Trial Outcomes & Findings for Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma (NCT NCT00305864)

Last Updated: 2018-03-05

Results Overview

Patients were to be followed for a minimum of 90 days from the start of radiation therapy (RT) and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as a grade 4 neurologic adverse event (AE) considered to be related to treatment occurring within 21 days of the conclusion of RT. For each dose level, up to seven patients were to be accrued to assure that there would be six eligible for treatment adverse event evaluation. A dose level of MGd was considered acceptable if no more than 1 patient of the 6 experience a DLT. If the current level was considered acceptable, then dose escalation occurred. Otherwise, the preceding dose level would be declared the maximum tolerated dose (MTD). The MTD would be used for the Phase II arm. Rating scale: 0 = not the MTD, 1 = MTD

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

118 participants

Primary outcome timeframe

From start of radiation therapy to 90 days,

Results posted on

2018-03-05

Participant Flow

In multicenter clinical trials the accrual closure date must be predicted so that sites can be notified weeks in advance. As expected, this process often results in a final number of patients differing from the planned accrual.

Participant milestones

Participant milestones
Measure	Phase I: MGd 3 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 4 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 5 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase II: MGd 5 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	7	10	7	94
Overall Study COMPLETED	7	9	6	81
Overall Study NOT COMPLETED	0	1	1	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I: MGd 3 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 4 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 5 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase II: MGd 5 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Ineligible / No protocol treatment	0	1	1	13

Baseline Characteristics

Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: MGd 3 mg/kg n=7 Participants Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 4 mg/kg n=10 Participants Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 5 mg/kg n=7 Participants Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase II: MGd 5 mg/kg n=94 Participants Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Total n=118 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	57.5 years n=7 Participants	58 years n=5 Participants	57.5 years n=4 Participants	57 years n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	33 Participants n=4 Participants	44 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	61 Participants n=4 Participants	74 Participants n=21 Participants

PRIMARY outcome

Timeframe: From start of radiation therapy to 90 days,

Population: Eligible patients who received protocol treatment.

Outcome measures

Outcome measures
Measure	Phase I: MGd 3 mg/kg n=7 Participants Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 4 mg/kg n=9 Participants Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: 5 mg/kg n=6 Participants Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Maximum Tolerated Dose of MGd (Phase I)	0 units on a scale	0 units on a scale	1 units on a scale

PRIMARY outcome

Timeframe: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months

Population: All eligible patients.

Survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Outcome measures
Measure	Phase I: MGd 3 mg/kg n=87 Participants Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 4 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: 5 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Median Overall Survival (Phase II)	15.6 Months Interval 12.9 to 17.6	—	—

SECONDARY outcome

Timeframe: From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months.

Population: All eligible patients

Progression will be defined as a \> 25% increase in tumor area. Progression-free survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Outcome measures
Measure	Phase I: MGd 3 mg/kg n=87 Participants Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 4 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: 5 mg/kg Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Progression-free Survival (Phase II)	7.6 months Interval 5.7 to 9.6	—	—

Adverse Events

Phase I: MGd 3 mg/kg

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Phase I: MGd 4 mg/kg

Serious events: 6 serious events

Other events: 9 other events

Deaths: 0 deaths

Phase I: MGd 5 mg/kg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase II: MGd 5 mg/kg

Serious events: 48 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Phase I: MGd 3 mg/kg n=7 participants at risk Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 4 mg/kg n=9 participants at risk Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 5 mg/kg n=6 participants at risk Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase II: MGd 5 mg/kg n=81 participants at risk Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	4.9% 4/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	22.2% 18/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Blood and lymphatic system disorders Anemia	14.3% 1/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	22.2% 2/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	3.7% 3/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 1/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Cardiac disorders - Other	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Sinus tachycardia	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Colitis	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Diarrhea	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Dysphagia	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Enterocolitis	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Esophagitis	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Mucositis oral	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Nausea	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Pancreatitis	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Vomiting	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
General disorders Chills	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	4.9% 4/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
General disorders Death NOS	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
General disorders Edema limbs	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
General disorders Facial pain	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
General disorders Fatigue	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	13.6% 11/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
General disorders Fever	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.7% 1/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	14.8% 12/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
General disorders Non-cardiac chest pain	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.7% 1/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
General disorders Sudden death NOS	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Immune system disorders Allergic reaction	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 1/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	4.9% 4/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Bronchial infection	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Infections and infestations - Other	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.7% 1/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	4.9% 4/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Lung infection	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Phlebitis infective	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Urinary tract infection	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Wound infection	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Injury, poisoning and procedural complications Vascular access complication	14.3% 1/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Investigations Alanine aminotransferase increased	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	8.6% 7/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Investigations Alkaline phosphatase increased	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Investigations Aspartate aminotransferase increased	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	6.2% 5/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Investigations Blood bilirubin increased	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Investigations Creatinine increased	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Investigations Lymphocyte count decreased	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 1/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 9/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.

Other adverse events
Measure	Phase I: MGd 3 mg/kg n=7 participants at risk Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 4 mg/kg n=9 participants at risk Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase I: MGd 5 mg/kg n=6 participants at risk Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Phase II: MGd 5 mg/kg n=81 participants at risk Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	57.1% 4/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	22.2% 2/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	33.3% 2/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	50.6% 41/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	14.3% 1/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	22.2% 2/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Cardiac disorders - Other	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	3.7% 3/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Chest pain - cardiac	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Palpitations	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Sinus tachycardia	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 1/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Ear and labyrinth disorders Ear pain	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	3.7% 3/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Ear and labyrinth disorders External ear inflammation	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	3.7% 3/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Ear and labyrinth disorders Hearing impaired	14.3% 1/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	33.3% 2/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	6.2% 5/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 1/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Ear and labyrinth disorders Tinnitus	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	7.4% 6/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Endocrine disorders Cushingoid	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 1/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Endocrine disorders Endocrine disorders - Other	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Blurred vision	14.3% 1/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 1/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	33.3% 2/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.0% 13/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Conjunctivitis	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Dry eye	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	4.9% 4/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Extraocular muscle paresis	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.7% 1/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	4.9% 4/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Eye disorders - Other	57.1% 4/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.7% 1/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	24.7% 20/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Eye pain	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 1/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Flashing lights	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.7% 1/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Optic nerve disorder	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Photophobia	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 1/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Uveitis	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.7% 1/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Watering eyes	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Abdominal distension	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	3.7% 3/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Anal pain	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Constipation	42.9% 3/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	33.3% 3/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	33.3% 2/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	48.1% 39/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Dental caries	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	1.2% 1/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Diarrhea	57.1% 4/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	22.2% 2/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.7% 1/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	24.7% 20/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Dry mouth	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.7% 1/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	4.9% 4/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Dyspepsia	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	8.6% 7/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Dysphagia	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Fecal incontinence	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Flatulence	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Gastric stenosis	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	11.1% 1/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Gastritis	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Gastrointestinal disorders - Other	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Hemorrhoids	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	2.5% 2/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Mucositis oral	0.00% 0/7 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/9 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	16.7% 1/6 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.	4.9% 4/81 Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.