID
Title
Description
OG000
Arm I: TMZ
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
OG001
Arm II: TMZ + Thalidomide
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
OG002
Arm III: TMZ + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Secondary
Median Overall Survival (OS) Comparison of Thalidomide Arms Versus no Thalidomide Arms
Thalidomide versus not Thalidomide analysis: We compared the median OS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Posted
Median
95% Confidence Interval
months
Every 3 months from randomization until progression of disease, death or last follow-up.
ID
Title
Description
OG000
Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII
Arm II: TMZ + Thalidomide, Arm VI: TMZ + Thalidomide + Celecoxib, Arm VII: TMZ + Thalidomide + Isotretinoin and Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG001
No Thalidomide: Arm I, Arm III, Arm IV and Arm V
Secondary
Median Overall Survival (OS) Comparison of Celecoxib Arms Versus no Celecoxib Arms
Celecoxib versus not Celecoxib analysis: We compared the median OS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Posted
Median
95% Confidence Interval
months
Every 3 months from randomization until progression of disease, death or last follow-up.
ID
Title
Description
OG000
Celecoxib: Arm III, Arm V, Arm VI and Arm VIII
Arm III: TMZ + Celecoxib, Arm V: TMZ + Isotretinoin + Celecoxib, Arm VI: TMZ + Thalidomide + Celecoxib and Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG001
No Celecoxib: Arm I, Arm II, Arm IV and Arm VII
Secondary
Median Overall Survival (OS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms
Isotretinoin versus not Isotretinoin analysis: We compared the median OS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Posted
Median
95% Confidence Interval
months
Every 3 months from randomization until progression of disease, death or last follow-up.
ID
Title
Description
OG000
Isotretinoin: Arm IV, Arm V, Arm VII and ARM VIII
Arm IV: TMZ + Isotretinoin, Arm V: TMZ + Isotretinoin + Celecoxib, Arm VII: TMZ + Thalidomide + Isotretinoin and Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG001
No Isotretinoin: Arm I, Arm II, Arm III and ARM VI
Secondary
Median Overall Survival (OS) Comparison of Doublet Versus Triplet Therapy
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median OS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Posted
Median
95% Confidence Interval
months
Every 3 months from randomization until progression of disease, death or last follow-up.
ID
Title
Description
OG000
Doublet (2 Agents): Arm II, Arm III and Arm IV
Arm II: TMZ + Thalidomide, Arm III: TMZ + Celecoxib and Arm IV: TMZ + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG001
Triplet (3 Agents): Arm V, Arm VI and Arm VII
Secondary
Overall Survival of Individual Arms
Overall Survival (OS) was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Posted
Median
95% Confidence Interval
months
Every 3 months from randomization until progression of disease, death or last follow-up.
ID
Title
Description
OG000
Arm I: TMZ
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
OG001
Arm II: TMZ + Thalidomide
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
OG002
Arm III: TMZ + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Time Frame
Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from study drug administration to time of progression, death, or last follow-up,1 year", "Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from study drug administration to time of progression, death, or last follow-up, up to 5 years.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm I: TMZ
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
11
22
22
22
EG001
Arm II: TMZ + Thalidomide
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
9
21
21
21
EG002
Arm III: TMZ + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
7
21
21
21
EG003
Arm IV: TMZ + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
8
18
18
18
EG004
Arm V: TMZ + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
12
21
21
21
EG005
Arm VI: TMZ + Thalidomide + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
15
17
17
17
EG006
Arm VII: TMZ + Thalidomide + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
8
20
20
20
EG007
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
7
15
15
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphopenia
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG00010 events10 affected22 at risk
EG0015 events5 affected21 at risk
EG0025 events5 affected21 at risk
EG0035 events5 affected18 at risk
EG00411 events11 affected21 at risk
EG00510 events10 affected17 at risk
EG0063 events3 affected20 at risk
EG0074 events4 affected15 at risk
Platelets
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Thrombosis
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Leukocytes
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Neutrophils
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0013 events3 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Pyramidal Tract Dysfunction
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Gait/Walking
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Death
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Fatigue
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Hemoglobin
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Obesity
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Pneumonia
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Sinus Bradycardia
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Pulmonary Embolism
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Erythema Multiforme
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukocytes
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG00054 events16 affected22 at risk
EG00128 events14 affected21 at risk
EG00243 events16 affected21 at risk
EG00334 events15 affected18 at risk
EG00466 events16 affected21 at risk
EG00535 events17 affected17 at risk
EG00636 events11 affected20 at risk
EG00732 events14 affected15 at risk
Lymphopenia
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG00099 events22 affected22 at risk
EG00135 events21 affected21 at risk
EG00270 events21 affected21 at risk
EG003
Neutrophils
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG00037 events13 affected22 at risk
EG00125 events11 affected21 at risk
EG00230 events9 affected21 at risk
EG003
Platelets
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG00035 events13 affected22 at risk
EG0018 events5 affected21 at risk
EG00228 events12 affected21 at risk
EG003
Fatigue
General disorders
CTCAE (3.0)
Systematic Assessment
EG00027 events19 affected22 at risk
EG00116 events13 affected21 at risk
EG00220 events16 affected21 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0008 events8 affected22 at risk
EG0015 events5 affected21 at risk
EG00210 events6 affected21 at risk
EG003
Anorexia
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0009 events8 affected22 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected21 at risk
EG003
Infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
Normal ANC or Grade 1 or 2 neutrophils
EG0001 events1 affected22 at risk
EG0013 events3 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Muscle Weakness
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG00016 events11 affected22 at risk
EG0015 events5 affected21 at risk
EG00210 events9 affected21 at risk
EG003
Syncope
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0013 events3 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Hemoglobin
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG00039 events16 affected22 at risk
EG00112 events8 affected21 at risk
EG00239 events17 affected21 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG00035 events18 affected22 at risk
EG00110 events8 affected21 at risk
EG00238 events17 affected21 at risk
EG003
Depression
Psychiatric disorders
CTCAE (3.0)
Systematic Assessment
EG0004 events3 affected22 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0004 events4 affected22 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected21 at risk
EG003
Amylase
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Hypertriglyceridemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0007 events6 affected22 at risk
EG0017 events7 affected21 at risk
EG0027 events7 affected21 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events2 affected22 at risk
EG0018 events3 affected21 at risk
EG0024 events3 affected21 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Lipase
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Pain
General disorders
CTCAE (3.0)
Systematic Assessment
Extremity-limb
EG0001 events1 affected22 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Speech Impairment
General disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0016 events6 affected21 at risk
EG0024 events4 affected21 at risk
EG003
Opportunistic Infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events3 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0004 events3 affected22 at risk
EG0011 events1 affected21 at risk
EG0024 events3 affected21 at risk
EG003
ALT, SGPT
Hepatobiliary disorders
CTCAE (3.0)
Systematic Assessment
EG0007 events6 affected22 at risk
EG0016 events5 affected21 at risk
EG00214 events8 affected21 at risk
EG003
AST, SGOT
Hepatobiliary disorders
CTCAE (3.0)
Systematic Assessment
EG0004 events4 affected22 at risk
EG0018 events5 affected21 at risk
EG00210 events9 affected21 at risk
EG003
Sinus Bradycardia
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Thrombosis
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0005 events4 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Weight Loss
General disorders
CTCAE (3.0)
Systematic Assessment
EG00011 events10 affected22 at risk
EG0011 events1 affected21 at risk
EG0025 events5 affected21 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Fever
General disorders
CTCAE (3.0)
Systematic Assessment
Absence of Neutropenia
EG0005 events4 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Headache
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG00013 events10 affected22 at risk
EG00111 events9 affected21 at risk
EG0029 events9 affected21 at risk
EG003
Constipation
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG00013 events13 affected22 at risk
EG00111 events11 affected21 at risk
EG0029 events9 affected21 at risk
EG003
Hypercholesteremia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG00012 events9 affected22 at risk
EG0016 events6 affected21 at risk
EG0023 events3 affected21 at risk
EG003
Dizziness
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0007 events7 affected22 at risk
EG0016 events6 affected21 at risk
EG00210 events9 affected21 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events3 affected22 at risk
EG0012 events2 affected21 at risk
EG0024 events4 affected21 at risk
EG003
Ataxia
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Pyramidal Tract Dysfunction
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG00010 events10 affected22 at risk
EG0015 events5 affected21 at risk
EG0027 events7 affected21 at risk
EG003
Alkaline Phosphatase
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG00014 events6 affected22 at risk
EG0012 events2 affected21 at risk
EG0024 events2 affected21 at risk
EG003
Allergic Reaction
Immune system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Allergic Rhinitis
Immune system disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events3 affected22 at risk
EG0014 events4 affected21 at risk
EG0025 events5 affected21 at risk
EG003
Rhinitis
Immune system disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Hearing Loss
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0025 events5 affected21 at risk
EG003
Left Ear Drainage
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Low Bicarbonate
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0015 events2 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Hyperbilirubinemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events2 affected22 at risk
EG0013 events3 affected21 at risk
EG0025 events3 affected21 at risk
EG003
Anemia
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0023 events2 affected21 at risk
EG003
Hematocrit
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Blurred Vision
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0006 events4 affected22 at risk
EG0011 events1 affected21 at risk
EG0024 events4 affected21 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Bruising
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Supraventricular Arrhythmia-Sinus Tachycardia
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
CO2 Serum High
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0005 events4 affected22 at risk
EG0012 events2 affected21 at risk
EG0026 events5 affected21 at risk
EG003
Cognitive Disturbance
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0007 events6 affected22 at risk
EG0014 events4 affected21 at risk
EG0027 events7 affected21 at risk
EG003
Colitis
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Confusion
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0004 events3 affected22 at risk
EG0010 events0 affected21 at risk
EG0025 events4 affected21 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG00010 events8 affected22 at risk
EG0013 events3 affected21 at risk
EG0024 events3 affected21 at risk
EG003
Creatinine
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0007 events6 affected22 at risk
EG0013 events3 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0025 events3 affected21 at risk
EG003
Xerostomia
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Dysphagia
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Edema
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
Limb
EG0004 events4 affected22 at risk
EG0012 events2 affected21 at risk
EG0026 events6 affected21 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Gait/Walking
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0005 events5 affected22 at risk
EG0015 events5 affected21 at risk
EG0028 events7 affected21 at risk
EG003
Bloating
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events3 affected22 at risk
EG0010 events0 affected21 at risk
EG0025 events5 affected21 at risk
EG003
Heartburn
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Hot Flashes
Endocrine disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hemorrhage
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected21 at risk
EG003
Hypermagnesemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hypertension
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0006 events4 affected22 at risk
EG0014 events4 affected21 at risk
EG0022 events1 affected21 at risk
EG003
Hyperuricemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0005 events5 affected22 at risk
EG0011 events1 affected21 at risk
EG0026 events5 affected21 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0013 events1 affected21 at risk
EG0027 events3 affected21 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0006 events5 affected22 at risk
EG0014 events3 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Hypotension
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Upper Respiratory Infection
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0006 events3 affected22 at risk
EG0013 events3 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Cellulitis
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Herpes
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Infection with Unknown ANC
Infections and infestations
CTCAE (3.0)
Systematic Assessment
Vagina - yeast
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Gingivitis
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Urinary Tract Infection
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Shingles
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Infection with Normal ANC
Infections and infestations
CTCAE (3.0)
Systematic Assessment
Eye
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Infection with Normal ANC
Infections and infestations
CTCAE (3.0)
Systematic Assessment
Abdomen/GI
EG0003 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Insomnia
General disorders
CTCAE (3.0)
Systematic Assessment
EG0008 events7 affected22 at risk
EG0012 events2 affected21 at risk
EG0025 events5 affected21 at risk
EG003
Involuntary Movement
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0023 events2 affected21 at risk
EG003
Libido
Reproductive system and breast disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0013 events3 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Memory Impairment
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0009 events9 affected22 at risk
EG0015 events5 affected21 at risk
EG0027 events7 affected21 at risk
EG003
High Lactate Dehydrogenase
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG00010 events8 affected22 at risk
EG0013 events3 affected21 at risk
EG0025 events4 affected21 at risk
EG003
High BUN Serum
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0009 events5 affected22 at risk
EG0012 events2 affected21 at risk
EG00213 events8 affected21 at risk
EG003
Hyperlipidemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
High Chloride Serum
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0004 events3 affected22 at risk
EG0016 events3 affected21 at risk
EG0027 events5 affected21 at risk
EG003
Hyperphosphatemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0007 events4 affected22 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected21 at risk
EG003
High Bicarbonate
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Low Chloride Serum
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Low Protein Serum
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0012 events1 affected21 at risk
EG0025 events3 affected21 at risk
EG003
High Protein Serum
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Low Uric Acid
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Anxiety
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events3 affected22 at risk
EG0011 events1 affected21 at risk
EG0023 events3 affected21 at risk
EG003
Agitation
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Paranasal Sinus Reactions
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG00014 events11 affected22 at risk
EG0017 events6 affected21 at risk
EG00211 events9 affected21 at risk
EG003
Neuropathy
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
Cranial
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Neuropathy - Motor
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Neuropathy - Sensory
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0004 events4 affected22 at risk
EG0014 events3 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Tingling
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events3 affected22 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Dysesthesias
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Numbness
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0004 events4 affected22 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected21 at risk
EG003
Unsteady Gait
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Radiculopathy
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Anopsia
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected21 at risk
EG003
Lowered Visual Acuity
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Loss of Vision
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Otitis
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Chest Pain
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0006 events5 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Ear Pain
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0005 events4 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Breast Pain
Reproductive system and breast disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0005 events5 affected22 at risk
EG0012 events2 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Joint Pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Abdomen/GI Pain
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Knee Pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Ankle Pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Shoulder Pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Jaw Pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Wrist Pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Neuralgia
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Pain
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
Suprapubic
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Photophobia
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Edema
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
Eye
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Retinopathy
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Chills
General disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Seizure
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0005 events5 affected22 at risk
EG0016 events6 affected21 at risk
EG00214 events5 affected21 at risk
EG003
Hypernatremia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0003 events2 affected22 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Somnolence
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Tremor
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0013 events3 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Tinnitus
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Taste Alteration
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Urinary Frequency
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0005 events4 affected22 at risk
EG0013 events2 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Vital Capacity
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Thrombophlebitis
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Voice Changes
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0005 events5 affected22 at risk
EG0014 events4 affected21 at risk
EG0025 events4 affected21 at risk
EG003
Watery Eye
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Weight Gain
General disorders
CTCAE (3.0)
Systematic Assessment
EG0002 events2 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Allergy
Immune system disorders
CTCAE (3.0)
Systematic Assessment
Penicillin
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Allergy
Immune system disorders
CTCAE (3.0)
Systematic Assessment
Iodine
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Dehydration
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Cushingoid
Endocrine disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Diabetes
Endocrine disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Diplopia
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Distension
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Dry Eye
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0012 events2 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Dry Mouth
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Edema
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
Head and Neck
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0023 events3 affected21 at risk
EG003
Eyelid Dysfunction
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Thrush
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events1 affected21 at risk
EG003
Mucositis
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Hiccoughs
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Oral Candidiasis
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Irregular Menses
Reproductive system and breast disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Low Phenytoin
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Muscle Cramps
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Nail Changes
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Nystagmus
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Orgasmic dyfunction
Reproductive system and breast disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Mouth Sores
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Hip Pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Renal Pain
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Proteinuria
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0023 events2 affected21 at risk
EG003
Psychosis
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Membranous Glomerulonephritis
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Thrombotic Thrombocytopenic Purpura
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Ulcer
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Vaginal Dryness
Reproductive system and breast disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Varicosities
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Mood Changes
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected21 at risk
EG003
Stress Incontinence
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Extraocular Movement
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected21 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Ascites
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Low BUN Serum
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Throat Pain
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Periodontal Disease
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Bilateral Ankle Swelling
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Facial Hair Growth
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Gastritis
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Toe Infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Sore Throat
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Infection with Normal ANC
Infections and infestations
CTCAE (3.0)
Systematic Assessment
Prostate
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Exophoria
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Esotropia
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
CN VI Palsy
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Palpitations
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hematuria
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Supraventricular Arrhythmia-Atrial Fibrillation
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hypothyroidism
Endocrine disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Erythema Multiforme
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hyperalbuminenia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Low Lactate Dehydrogenase
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0012 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Short Term Memory
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Obesity
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Astigmatism
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Conjunctival Infection
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Eye Pain
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Photosensitivity
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Dysuria
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Cheilosis
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Dysgeusia
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Dyspepsia
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Indigestion
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Diverticulitis
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Ear Wax
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Asymmetrical Optic Cup
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Creatine Phosphokinase
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Ecchymosis Lower Extremity
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Edema
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
Larynx
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Fracture
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Dystonic Meige Syndrome
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Intermittent Appetite Change
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0013 events2 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Bilateral Hands/Feet Swelling
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Left VII CN Palsy
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Disorientation
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Light Headedness
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Muscles Twitching
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Bronchitis
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Uticaria
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Tympanic Membrane Perforation
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Bladder Spasms
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Burn
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Restlessness
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Flu-Like Syndrome
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
GERD
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Polyp in the Cardia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Gilbert's Disease
Hepatobiliary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hemorrhoids
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Burning During Urination
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Gout
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hyperreflexia
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Breast Tenderness
Reproductive system and breast disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Anisocoria
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Partial Thromboplastin Time
Blood and lymphatic system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Tachycardia
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Chest Tightness
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Low Testosterone
Endocrine disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Ulceration
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
Face and Right Ear
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Wound Complication
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
Non-Infectious
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
CO2 Serum Low
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Swollen Eyes
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Cardiac Arrhythmia
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Skin Sensitivity
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Flatulence
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Flushing
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hepatic Hemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Hyperpigmentation
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Anal Incontinence
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Sarcoidosis
Immune system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Agraphesthesia
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Apraxia
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Otosclerosis
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Facial Droop
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Deep Tendon Reflexes - Limb
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
Decreased/Increased
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Necrosis
Vascular disorders
CTCAE (3.0)
Systematic Assessment
Colon/Cecum/Appendix
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Kidney Stones
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Cervical Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Peripheral Vascular Disease
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Vein Injury
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Injection Site Reaction
Skin and subcutaneous tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Left Hemiparesis
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Thyroid Problems
Endocrine disorders
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Asymptomatic Thyroid Nodule
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (3.0)
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected21 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
Yes
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Not provided
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
John F de Groot, Chair Ad Interim, Neuro-Oncology
The University of Texas (UT) MD Anderson Cancer Center
713-745-3072
jdegroot@mdanderson.org
ID
Term
D016543
Central Nervous System Neoplasms
D005909
Glioblastoma
D018316
Gliosarcoma
Ancestor Terms
ID
Term
D009423
Nervous System Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D009422
Nervous System Diseases
D001254
Astrocytoma
D005910
Glioma
D018302
Neoplasms, Neuroepithelial
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009370
Neoplasms by Histologic Type
D009375
Neoplasms, Glandular and Epithelial
D009380
Neoplasms, Nerve Tissue
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068579
Celecoxib
D015474
Isotretinoin
D000077204
Temozolomide
D013792
Thalidomide
Ancestor Terms
ID
Term
D000096926
Benzenesulfonamides
D013449
Sulfonamides
D000577
Amides
D009930
Organic Chemicals
D001555
Benzene Derivatives
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D013450
Sulfones
D013457
Sulfur Compounds
D011720
Pyrazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D012176
Retinoids
D002338
Carotenoids
D011090
Polyenes
D000475
Alkenes
D006839
Hydrocarbons, Acyclic
D053138
Cyclohexenes
D003510
Cyclohexanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D013729
Terpenes
D010860
Pigments, Biological
D001685
Biological Factors
D003606
Dacarbazine
D014226
Triazenes
D007093
Imidazoles
D010797
Phthalimides
D010795
Phthalic Acids
D000146
Acids, Carbocyclic
D002264
Carboxylic Acids
D010881
Piperidones
D010880
Piperidines
D054833
Isoindoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
Browse Leaves
Not provided
Browse Branches
Not provided
1
BG0040
BG0050
BG0060
BG0070
BG0081
Between 20 and 59 years:
Title
Measurements
BG00017
BG00112
BG00217
BG00314
BG00420
BG00518
BG00615
BG00717
BG008130
>=60 years:
Title
Measurements
BG0005
BG00110
BG0025
BG0037
BG0043
BG0054
BG0068
BG0075
BG00847
5
BG0038
BG0044
BG0056
BG0066
BG0079
BG00855
Male
BG00015
BG00112
BG00217
BG00314
BG00419
BG00516
BG00617
BG00713
BG008123
22
BG00322
BG00423
BG00522
BG00623
BG00722
BG008178
Arm I: TMZ, Arm II: TMZ + Thalidomide, Arm IV: TMZ + Isotretinoin and Arm VII: TMZ + Thalidomide + Isotretinoin.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Units
Counts
Participants
OG00074
OG00181
Title
Denominators
Categories
Title
Measurements
OG0008.3(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG0017.4(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.8
2-Sided
95
0.6
1.2
Superiority or Other (legacy)
Arm I: TMZ, Arm II: TMZ + Thalidomide, Arm III: TMZ + Celecoxib and Arm VI: TMZ + Thalidomide + Celecoxib
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Units
Counts
Participants
OG00074
OG00181
Title
Denominators
Categories
Title
Measurements
OG0006.6(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG0019.1(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.3
2-Sided
95
0.9
1.8
Superiority or Other (legacy)
Arm V: TMZ + Isotretinoin + Celecoxib, Arm VI: TMZ + Thalidomide + Celecoxib and Arm VII: Thalidomide + Celecoxib + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Units
Counts
Participants
OG00060
OG00158
Title
Denominators
Categories
Title
Measurements
OG0008.3(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG0018.2(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.9
2-Sided
95
0.6
1.3
Superiority or Other (legacy)
OG003
Arm IV: TMZ + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG004
Arm V: TMZ + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG005
Arm VI: TMZ + Thalidomide + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
OG006
Arm VII: TMZ + Thalidomide + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
OG007
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Units
Counts
Participants
OG00022
OG00118
OG00221
OG00321
OG00421
OG00520
OG00617
OG00715
Title
Denominators
Categories
Title
Measurements
OG00010.5(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG0017.7(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00213.4(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG0036.5(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00411.6(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG0057.9(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG0066.2(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG0075.8(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
Arm I: TMZ, Arm III: TMZ + Celecoxib, Arm IV: TMZ + Isotretinoin and Arm V: TMZ + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Units
Counts
Participants
OG00070
OG00185
Title
Denominators
Categories
Title
Measurements
OG00018.3(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00117.4(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.0
2-Sided
95
0.7
1.5
Superiority or Other (legacy)
Arm I: TMZ, Arm II: TMZ + Thalidomide, Arm IV: TMZ + Isotretinoin and Arm VII: TMZ + Thalidomide + Isotretinoin.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Units
Counts
Participants
OG00074
OG00181
Title
Denominators
Categories
Title
Measurements
OG00020.2(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00117.1(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.8
2-Sided
95
0.5
1.2
Superiority or Other (legacy)
Arm I: TMZ, Arm II: TMZ + Thalidomide, Arm III: TMZ + Celecoxib and Arm VI: TMZ + Thalidomide + Celecoxib
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Units
Counts
Participants
OG00074
OG00181
Title
Denominators
Categories
Title
Measurements
OG00017.1(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00119.9(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.2
2-Sided
95
0.8
1.8
Superiority or Other (legacy)
Arm V: TMZ + Isotretinoin + Celecoxib, Arm VI: TMZ + Thalidomide + Celecoxib and Arm VII: Thalidomide + Celecoxib + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Units
Counts
Participants
OG00060
OG00158
Title
Denominators
Categories
Title
Measurements
OG00017.0(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00120.1(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.7
2-Sided
95
0.5
1.1
Superiority or Other (legacy)
OG003
Arm IV: TMZ + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG004
Arm V: TMZ + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
OG005
Arm VI: TMZ + Thalidomide + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
OG006
Arm VII: TMZ + Thalidomide + Isotretinoin
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
OG007
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
Celecoxib: 400 mg orally twice a day continuous dosing.
Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).
Units
Counts
Participants
OG00022
OG00118
OG00221
OG00321
OG00421
OG00520
OG00617
OG00715
Title
Denominators
Categories
Title
Measurements
OG00021.2(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00117.4(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00218.1(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00311.7(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00423.1(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00520.2(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00617.9(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful
OG00718.5(NA to NA)95% Confidence Interval values are not available to be reported as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, but were unsuccessful