Trial Outcomes & Findings for Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer (NCT NCT00096265)

Last Updated: 2018-03-09

Results Overview

Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

126 participants

Primary outcome timeframe

From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Results posted on

2018-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	WBRT + SRS Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.	Temozolomide + WBRT + SRS Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Erlotinib + WBRT + SRS Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Overall Study STARTED	45	40	41
Overall Study COMPLETED	44	40	41
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	WBRT + SRS Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.	Temozolomide + WBRT + SRS Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Erlotinib + WBRT + SRS Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Overall Study Ineligible	1	0	0

Baseline Characteristics

Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	WBRT + SRS n=45 Participants Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.	Temozolomide + WBRT + SRS n=40 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Erlotinib + WBRT + SRS n=41 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.	Total n=126 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	63 years n=7 Participants	61 years n=5 Participants	63 years n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	58 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	22 Participants n=7 Participants	23 Participants n=5 Participants	68 Participants n=4 Participants

PRIMARY outcome

Timeframe: From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Population: All eligible patients.

Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.

Outcome measures

Outcome measures
Measure	WBRT + SRS n=44 Participants Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.	Temozolomide + WBRT + SRS n=40 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity	Erlotinib + WBRT + SRS n=41 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Overall Survival	13.4 months Interval 6.5 to 20.8	6.3 months Interval 3.4 to 10.1	6.1 months Interval 3.6 to 12.1

SECONDARY outcome

Timeframe: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Population: Eligible patients

CNS progression is defined as any increase in perpendicular bi-dimensional tumor area for any of the 1-3 tracked brain metastases, by any amount, or the appearance of any new brain metastasis on a follow-up MRI (SRS planning scan will not be used to evaluate CNS progression). For lesions smaller than 1 cm in maximum diameter, a maximum increase of 50% in perpendicular bi-dimensional treatment area is necessary to score as progression. This caveat is included to account for potential variability in measurement, which is most susceptible to proportionate errors at smaller sizes. For greater than 1 cm lesions, the definition uses a 25% rule for change. Rates of CNS progression estimated by the cumulative incidence method, with death treated as a competing risk.

Outcome measures

Outcome measures
Measure	WBRT + SRS n=44 Participants Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.	Temozolomide + WBRT + SRS n=40 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity	Erlotinib + WBRT + SRS n=41 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Rate of CNS Progression (One Year)	34.1 percentage of participants Interval 19.8 to 48.4	47.4 percentage of participants Interval 31.0 to 63.8	27.4 percentage of participants Interval 13.2 to 41.5

SECONDARY outcome

Timeframe: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Population: Eligible patients with any follow-up EQ-5D

Quality-adjusted life years (QALY) incorporate the societal-based utilities of health states into expected life years for a health condition. The QALY model is QALY(h,y) where h is a health state and y is the years of life. Higher quality-adjusted life year values represent a better outcome. A patient's health state will be determined from the index score of the EQ-5D-5L patient questionnaire.The EQ-5D-5L is a 2-part self-assessment questionnaire, a 5-item index score and a visual analogue scale, but only the index score is used for quality-adjusted survival. The index score has 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state).

Outcome measures

Outcome measures
Measure	WBRT + SRS n=24 Participants Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.	Temozolomide + WBRT + SRS n=19 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity	Erlotinib + WBRT + SRS n=18 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument	16.9 Quality-adjusted life years Standard Deviation 9.6	15.9 Quality-adjusted life years Standard Deviation 12.0	14.4 Quality-adjusted life years Standard Deviation 12.5

SECONDARY outcome

Timeframe: From randomization to three months.

Population: Eligible patients with both baseline and 3 month data

The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score, which ranges from 0 to 76. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-Br including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL. A change of 5 points will be considered a minimal clinically meaningful change. Change from baseline at three months (3 month score - baseline score) will be categorized as improvement if increased, stable if no change, or deterioration if decreased.

Outcome measures

Outcome measures
Measure	WBRT + SRS n=26 Participants Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.	Temozolomide + WBRT + SRS n=16 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity	Erlotinib + WBRT + SRS n=17 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months Deterioration/Decrease	12 Participants	10 Participants	11 Participants
Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months Stable	8 Participants	2 Participants	6 Participants
Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months Improvement/Increase	6 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: From randomization to six months.

Population: Eligible patients with baseline and 6 month data

Compared between two treatment arms using a two-group chi-squared test. Zubrod score will be collected at baseline and follow-up. The Zubrod performance score runs from 0 to 5, with 0 denoting perfect health and 5 death. Change from baseline is calculated as 6-month value - baseline value. Patients with a baseline score who have died by six months will be included in the analysis with a score of 5 at six months.

Outcome measures

Outcome measures
Measure	WBRT + SRS n=40 Participants Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.	Temozolomide + WBRT + SRS n=35 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity	Erlotinib + WBRT + SRS n=35 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Change in Performance Status at Six Months Improvement (decrease)	0 Participants	1 Participants	3 Participants
Change in Performance Status at Six Months Stable (no change)	19 Participants	4 Participants	2 Participants
Change in Performance Status at Six Months Deterioration (increase)	21 Participants	30 Participants	30 Participants

SECONDARY outcome

Timeframe: From randomization to six months.

Population: Eligible patients with both baseline and 6 month steroid dose

Daily steroid dose will be collected at baseline and follow-up, as one of the following: 0-4 mg, \>4 to ≤ 8 mg, \>8 to ≤12 mg, and \>12 mg. Change from baseline at six months will be evaluated to have decreased, remained stable, or increased, based on these categories.

Outcome measures

Outcome measures
Measure	WBRT + SRS n=26 Participants Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.	Temozolomide + WBRT + SRS n=18 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity	Erlotinib + WBRT + SRS n=17 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Change in Steroid Dependence at Six Months Decrease	12 Participants	10 Participants	10 Participants
Change in Steroid Dependence at Six Months Stable	10 Participants	4 Participants	6 Participants
Change in Steroid Dependence at Six Months Increase	4 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Population: Eligible patients who died

Patients were considered to have died neurologic deaths (coded as "Brain Metastases") if they had stable systemic disease and progressive neurologic disease consisting of expanding intracranial masses, CNS hemorrhages, hydrocephalus resulting in herniation or fulminant meningeal carcinomatosis.

Outcome measures

Outcome measures
Measure	WBRT + SRS n=35 Participants Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.	Temozolomide + WBRT + SRS n=34 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity	Erlotinib + WBRT + SRS n=36 Participants Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Cause of Death (Neurologic vs Other) Other	29 Participants	29 Participants	29 Participants
Cause of Death (Neurologic vs Other) Neuroligic death	6 Participants	5 Participants	7 Participants

Adverse Events

WBRT+SRS

Serious events: 10 serious events

Other events: 28 other events

Deaths: 0 deaths

Temozolomide+WBRT+SRS

Serious events: 22 serious events

Other events: 32 other events

Deaths: 0 deaths

Erlotinib+WBRT+SRS

Serious events: 12 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld

Radiation Therapy Oncology Group

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	WBRT+SRS n=44 participants at risk Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery. \[Data is reported for eligible patients with adverse event information, which is 44 patients.\]	Temozolomide+WBRT+SRS n=39 participants at risk Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. \[Data is reported for eligible patients with adverse event information, which is 39 patients.\]	Erlotinib+WBRT+SRS n=41 participants at risk Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months. \[Data is reported for eligible patients with adverse event information, which is 41 patients.\]
Blood and lymphatic system disorders Anemia	4.5% 2/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	12.8% 5/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	9.8% 4/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Blood and lymphatic system disorders Hemolysis	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Cardiac disorders Cardiac disorders - Other	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Cardiac disorders Myocardial infarction	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Abdominal pain	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Nausea	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Vomiting	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Death NOS	6.8% 3/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	4.9% 2/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Edema limbs	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Fatigue	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	4.9% 2/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Fever	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders General disorders and administration site conditions - Other	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Non-cardiac chest pain	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Sudden death NOS	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Infections and infestations - Other	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Lung infection	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Injury, poisoning and procedural complications Fracture	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Creatinine increased	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations GGT increased	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations INR increased	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Investigations - Other	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Platelet count decreased	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	10.3% 4/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	4.9% 2/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Weight loss	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	4.9% 2/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations White blood cell decreased	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Anorexia	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Dehydration	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.

Other adverse events
Measure	WBRT+SRS n=44 participants at risk Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery. \[Data is reported for eligible patients with adverse event information, which is 44 patients.\]	Temozolomide+WBRT+SRS n=39 participants at risk Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. \[Data is reported for eligible patients with adverse event information, which is 39 patients.\]	Erlotinib+WBRT+SRS n=41 participants at risk Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months. \[Data is reported for eligible patients with adverse event information, which is 41 patients.\]
Blood and lymphatic system disorders Anemia	15.9% 7/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	30.8% 12/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	26.8% 11/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	7.7% 3/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Cardiac disorders Atrial fibrillation	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Cardiac disorders Cardiac disorders - Other	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Cardiac disorders Myocardial infarction	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Cardiac disorders Sinus tachycardia	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders Ear and labyrinth disorders - Other	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders Ear pain	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders External ear inflammation	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders External ear pain	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders Hearing impaired	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	4.9% 2/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Endocrine disorders Cushingoid	4.5% 2/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Blurred vision	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	7.7% 3/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Conjunctivitis	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Dry eye	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	7.3% 3/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Extraocular muscle paresis	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Eye disorders - Other	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	7.3% 3/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Eye pain	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Optic nerve disorder	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Photophobia	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Watering eyes	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Abdominal distension	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Abdominal pain	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	7.7% 3/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Constipation	6.8% 3/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	25.6% 10/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	24.4% 10/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Dental caries	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Diarrhea	6.8% 3/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	7.7% 3/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	34.1% 14/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Dry mouth	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	7.3% 3/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Dyspepsia	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	10.3% 4/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Dysphagia	4.5% 2/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	5.1% 2/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	7.3% 3/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Fecal incontinence	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Flatulence	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Gastrointestinal disorders - Other	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Mucositis oral	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	10.3% 4/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	4.9% 2/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Nausea	15.9% 7/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	33.3% 13/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	36.6% 15/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Aspartate aminotransferase increased	2.3% 1/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	7.7% 3/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	24.4% 10/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	0.00% 0/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.4% 1/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Stomach pain	0.00% 0/44 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	2.6% 1/39 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.	4.9% 2/41 Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.