Trial Outcomes & Findings for Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG) (NCT NCT00953121)

Last Updated: 2013-09-16

Results Overview

Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Response Assessment in Neuro-Oncology (RANO) criteria, or to death due to any cause. Progression is defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. Patients may also be classified as progressive disease with significant neurologic decline felt to be due to underlying tumor and not attributable to co-morbid event or concurrent medication regardless of MRI findings.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

104 participants

Primary outcome timeframe

6 months

Results posted on

2013-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Grade IV, No Bevacizumab Failure Recurrent Glioblastoma Multiforme (GBM) patients who have not previously failed bevacizumab, irinotecan, or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an area under the curve (AUC) of 4.	Grade III, No Bevacizumab Failure Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade IV, Bevacizumab Failure Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.
Overall Study STARTED	40	39	25
Overall Study COMPLETED	40	39	25
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Grade IV, No Bevacizumab Failure n=40 Participants Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade III, No Bevacizumab Failure n=39 Participants Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade IV, Bevacizumab Failure n=25 Participants Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Total n=104 Participants Total of all reporting groups
Age Continuous	51 years n=93 Participants	47 years n=4 Participants	52 years n=27 Participants	50 years n=483 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	11 Participants n=4 Participants	8 Participants n=27 Participants	29 Participants n=483 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	28 Participants n=4 Participants	17 Participants n=27 Participants	75 Participants n=483 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Grade IV, No Bevacizumab Failure n=40 Participants Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade III, No Bevacizumab Failure n=39 Participants Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade IV, Bevacizumab Failure n=25 Participants Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.
6 Month Progression-free Survival	47.5 percentage of participants Interval 31.6 to 61.8	71.1 percentage of participants Interval 53.9 to 82.8	24.0 percentage of participants Interval 9.8 to 41.7

SECONDARY outcome

Timeframe: 34 months

Population: The number of participants analyzed is lower than the total number in the study for each arm due to the fact that some patients progressed or experienced an adverse event which resulted in being taken off study during the first cycle and thus were never evaluated for radiographic response.

Percentage of participants with an objective response (complete response or partial response) based on Response Assessment in Neuro-Oncology (RANO) criteria. A complete response is defined as disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses. A partial response is defined as greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose.

Outcome measures

Outcome measures
Measure	Grade IV, No Bevacizumab Failure n=35 Participants Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade III, No Bevacizumab Failure n=36 Participants Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade IV, Bevacizumab Failure n=24 Participants Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.
Objective Response Rate	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 40 months

Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Grade IV, No Bevacizumab Failure n=40 Participants Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade III, No Bevacizumab Failure n=39 Participants Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade IV, Bevacizumab Failure n=25 Participants Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.
Median Progression Free Survival (PFS)	5.9 months Interval 4.8 to 8.5	10.0 months Interval 7.3 to 12.1	3.6 months Interval 2.7 to 4.3

SECONDARY outcome

Timeframe: 40 months

Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Grade IV, No Bevacizumab Failure n=40 Participants Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade III, No Bevacizumab Failure n=39 Participants Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade IV, Bevacizumab Failure n=25 Participants Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.
Median Overall Survival (OS)	9.3 months Interval 7.0 to 11.9	16.0 months Interval 12.2 to 21.9	5.9 months Interval 4.0 to 8.5

SECONDARY outcome

Timeframe: 34 months

Number of patients experiencing a toxicity greater than or equal to grade 2 treatment-related toxicity

Outcome measures

Outcome measures
Measure	Grade IV, No Bevacizumab Failure n=40 Participants Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade III, No Bevacizumab Failure n=39 Participants Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade IV, Bevacizumab Failure n=25 Participants Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.
Safety of Bevacizumab (Avastin) in Combination With Irinotecan and Carboplatin	39 participants	39 participants	23 participants

Adverse Events

Grade IV, No Bevacizumab Failure

Serious events: 17 serious events

Other events: 34 other events

Deaths: 0 deaths

Grade III, No Bevacizumab Failure

Serious events: 10 serious events

Other events: 37 other events

Deaths: 0 deaths

Grade IV, Bevacizumab Failure

Serious events: 6 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Annick Desjardins

Preston Robert Tisch Brain Tumor Center at Duke University Medical Center

Phone: 919-684-1691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Grade IV, No Bevacizumab Failure n=40 participants at risk Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade III, No Bevacizumab Failure n=39 participants at risk Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade IV, Bevacizumab Failure n=25 participants at risk Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.
Blood and lymphatic system disorders Anemia	5.0% 2/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	8.0% 2/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Colitis	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Colonic perforation	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Constipation	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Diarrhea	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Duodenal hemorrhage	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Esophagitis	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: Fistula, GI: Small bowel NOS	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Mucositis oral	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Nausea	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Small intestinal perforation	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Vomiting	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
General disorders Death NOS	17.5% 7/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
General disorders Fatigue	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
General disorders Sudden death NOS	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Esophageal infection	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Infections and infestations - Other, specify: Infection with Gr 3 or 4 neutrophils: Lung (pneumonia)	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Infections and infestations - Other, specify: Infection with Gr 3 or 4 neutrophils: Pharynx	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Infections and infestations - Other, specify: Infection with Gr 3, 4 neutrophils: Skin (cellulitis)	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Infections and infestations - Other, specify: Infection with Gr 3 or 4 neutrophils: Trachea	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Lung infection	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Meningitis	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Wound infection	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Investigations Creatinine increased	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Investigations Neutrophil count decreased	5.0% 2/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	5.1% 2/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Investigations Platelet count decreased	5.0% 2/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Metabolism and nutrition disorders Anorexia	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Metabolism and nutrition disorders Dehydration	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Metabolism and nutrition disorders Hyponatremia	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	5.1% 2/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Nervous system disorders Ataxia	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Nervous system disorders Cognitive disturbance	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Nervous system disorders Encephalopathy	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Nervous system disorders Headache	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Nervous system disorders Intracranial hemorrhage	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Nervous system disorders Peripheral motor neuropathy	5.0% 2/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov

Other adverse events
Measure	Grade IV, No Bevacizumab Failure n=40 participants at risk Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade III, No Bevacizumab Failure n=39 participants at risk Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.	Grade IV, Bevacizumab Failure n=25 participants at risk Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.
Blood and lymphatic system disorders Anemia	20.0% 8/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	17.9% 7/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	16.0% 4/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Cardiac disorders Palpitations	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Ear and labyrinth disorders Hearing impaired	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Eye disorders Optic nerve disorder	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Abdominal pain	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Colitis	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Constipation	7.5% 3/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	17.9% 7/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	8.0% 2/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Diarrhea	17.5% 7/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	15.4% 6/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Esophagitis	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Gastritis	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: Gastroesophageal Reflux	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Hemorrhoids	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	5.1% 2/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Mucositis oral	5.0% 2/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Nausea	17.5% 7/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	38.5% 15/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	24.0% 6/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Oral hemorrhage	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Gastrointestinal disorders Vomiting	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	12.8% 5/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	12.0% 3/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
General disorders Edema limbs	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
General disorders Fatigue	52.5% 21/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	59.0% 23/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	24.0% 6/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
General disorders Injection site reaction	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	5.1% 2/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
General disorders Non-cardiac chest pain	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Immune system disorders Immune system disorders - Other, specify: Infusion reaction to CPT-11	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Bronchial infection	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Infections and infestations - Other, specify: Infection with normal ANC - Herpes Zoster	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Infections and infestations - Other, specify: Shingles	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Joint infection	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Lip infection	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Sinusitis	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Skin infection	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Upper respiratory infection	12.5% 5/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Infections and infestations Urinary tract infection	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	5.1% 2/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Injury, poisoning and procedural complications Fracture	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Injury, poisoning and procedural complications Seroma	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	2.6% 1/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Injury, poisoning and procedural complications Wound dehiscence	2.5% 1/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Investigations Alanine aminotransferase increased	7.5% 3/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	5.1% 2/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	8.0% 2/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Investigations Aspartate aminotransferase increased	5.0% 2/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Investigations Neutrophil count decreased	55.0% 22/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	61.5% 24/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	76.0% 19/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Investigations Platelet count decreased	32.5% 13/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	43.6% 17/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	48.0% 12/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Investigations Weight loss	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	8.0% 2/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Investigations White blood cell decreased	0.00% 0/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	0.00% 0/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Metabolism and nutrition disorders Anorexia	5.0% 2/40 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	5.1% 2/39 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov	4.0% 1/25 • 34 months The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov