Motexafin Gadolinium, Temozolomide, and Radiation Therapy... | NCT00305864

ID	Type	Description	Link
NCI-2009-01092	Registry Identifier	CTRP (Clinical Trial Reporting Program)
CDR0000467802
RTOG 0513	Other Identifier	Radiation Therapy Oncology Group
RTOG-0513	Other Identifier	CTEP
U10CA021661	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
Radiation Therapy Oncology Group	NETWORK

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase I: MGd 3 mg/kg	Experimental	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.	Radiation: 3-Dimensional Conformal Radiation Therapy Drug: Motexafin Gadolinium Drug: Temozolomide
Phase I: MGd 4 mg/kg	Experimental	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.	Radiation: 3-Dimensional Conformal Radiation Therapy Drug: Motexafin Gadolinium Drug: Temozolomide
Phase I: MGd 5 mg/kg	Experimental	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.

Name	Type	Description	Arm Group Labels	Other Names
3-Dimensional Conformal Radiation Therapy	Radiation	Undergo radiotherapy	Phase I: MGd 3 mg/kg Phase I: MGd 4 mg/kg Phase I: MGd 5 mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose of MGd (Phase I)	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	From start of radiation therapy to 90 days,
Median Overall Survival (Phase II)	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.	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

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (Phase II)	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.	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed glioblastoma multiforme (GBM) or gliosarcoma
- Newly diagnosed by surgical biopsy or excision within the past 5 weeks
Supratentorial location, as determined by the following:
- Contrast-enhanced MRI performed preoperatively
- MRI performed postoperatively within 28 days prior to study entry (preferably within 72 hours of surgery)
- Postoperative scan not required if diagnosed by stereotactic biopsy and pre-operative MRI was performed
No gliomas graded < GBM
No recurrent malignant gliomas
No tumor foci detected below the tentorium or beyond the cranial vault
No multifocal disease or leptomeningeal spread
Zubrod performance status 0-1
Neurologic function status 0-2
Absolute neutrophil count ≥ 1,800 cells/mm^3
Platelet count ≥ 100,000 cells/mm^3
Hemoglobin ≥ 8 g/dL (transfusion allowed)
BUN ≤ 25 mg/dL
Creatinine ≤ 1.5 mg/dL
Bilirubin ≤ 1.5 mg/dL
ALT or AST ≤ 2 times upper limit of normal
Fertile patients must use effective contraception during and for 2 months after completion of study treatment
Negative pregnancy test
Not pregnant or nursing
No prior invasive malignancies, except for nonmelanomatous skin cancer and carcinoma in situ of the uterine cervix or bladder, unless disease-free for ? 3 years
No severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at study entry
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to study entry
- Coagulation defects
- Known AIDS
No prior allergic reaction to the study drugs
No history of porphyria or G6PD deficiency
No allergy to gadolinium or contraindications to MRI
No other concurrent chemotherapy
Recovered from effects of surgery or postoperative infection and other complications
No prior systemic chemotherapy, including polifeprosan 20 with carmustine implant (Gliadel wafer), for the current GBM
- Prior chemotherapy for a different cancer allowed
No prior radiotherapy to the head and neck (except for T1 glottic cancer) that would result in overlap of radiation therapy fields
No prophylactic filgrastim (G-CSF) during the first course of study treatment
No concurrent sargramostim (GM-CSF)

Name	Affiliation	Role
David Brachman	Radiation Therapy Oncology Group	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mobile Infirmary Medical Center		Mobile	Alabama	36607	United States
Arizona Oncology Services Foundation

PubMed Identifier	Type	Citation	Retractions
25832688	Result	Brachman DG, Pugh SL, Ashby LS, Thomas TA, Dunbar EM, Narayan S, Robins HI, Bovi JA, Rockhill JK, Won M, Curran WP. Phase 1/2 trials of Temozolomide, Motexafin Gadolinium, and 60-Gy fractionated radiation for newly diagnosed supratentorial glioblastoma multiforme: final results of RTOG 0513. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):961-7. doi: 10.1016/j.ijrobp.2014.12.050.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	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.
BG004	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximum Tolerated Dose of MGd (Phase I)

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

Eligible patients who received protocol treatment.

Posted

Number

units on a scale

From start of radiation therapy to 90 days,

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG0007 OG0019 OG0026

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0021

Primary

Median Overall Survival (Phase II)

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.

All eligible patients.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	All MGd 5mg/kg Patients (Phase I and II Arms Combined)	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.

Units	Counts
Participants

Secondary

Progression-free Survival (Phase II)

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.

All eligible patients

Posted

Median

95% Confidence Interval

months

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.

ID	Title	Description
OG000	All MGd 5mg/kg Patients (Phase I and II Arms Combined)	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.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	3	7	7	7
EG001	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.	6	9	9	9
EG002	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.	4	6	6	6
EG003	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.	48	81	80	81

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0012 affected9 at risk EG0020 affected6 at risk EG0033 affected81 at risk
Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Cardiac disorders - Other	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Sinus tachycardia	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Colitis	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Dysphagia	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Enterocolitis	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Esophagitis	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Mucositis oral	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Pancreatitis	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Chills	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Death NOS	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Edema limbs	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Facial pain	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Fatigue	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Fever	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Non-cardiac chest pain	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Sudden death NOS	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Allergic reaction	Immune system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Bronchial infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Infections and infestations - Other	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Lung infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Phlebitis infective	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Urinary tract infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Wound infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Alkaline phosphatase increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Blood bilirubin increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Creatinine increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Lymphocyte count decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Neutrophil count decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0013 affected9 at risk EG0020 affected6 at risk EG003
Platelet count decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0012 affected9 at risk EG0020 affected6 at risk EG003
White blood cell decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0012 affected9 at risk EG0020 affected6 at risk EG003
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Central nervous system necrosis	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Cerebrospinal fluid leakage	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Cognitive disturbance	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Depressed level of consciousness	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Dizziness	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Dysphasia	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Headache	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hydrocephalus	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Intracranial hemorrhage	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Ischemia cerebrovascular	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0002 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Memory impairment	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Nervous system disorders - Other	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Pyramidal tract syndrome	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Recurrent laryngeal nerve palsy	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Seizure	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Syncope	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Agitation	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Confusion	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Psychosis	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Acute kidney injury	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Respiratory, thoracic and mediastinal disorders - Other	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Skin and subcutaneous tissue disorders - Other	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Thromboembolic event	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected9 at risk EG0021 affected6 at risk EG003
Vascular disorders - Other	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected7 at risk EG0012 affected9 at risk EG0022 affected6 at risk EG00341 affected81 at risk
Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0012 affected9 at risk EG0020 affected6 at risk EG003
Cardiac disorders - Other	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Chest pain - cardiac	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Palpitations	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Sinus tachycardia	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Ear pain	Ear and labyrinth disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
External ear inflammation	Ear and labyrinth disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hearing impaired	Ear and labyrinth disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0022 affected6 at risk EG003
Middle ear inflammation	Ear and labyrinth disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Tinnitus	Ear and labyrinth disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Cushingoid	Endocrine disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Endocrine disorders - Other	Endocrine disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Blurred vision	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0022 affected6 at risk EG003
Conjunctivitis	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Dry eye	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Extraocular muscle paresis	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Eye disorders - Other	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Eye pain	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Flashing lights	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Optic nerve disorder	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Photophobia	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Uveitis	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Watering eyes	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Abdominal distension	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Anal pain	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected7 at risk EG0013 affected9 at risk EG0022 affected6 at risk EG003
Dental caries	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected7 at risk EG0012 affected9 at risk EG0021 affected6 at risk EG003
Dry mouth	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Dyspepsia	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Dysphagia	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Fecal incontinence	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Flatulence	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Gastric stenosis	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Gastritis	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Gastrointestinal disorders - Other	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hemorrhoids	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Mucositis oral	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected7 at risk EG0012 affected9 at risk EG0023 affected6 at risk EG003
Oral pain	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Pancreatitis	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Rectal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Stomach pain	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Toothache	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected7 at risk EG0012 affected9 at risk EG0020 affected6 at risk EG003
Chills	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Death NOS	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Edema face	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Edema limbs	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Edema trunk	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Facial pain	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Fatigue	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0006 affected7 at risk EG0017 affected9 at risk EG0025 affected6 at risk EG003
Fever	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Flu like symptoms	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Gait disturbance	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
General disorders and administration site conditions - Other	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Injection site reaction	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0013 affected9 at risk EG0021 affected6 at risk EG003
Non-cardiac chest pain	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Pain	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0022 affected6 at risk EG003
Hepatobiliary disorders - Other	Hepatobiliary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Allergic reaction	Immune system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0023 affected6 at risk EG003
Bladder infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Bronchial infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Catheter related infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Eye infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Gum infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Infections and infestations - Other	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Lip infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Mucosal infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Sinusitis	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Skin infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Soft tissue infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Tracheitis	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Upper respiratory infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Urinary tract infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Vulval infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Wound infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Bruising	Injury, poisoning and procedural complications	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Burn	Injury, poisoning and procedural complications	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Dermatitis radiation	Injury, poisoning and procedural complications	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0013 affected9 at risk EG0022 affected6 at risk EG003
Radiation recall reaction (dermatologic)	Injury, poisoning and procedural complications	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected7 at risk EG0014 affected9 at risk EG0024 affected6 at risk EG003
Alkaline phosphatase increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0013 affected9 at risk EG0020 affected6 at risk EG003
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected7 at risk EG0013 affected9 at risk EG0022 affected6 at risk EG003
Blood bilirubin increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Cholesterol high	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Creatinine increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
GGT increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Haptoglobin decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
INR increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Investigations - Other	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Lipase increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Lymphocyte count decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0013 affected9 at risk EG0021 affected6 at risk EG003
Neutrophil count decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Platelet count decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0002 affected7 at risk EG0013 affected9 at risk EG0022 affected6 at risk EG003
Serum amylase increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Weight gain	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Weight loss	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0002 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
White blood cell decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Acidosis	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected7 at risk EG0013 affected9 at risk EG0024 affected6 at risk EG003
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected7 at risk EG0013 affected9 at risk EG0020 affected6 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hypernatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Hypertriglyceridemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hyperuricemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected7 at risk EG0012 affected9 at risk EG0021 affected6 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0012 affected9 at risk EG0020 affected6 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0002 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0022 affected6 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected7 at risk EG0017 affected9 at risk EG0023 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Avascular necrosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Muscle weakness left-sided	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Muscle weakness right-sided	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Muscle weakness upper limb	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Musculoskeletal and connective tissue disorder - Other	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected9 at risk EG0020 affected6 at risk EG003
Acoustic nerve disorder NOS	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Ataxia	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Central nervous system necrosis	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Cognitive disturbance	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Depressed level of consciousness	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Dizziness	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected9 at risk EG0021 affected6 at risk EG003
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected7 at risk EG0012 affected9 at risk EG0023 affected6 at risk EG003
Dysphasia	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0012 affected9 at risk EG0022 affected6 at risk EG003
Extrapyramidal disorder	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Facial nerve disorder	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Headache	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected7 at risk EG0012 affected9 at risk EG0022 affected6 at risk EG003
Hydrocephalus	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Leukoencephalopathy	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Memory impairment	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Nervous system disorders - Other	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Neuralgia	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0002 affected7 at risk EG0012 affected9 at risk EG0021 affected6 at risk EG003
Oculomotor nerve disorder	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected7 at risk EG0012 affected9 at risk EG0022 affected6 at risk EG003
Seizure	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0013 affected9 at risk EG0022 affected6 at risk EG003
Sinus pain	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Syncope	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Tremor	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Agitation	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0022 affected6 at risk EG003
Anxiety	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Confusion	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0023 affected6 at risk EG003
Depression	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Insomnia	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0012 affected9 at risk EG0021 affected6 at risk EG003
Libido decreased	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Personality change	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Chronic kidney disease	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Urinary frequency	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Urinary incontinence	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Urinary tract pain	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Urine discoloration	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected7 at risk EG0013 affected9 at risk EG0022 affected6 at risk EG003
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Apnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0020 affected6 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Respiratory, thoracic and mediastinal disorders - Other	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Sinus disorder	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Voice alteration	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected7 at risk EG0015 affected9 at risk EG0024 affected6 at risk EG003
Body odor	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Nail loss	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected7 at risk EG0012 affected9 at risk EG0022 affected6 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected7 at risk EG0013 affected9 at risk EG0023 affected6 at risk EG003
Photosensitivity	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected9 at risk EG0021 affected6 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Rash acneiform	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0022 affected6 at risk EG003
Skin and subcutaneous tissue disorders - Other	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected9 at risk EG0022 affected6 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected7 at risk EG0015 affected9 at risk EG0022 affected6 at risk EG003
Skin ulceration	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Flushing	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0022 affected6 at risk EG003
Hematoma	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hot flashes	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Hypertension	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003
Hypotension	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected9 at risk EG0021 affected6 at risk EG003
Phlebitis	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0020 affected6 at risk EG003
Thromboembolic event	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected7 at risk EG0013 affected9 at risk EG0020 affected6 at risk EG003
Vascular disorders - Other	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected9 at risk EG0021 affected6 at risk EG003

ID	Term
D005909	Glioblastoma
D018316	Gliosarcoma

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue

ID	Term
D020266	Radiotherapy, Conformal
C437683	motexafin gadolinium
D000077204	Temozolomide

ID	Term
D011881	Radiotherapy, Computer-Assisted
D011878	Radiotherapy
D013812	Therapeutics
D003606	Dacarbazine
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds