Trial Outcomes & Findings for Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas (NCT NCT00004259)

NCT ID: NCT00004259

Last Updated: 2019-09-12

Results Overview

Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Per the protocol, the pilot arms were not included in the Phase III analyses.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 230 participants
• Primary outcome timeframe: From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.
• Results posted on: 2019-09-12

Participant Flow

Participant milestones

Measure	Radiation Therapy + Temozolomide (TMZ) Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles	Pilot Arm #1: RT+TMZ+BCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles	Pilot Arm #2: RT+TMZ+BCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
Overall Study STARTED	98	103	15	14
Overall Study COMPLETED	97	99	15	14
Overall Study NOT COMPLETED	1	4	0	0

Reasons for withdrawal

Measure	Radiation Therapy + Temozolomide (TMZ) Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles	Pilot Arm #1: RT+TMZ+BCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles	Pilot Arm #2: RT+TMZ+BCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
Overall Study Protocol Violation	1	2	0	0
Overall Study Withdrawal by Subject	0	2	0	0

Baseline Characteristics

Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas

Baseline characteristics by cohort

Measure	Radiation Therapy + Temozolomide (TMZ) n=97 Participants Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU n=99 Participants Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles	Pilot Arm #1: RT+TMZ+BCNU n=15 Participants Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles	Pilot Arm #2: RT+TMZ+BCNU n=14 Participants Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles	Total n=225 Participants Total of all reporting groups
Age, Continuous	42 years n=93 Participants	43 years n=4 Participants	48 years n=27 Participants	41 years n=483 Participants	43 years n=36 Participants
Sex: Female, Male Female	42 Participants n=93 Participants	47 Participants n=4 Participants	5 Participants n=27 Participants	6 Participants n=483 Participants	100 Participants n=36 Participants
Sex: Female, Male Male	55 Participants n=93 Participants	52 Participants n=4 Participants	10 Participants n=27 Participants	8 Participants n=483 Participants	125 Participants n=36 Participants

PRIMARY outcome

Timeframe: From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.

Population: Eligible randomized patients

Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Per the protocol, the pilot arms were not included in the Phase III analyses.

Outcome measures

Measure	Radiation Therapy + Temozolomide (TMZ) n=97 Participants Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU n=99 Participants Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
(Phase III) Overall Survival (OS)	3.9 years Interval 3.0 to 7.0	3.8 years Interval 2.2 to 7.0

PRIMARY outcome

Timeframe: From start of treatment to 3 months

Population: Eligible patients who started study treatment on Pilot Arms 1 and 2

Adverse events were graded using CTCAE v2.0. Grade refers to the severity of the adverse event (AE). The CTCAE v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Dose limiting toxicity (DLT) was defined as grade 3+ pulmonary toxicity, grade 4+ thrombocytopenia (< 25,000 for 5 days), neutropenia (< 500/microl for 7 days), or neutropenia of any duration with fever requiring hospital admission after one dose reduction of 50% in BCNU. A 20% rate of grade 3+ pulmonary toxicities or a 40% rate of grade 4+ thrombocytopenia and neutropenia was considered unacceptable for a treatment arm combining RT, TMZ, and BCNU.

Outcome measures

Measure	Radiation Therapy + Temozolomide (TMZ) n=15 Participants Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU n=13 Participants Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
(Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms Subjects with Pulmonary DLT	1 Participants	0 Participants
(Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms Subjects with Hematologic DLT	4 Participants	3 Participants

SECONDARY outcome

Timeframe: From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.

Population: Eligible randomized patients

Three-year rate is reported. Progression is defined as a radiographic increase in size of the lesion by > 25%, recurrence of the study lesion, or the development of new lesions, confirmed by imaging. Time to tumor progression was estimated using the cumulative incidence function (CIF) on tumor progression, with death as a competing risk. Per the protocol, the pilot arms were not included in the Phase III analyses.

Outcome measures

Measure	Radiation Therapy + Temozolomide (TMZ) n=97 Participants Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU n=99 Participants Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
(Phase III) Time to Tumor Progression (TTP)	45.4 months Interval 35.2 to 55.0	54.7 months Interval 44.2 to 63.9

SECONDARY outcome

Timeframe: From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.

Population: Eligible randomized patients who started study treatment

Adverse events were graded using CTCAE v2.0. Grade refers to the severity of the AE. The CTCAE v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The number of patients with grade or higher toxicity was calculated overall and for non-hematologic toxicity only. Per the protocol, the pilot arms were not included in the Phase III analyses.

Outcome measures

Measure	Radiation Therapy + Temozolomide (TMZ) n=96 Participants Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU n=99 Participants Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
(Phase III) Number of Patients With Grade 3 or Higher Toxicity Overall toxicity	46 participants	75 participants
(Phase III) Number of Patients With Grade 3 or Higher Toxicity Non-hematologic toxicity	31 participants	34 participants

SECONDARY outcome

Timeframe: From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.

Population: Eligible patients with MGMT data

Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Tumor tissue samples were analyzed for methylation status of methyl guanine methyl transferase (MGMT), classified as methylated vs. unmethylated.

Outcome measures

Measure	Radiation Therapy + Temozolomide (TMZ) n=36 Participants Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU n=22 Participants Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
(Phase III) Survival Time by MGMT Status	7.2 years Interval 4.5 to Not reached	3.1 years Interval 1.5 to 8.7

SECONDARY outcome

Timeframe: From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.

Population: Eligible patients with MGMT data

Progression is defined as a radiographic increase in size of the lesion by > 25%, recurrence of the study lesion, or the development of new lesions, confirmed by imaging. Progression-free survival time is defined as time from randomization to date of progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Tumor tissue samples were analyzed for methylation status of methyl guanine methyl transferase (MGMT), classified as methylated vs. unmethylated.

Outcome measures

Measure	Radiation Therapy + Temozolomide (TMZ) n=36 Participants Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU n=22 Participants Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
(Phase III) Progression-free Survival by MGMT Status	4.0 years Interval 1.4 to 7.5	2.1 years Interval 0.8 to 5.6

Adverse Events

Radiation Therapy + Temozolomide (TMZ)

Serious events: 43 serious events

Other events: 94 other events

Deaths: 0 deaths

RT + BCNU/CCNU

Serious events: 72 serious events

Other events: 95 other events

Deaths: 0 deaths

Pilot Arm #1: RT+TMZ+BCNU

Serious events: 8 serious events

Other events: 14 other events

Deaths: 0 deaths

Pilot Arm #2: RT+TMZ+BCNU

Serious events: 11 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Radiation Therapy + Temozolomide (TMZ) n=96 participants at risk Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU n=99 participants at risk Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles	Pilot Arm #1: RT+TMZ+BCNU n=15 participants at risk Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles	Pilot Arm #2: RT+TMZ+BCNU n=13 participants at risk Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
Blood and lymphatic system disorders Febrile neutropenia	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.0% 4/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemoglobin decreased	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	14.1% 14/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.0% 3/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Packed red blood cell transfusion	2.1% 2/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Platelet transfusion	3.1% 3/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.1% 10/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Edema NOS	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Myocardial ischaemia	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Otitis externa (exc boil of meatus) NOS	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Otitis media serous NOS	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Eye disorders Late RT Toxicity:Eye NOS	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Caecitis	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea NOS	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting NOS	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Constitutional symptons-Other	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Late RT Toxicity:Other NOS	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain-other	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection NOS	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with grade 3 or 4 neutropenia	2.1% 2/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.0% 4/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection, Other	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alanine aminotransferase increased	2.1% 2/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Bilirbin-graft versus host disease	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Gamma-glutamyltransferase increased	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Leukopenia NOS	4.2% 4/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.1% 9/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.0% 3/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	30.8% 4/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphopenia	3.1% 3/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.1% 7/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutropenia	13.5% 13/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	43.4% 43/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	40.0% 6/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	38.5% 5/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophils/granulocytes for BMT	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	16.7% 16/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	43.4% 43/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	40.0% 6/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	69.2% 9/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Pulmonary function test NOS decreased	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight decreased	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Acidosis NOS	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia NOS	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperuricemia	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypokalemia	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Amnesia NEC	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Ataxia NEC	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Cerebral ischaemia	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Convulsions NOS	3.1% 3/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.0% 4/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Depressed level of consciousness	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness (exc vertigo)	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache NOS	4.2% 4/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.0% 4/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Hemorrhagic stroke	2.1% 2/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Late RT Toxicity:Brain NOS	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral motor neuropathy	6.2% 6/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Speech disorder NEC	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Syncope	2.1% 2/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Vertigo NEC	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Depression NEC	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Euphoric mood	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Personality change	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Renal failure NOS	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary incontinence	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea NOS	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.0% 3/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pulmonary-other	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Culture wound positive	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	2.1% 2/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Erythema multiforme	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Petechiae	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypertension NOS	1.0% 1/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Thrombosis NOS	2.1% 2/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events

Measure	Radiation Therapy + Temozolomide (TMZ) n=96 participants at risk Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles	RT + BCNU/CCNU n=99 participants at risk Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles	Pilot Arm #1: RT+TMZ+BCNU n=15 participants at risk Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles	Pilot Arm #2: RT+TMZ+BCNU n=13 participants at risk Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
Blood and lymphatic system disorders Hematologic-Other	4.2% 4/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.1% 5/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemoglobin decreased	33.3% 32/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	59.6% 59/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	86.7% 13/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	100.0% 13/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Edema NOS	3.1% 3/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.1% 6/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Hearing impaired	5.2% 5/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.1% 9/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Hearing-Other	8.3% 8/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.1% 6/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Eye disorders Vision blurred	12.5% 12/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.1% 10/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	38.5% 37/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	8.1% 8/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.0% 3/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea NOS	13.5% 13/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	12.1% 12/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dry mouth	5.2% 5/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.1% 5/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dyspepsia	9.4% 9/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.1% 5/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophagitis NOS	5.2% 5/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.0% 1/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	78.1% 75/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	42.4% 42/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	46.7% 7/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	53.8% 7/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Stomatitis	9.4% 9/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.0% 3/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting NOS	35.4% 34/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	16.2% 16/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.0% 3/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	81.2% 78/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	73.7% 73/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	60.0% 9/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	69.2% 9/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Late RT Toxicity:Other NOS	17.7% 17/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	17.2% 17/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	26.7% 4/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	23.1% 3/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain-other	9.4% 9/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	11.1% 11/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pyrexia	2.1% 2/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.1% 6/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection NOS	10.4% 10/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.1% 6/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Late RT Toxicity:Skin(within RT field)NOS	13.5% 13/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	11.1% 11/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.0% 3/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alanine aminotransferase increased	22.9% 22/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	21.2% 21/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.0% 3/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Aspartate aminotransferase increased	21.9% 21/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	18.2% 18/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	33.3% 5/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood alkaline phosphatase NOS increased	13.5% 13/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	18.2% 18/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Leukopenia NOS	38.5% 37/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	70.7% 70/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	80.0% 12/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	76.9% 10/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphopenia	15.6% 15/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.1% 13/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Metabolic-Other	5.2% 5/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.0% 4/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutropenia	17.7% 17/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	45.5% 45/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	26.7% 4/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	45.8% 44/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	63.6% 63/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	60.0% 9/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	84.6% 11/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Pulmonary function test NOS decreased	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.1% 9/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	33.3% 5/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	23.1% 3/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight decreased	10.4% 10/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.1% 10/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	23.1% 3/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Anorexia	32.3% 31/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	23.2% 23/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	40.0% 6/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	23.1% 3/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia NOS	9.4% 9/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.1% 7/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypocalcemia	7.3% 7/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.1% 7/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	26.7% 4/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypokalemia	6.2% 6/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.1% 5/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.0% 3/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	3.1% 3/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.1% 6/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	26.7% 4/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Arthralgia	5.2% 5/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness NOS	12.5% 12/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.1% 5/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	23.1% 3/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Myalgia	6.2% 6/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.0% 4/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Amnesia NEC	14.6% 14/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.1% 13/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Ataxia NEC	4.2% 4/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.1% 5/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Convulsions NOS	13.5% 13/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.1% 13/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	23.1% 3/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness (exc vertigo)	16.7% 16/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.1% 13/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache NOS	46.9% 45/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	31.3% 31/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	53.8% 7/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Late RT Toxicity:Brain NOS	11.5% 11/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	14.1% 14/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.0% 3/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	30.8% 4/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Learning disorder NOS	5.2% 5/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.0% 3/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral motor neuropathy	11.5% 11/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.1% 7/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	14.6% 14/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.1% 9/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Speech disorder NEC	8.3% 8/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.0% 4/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Taste disturbance	14.6% 14/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.1% 13/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.0% 3/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Tremor NEC	7.3% 7/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.0% 4/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Anxiety NEC	12.5% 12/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.1% 9/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Confusion	2.1% 2/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.1% 10/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Depression NEC	12.5% 12/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.1% 6/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.7% 1/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Insomnia NEC	18.8% 18/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	8.1% 8/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	9.4% 9/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.1% 7/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea NOS	7.3% 7/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.1% 13/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	38.5% 5/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Alopecia	58.3% 56/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	58.6% 58/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	40.0% 6/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	69.2% 9/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	13.5% 13/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.1% 7/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dermatitis radiation NOS	17.7% 17/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	16.2% 16/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 2/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 1/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Injection site reaction NOS	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	8.1% 8/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.4% 2/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin-Other	6.2% 6/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 2/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Phlebitis superficial	0.00% 0/96 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.1% 5/99 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/15 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/13 Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: seiferheldw@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
• Publication restrictions are in place

Restriction type: OTHER