Patients With Metastatic Colorectal Cancer Treated With R... | NCT01103323

NCT01103323

ID	Type	Description	Link
2009-012787-14	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regorafenib (Stivarga, BAY73-4506)+BSC	Experimental	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care(BSC).	Drug: Regorafenib (Stivarga, BAY73-4506) Other: Best Supportive Care (BSC)
Placebo+BSC	Placebo Comparator	Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care (BSC).	Drug: Placebo Other: Best Supportive Care (BSC)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regorafenib (Stivarga, BAY73-4506)	Drug	160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)	Regorafenib (Stivarga, BAY73-4506)+BSC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.	From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (Based on Investigator's Assessment)	Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented.	From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Beverly Hills	California	90211	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23177514	Result	Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.
22421192

Label	URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Regorafenib (Stivarga, BAY73-4506)+BSC	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
FG001	Placebo+BSC

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). Period 1 is placebo and placebo-regorafenib with placebo period only before unblinding. Period 2 is placebo-regorafenib with regorafenib period only.

Arm/Group Information

ID	Title	Description
BG000	Regorafenib (Stivarga, BAY73-4506)+BSC	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
BG001	Placebo+BSC	Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

The age of the patient in years at enrollment in the study.

Mean

Full Range

Years

Title

Denominators

Categories

Title	Measurements
	BG00060.7(22 to 82) BG00160.1(25 to 85) BG00260.5(22 to 85)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000194 BG001102 BG002

Eastern Cooperative Oncology Group (ECOG) performance status (PS) before treatment

ECOG PS is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). 0=Fully active without restriction; 1= Restricted in physically strenuous activity; 2= Ambulatory, capable of all selfcare; 3= Capable of limited selfcare; 4= Completely disabled; 5= Dead

Number

Participants

Title

Denominators

Categories

Title	Measurements
	BG000265 BG001

KRAS mutation

KRAS - Kirsten rat sarcoma viral oncogene homolog (protein), member of the RAS family of GTPases (guanosine triphosphate hydrolases)

Number

Participants

Title

Denominators

Categories

Title	Measurements
	BG000205 BG00194 BG002

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

Overall Survival

Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.

Intent to treat (ITT)

Posted

Median

95% Confidence Interval

Days

From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).

ID	Title	Description
OG000	Regorafenib (Stivarga, BAY73-4506)+BSC	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
OG001	Placebo+BSC	Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)

Units	Counts
Participants	OG000505 OG001255

Title

Denominators

Categories

Title	Measurements
	OG000196(178 to 222) OG001151(134 to 177)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Sample size based on primary efficacy endpoint of OS. The study was designed to have 90% power to detect 33.3% increase in median OS (i.e. hazard ratio of 0.75, Regorafenib / Placebo). Assuming 1-sided overall alpha of 0.025, randomization ratio of 2:1 for Regorafenib and Placebo, and 2 formal interim analyses of OS using an O'Brien-Fleming-type error spending function, a total of 582 death events were required for primary completion. Results based on 2nd planned formal IA with 432 total events.	Log Rank		0.005178	According to protocol specified O'Brien-Fleming type alpha spending function and 432 death events at 2nd IA, the pre-specified alpha (false positive rate) for this analysis was 0.009279 (1-sided).	Hazard Ratio (HR)	0.774				95	0.636	0.942

Secondary

Progression-free Survival (Based on Investigator's Assessment)

Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented.

ITT

Posted

Median

95% Confidence Interval

Days

From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.

ID	Title	Description
OG000	Regorafenib (Stivarga, BAY73-4506)+BSC	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
OG001	Placebo+BSC	Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)

Units	Counts
Participants

Secondary

Objective Tumor Response

The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis.

ITT

Posted

Number

Percentage of participants

ID	Title	Description
OG000	Regorafenib (Stivarga, BAY73-4506)+BSC	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
OG001	Placebo+BSC	Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)

Units	Counts

Secondary

Disease Control

Disease control was defined as the percentage of patients whose best response was not PD [sum of lesion sizes increased at least 20% from smallest sum on study or new lesions] (ie, CR [tumor disappears], PR [sum of lesion sizes decreased at least 30% from baseline] or SD (stable disease)). SD included if at least 6 weeks after randomization.

ITT

Posted

Number

Percentage of participants

ID	Title	Description
OG000	Regorafenib (Stivarga, BAY73-4506)+BSC	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
OG001	Placebo+BSC	Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)

Units	Counts
Participants

Secondary

Tumor Response

A tumor response (best overall response) was defined for all patients, using the RECIST criteria, version 1.1. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased at least 30% from baseline), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions). Clinical PD considered when radiographic imaging not possible.

ITT

Posted

Number

Percentage of participants

ID	Title	Description
OG000	Regorafenib (Stivarga, BAY73-4506)+BSC	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
OG001	Placebo+BSC	Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Regorafenib (BAY73-4506)+BSC	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).	232	500	489	500
EG001	Placebo+BSC	Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). It is for placebo period only before unblinding.	103	253	229	253
EG002	Placebo - Regorafenib After Unblinding	Participants in the placebo+BSC group switched to treatment with Regorafenib after unblinding. It is for Regorafenib treatment period only	2	4	4	4

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DIC	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Edema: Limb	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Edema: Trunk/Genital	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0014 events2 affected253 at risk EG0020 events0 affected4 at risk
Edema: Viscera	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0013 events1 affected253 at risk EG0020 events0 affected4 at risk
Hemoglobin	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0008 events4 affected500 at risk EG0012 events2 affected253 at risk EG0020 events0 affected4 at risk
INR	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0005 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Neutrophils	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Platelets	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Cardiac arrhythmia - Other	Cardiac disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Cardiac ischemia/infarction	Cardiac disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0006 events6 affected500 at risk EG0012 events1 affected253 at risk EG0020 events0 affected4 at risk
Hypertension	Cardiac disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hypotension	Cardiac disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Left ventricular systolic dysfunction	Cardiac disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0003 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Supraventricular arrhythmia, Atrial fibrillation	Cardiac disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
cTnT	Cardiac disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Diplopia	Eye disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Ocular - Other	Eye disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Anorexia	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0008 events5 affected500 at risk EG0012 events2 affected253 at risk EG0020 events0 affected4 at risk
Ascites	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0012 events2 affected253 at risk EG0021 events1 affected4 at risk
Constipation	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Dehydration	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0003 events3 affected500 at risk EG0012 events2 affected253 at risk EG0020 events0 affected4 at risk
Diarrhea	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0009 events8 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Distension	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Enteritis	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Fistula, GI, Abdomen NOS	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Fistula, GI, Anus	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Fistula, GI, Small bowel NOS	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
GI - Other	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhoids	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Ileus	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0003 events2 affected500 at risk EG0013 events3 affected253 at risk EG0020 events0 affected4 at risk
Mucositis (functional/symptomatic), Small bowel	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Necrosis, GI, Peritoneal cavity	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Obstruction, GI, Colon	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00011 events9 affected500 at risk EG0018 events6 affected253 at risk EG0020 events0 affected4 at risk
Obstruction, GI, Ileum	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Obstruction, GI, Small bowel NOS	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0005 events4 affected500 at risk EG0019 events7 affected253 at risk EG0020 events0 affected4 at risk
Obstruction, GI, Stomach	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Perforation, GI, Colon	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Stricture, GI, Biliary tree	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Ulcer, GI, Duodenum	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Vomiting	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0003 events3 affected500 at risk EG0010 events0 affected253 at risk EG0021 events1 affected4 at risk
Constitutional symptoms - Other	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00049 events34 affected500 at risk EG00139 events23 affected253 at risk EG0020 events0 affected4 at risk
Death not associated with CTCAE term, Disease progression NOS	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00017 events16 affected500 at risk EG0016 events6 affected253 at risk EG0021 events1 affected4 at risk
Death not associated with CTCAE term, Multi-Organ Failure	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0004 events4 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Death not associated with CTCAE term, Sudden death	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0012 events2 affected253 at risk EG0020 events0 affected4 at risk
Fatigue	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0006 events5 affected500 at risk EG0015 events5 affected253 at risk EG0020 events0 affected4 at risk
Fever	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00021 events17 affected500 at risk EG0012 events2 affected253 at risk EG0020 events0 affected4 at risk
Pain, Abdomen NOS	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00021 events13 affected500 at risk EG0012 events2 affected253 at risk EG0020 events0 affected4 at risk
Pain, Back	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0006 events4 affected500 at risk EG0015 events4 affected253 at risk EG0020 events0 affected4 at risk
Pain, Buttock	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0004 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Pain, Cardiac/Heart	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Pain, Chest wall	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Pain, Chest/Thorax NOS	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0004 events4 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Pain, Extremity - limb	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0006 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Pain, Head/Headache	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Pain, Joint	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Pain, Liver	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Pain, Neuralgia/Peripheral nerve	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Pain, Pain NOS	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Pain, Tumor pain	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0003 events3 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Syndromes - Other	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Tumor flare	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Weight loss	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Cholecystitis	Hepatobiliary disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hepatobiliary - Other	Hepatobiliary disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Liver dysfunction	Hepatobiliary disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00028 events17 affected500 at risk EG00111 events5 affected253 at risk EG0020 events0 affected4 at risk
Allergic reaction	Immune system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0004 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Abdomen NOS	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0004 events4 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Anal/perianal	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Appendix	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Bladder (urinary)	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Blood	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0005 events3 affected500 at risk EG0012 events2 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Bronchus	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0003 events3 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Catheter-related	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Kidney	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Lung (Pneumonia)	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00011 events9 affected500 at risk EG0014 events3 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Skin (Cellulitis)	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Soft tissue NOS	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Urinary tract NOS	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection (documented clinically), Wound	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection - Other	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0006 events5 affected500 at risk EG0012 events1 affected253 at risk EG0020 events0 affected4 at risk
Infection with normal ANC, Blood	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Infection with normal ANC, Catheter-related	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection with normal ANC, Colon	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection with normal ANC, Gallbladder (Cholecystitis)	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection with normal ANC, Kidney	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection with normal ANC, Lung (Pneumonia)	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Infection with normal ANC, Soft tissue NOS	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection with unknown ANC, Kidney	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Infection with unknown ANC, Lung (Pneumonia)	Infections and infestations	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
AST	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Bilirubin (Hyperbilirubinemia)	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00011 events8 affected500 at risk EG0013 events3 affected253 at risk EG0020 events0 affected4 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hypocalcemia	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hyponatremia	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Metabolic/Lab - Other	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Fracture	Musculoskeletal and connective tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0004 events4 affected500 at risk EG0013 events2 affected253 at risk EG0020 events0 affected4 at risk
Gait/Walking	Musculoskeletal and connective tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Muscle weakness left-sided	Musculoskeletal and connective tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Muscle weakness, Extremity - lower	Musculoskeletal and connective tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Muscle weakness, Whole body/generalized	Musculoskeletal and connective tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Musculoskeletal - Other	Musculoskeletal and connective tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Myositis	Musculoskeletal and connective tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Secondary malignancy (possibly related to cancer treatment)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Ataxia	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
CNS ischemia	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0012 events2 affected253 at risk EG0020 events0 affected4 at risk
Cognitive disturbance	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Confusion	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Dizziness	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Encephalopathy	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Mood Alteration, Anxiety	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Neurology - Other	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0004 events3 affected500 at risk EG0012 events2 affected253 at risk EG0020 events0 affected4 at risk
Neuropathy: Cranial, CN III Pupil, upper eyelid, extra ocular mov	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Neuropathy: motor	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0003 events3 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Seizure	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Somnolence	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Speech impairment	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Syncope (Fainting)	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Cystitis	Renal and urinary disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Fistula, GU, Bladder	Renal and urinary disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Obstruction, GU, Ureter	Renal and urinary disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Renal - Other	Renal and urinary disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Renal failure	Renal and urinary disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0006 events5 affected500 at risk EG0015 events3 affected253 at risk EG0020 events0 affected4 at risk
Urinary retention	Renal and urinary disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0012 events2 affected253 at risk EG0020 events0 affected4 at risk
ARDS	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Cough	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Dyspnea (Shortness of breath)	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00018 events12 affected500 at risk EG0014 events4 affected253 at risk EG0020 events0 affected4 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0014 events4 affected253 at risk EG0020 events0 affected4 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0003 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Pulmonary - Other	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Dermatology - Other	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0013 events2 affected253 at risk EG0020 events0 affected4 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hand-foot skin reaction	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0003 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Rash/Desquamation	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0007 events4 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Wound complication, non-infectious	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Hematoma	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage - Other	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage pulmonary, Bronchus	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage pulmonary, Mediastinum	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage, GI, Abdomen NOS	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0004 events2 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage, GI, Anus	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage, GI, Lower GI NOS	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage, GI, Rectum	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage, GI, Stoma	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage, GI, Upper GI NOS	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage, GI, Varices (esophageal)	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage, GI, Varices (rectal)	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Hemorrhage, GU, Vagina	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk
Thrombosis/Embolism (vascular access)	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Thrombosis/Thrombus/Embolism	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0006 events6 affected500 at risk EG0015 events3 affected253 at risk EG0020 events0 affected4 at risk
Vascular - Other	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0002 events1 affected500 at risk EG0010 events0 affected253 at risk EG0020 events0 affected4 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Edema: Limb	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00057 events49 affected500 at risk EG00119 events16 affected253 at risk EG0020 events0 affected4 at risk
Hemoglobin	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000142 events76 affected500 at risk EG00146 events29 affected253 at risk EG0020 events0 affected4 at risk
Platelets	Blood and lymphatic system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000136 events79 affected500 at risk EG0019 events6 affected253 at risk EG0022 events1 affected4 at risk
Hypertension	Cardiac disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000213 events155 affected500 at risk EG00123 events21 affected253 at risk EG0021 events1 affected4 at risk
Hypothyroidism	Endocrine disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00029 events27 affected500 at risk EG0011 events1 affected253 at risk EG0021 events1 affected4 at risk
Ocular - Other	Eye disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0005 events5 affected500 at risk EG0010 events0 affected253 at risk EG0021 events1 affected4 at risk
Anorexia	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000388 events239 affected500 at risk EG00196 events73 affected253 at risk EG0020 events0 affected4 at risk
Ascites	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00024 events23 affected500 at risk EG0018 events6 affected253 at risk EG0021 events1 affected4 at risk
Constipation	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000147 events119 affected500 at risk EG00158 events48 affected253 at risk EG0020 events0 affected4 at risk
Diarrhea	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000514 events218 affected500 at risk EG00157 events44 affected253 at risk EG0022 events2 affected4 at risk
Fistula, GI, Colon/Cecum/Appendix	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected253 at risk EG0021 events1 affected4 at risk
Mucositis (functional/symptomatic), Oral cavity	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000267 events145 affected500 at risk EG00112 events12 affected253 at risk EG0020 events0 affected4 at risk
Nausea	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000162 events115 affected500 at risk EG00167 events55 affected253 at risk EG0021 events1 affected4 at risk
Taste alteration	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00044 events39 affected500 at risk EG0016 events6 affected253 at risk EG0020 events0 affected4 at risk
Vomiting	Gastrointestinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000144 events85 affected500 at risk EG00150 events41 affected253 at risk EG0023 events1 affected4 at risk
Constitutional symptoms - Other	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00033 events30 affected500 at risk EG00119 events17 affected253 at risk EG0020 events0 affected4 at risk
Fatigue	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000612 events318 affected500 at risk EG001168 events115 affected253 at risk EG0020 events0 affected4 at risk
Fever	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000189 events136 affected500 at risk EG00148 events40 affected253 at risk EG0023 events2 affected4 at risk
Flu-like syndrome	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00030 events27 affected500 at risk EG0018 events6 affected253 at risk EG0021 events1 affected4 at risk
Insomnia	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00043 events39 affected500 at risk EG00115 events14 affected253 at risk EG0020 events0 affected4 at risk
Pain, Abdomen NOS	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000239 events121 affected500 at risk EG00153 events47 affected253 at risk EG0020 events0 affected4 at risk
Pain, Back	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000114 events79 affected500 at risk EG00127 events25 affected253 at risk EG0020 events0 affected4 at risk
Pain, Buttock	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0005 events4 affected500 at risk EG0010 events0 affected253 at risk EG0021 events1 affected4 at risk
Pain, Chest/Thorax NOS	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00029 events26 affected500 at risk EG00114 events12 affected253 at risk EG0020 events0 affected4 at risk
Pain, Extremity - limb	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00083 events51 affected500 at risk EG00119 events14 affected253 at risk EG0020 events0 affected4 at risk
Pain, Head/Headache	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00065 events50 affected500 at risk EG00123 events18 affected253 at risk EG0020 events0 affected4 at risk
Pain, Joint	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00034 events32 affected500 at risk EG00114 events13 affected253 at risk EG0020 events0 affected4 at risk
Pain, Muscle	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00064 events50 affected500 at risk EG00116 events14 affected253 at risk EG0020 events0 affected4 at risk
Pain, Throat/Pharynx/Larynx	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00012 events9 affected500 at risk EG0011 events1 affected253 at risk EG0021 events1 affected4 at risk
Weight loss	General disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000240 events167 affected500 at risk EG00134 events30 affected253 at risk EG0027 events2 affected4 at risk
Hepatobiliary - Other	Hepatobiliary disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0009 events8 affected500 at risk EG0014 events4 affected253 at risk EG0023 events1 affected4 at risk
ALT	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00053 events28 affected500 at risk EG0018 events7 affected253 at risk EG0020 events0 affected4 at risk
AST	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00072 events37 affected500 at risk EG00113 events12 affected253 at risk EG0020 events0 affected4 at risk
Alkaline phosphatase	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00049 events35 affected500 at risk EG00112 events8 affected253 at risk EG0020 events0 affected4 at risk
Bilirubin (Hyperbilirubinemia)	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000160 events97 affected500 at risk EG00137 events22 affected253 at risk EG0023 events1 affected4 at risk
Creatinine	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00019 events15 affected500 at risk EG0018 events7 affected253 at risk EG0022 events1 affected4 at risk
GFR	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0009 events4 affected500 at risk EG0012 events1 affected253 at risk EG0021 events1 affected4 at risk
Hyperuricemia	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00013 events12 affected500 at risk EG0011 events1 affected253 at risk EG0021 events1 affected4 at risk
Hypocalcemia	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00057 events34 affected500 at risk EG0011 events1 affected253 at risk EG0020 events0 affected4 at risk
Hypokalemia	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00084 events50 affected500 at risk EG0017 events6 affected253 at risk EG0020 events0 affected4 at risk
Hyponatremia	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00043 events32 affected500 at risk EG00110 events6 affected253 at risk EG0020 events0 affected4 at risk
Hypophosphatemia	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00062 events32 affected500 at risk EG0013 events2 affected253 at risk EG0022 events1 affected4 at risk
Lipase	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00074 events32 affected500 at risk EG0014 events3 affected253 at risk EG0020 events0 affected4 at risk
Metabolic/Lab - Other	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00069 events42 affected500 at risk EG00115 events8 affected253 at risk EG0020 events0 affected4 at risk
Proteinuria	Metabolism and nutrition disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000109 events40 affected500 at risk EG00111 events6 affected253 at risk EG0020 events0 affected4 at risk
Dizziness	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00031 events28 affected500 at risk EG00113 events13 affected253 at risk EG0020 events0 affected4 at risk
Neuropathy: sensory	Nervous system disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00068 events51 affected500 at risk EG00127 events25 affected253 at risk EG0020 events0 affected4 at risk
Cough	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00077 events56 affected500 at risk EG00132 events28 affected253 at risk EG0021 events1 affected4 at risk
Dyspnea (Shortness of breath)	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000110 events89 affected500 at risk EG00146 events34 affected253 at risk EG0020 events0 affected4 at risk
Voice changes	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000211 events160 affected500 at risk EG00117 events16 affected253 at risk EG0021 events1 affected4 at risk
Alopecia	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00043 events39 affected500 at risk EG0014 events4 affected253 at risk EG0020 events0 affected4 at risk
Cheilitis	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG0004 events4 affected500 at risk EG0010 events0 affected253 at risk EG0023 events1 affected4 at risk
Dermatology - Other	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00045 events30 affected500 at risk EG00110 events7 affected253 at risk EG0020 events0 affected4 at risk
Dry skin	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00059 events50 affected500 at risk EG00111 events10 affected253 at risk EG0020 events0 affected4 at risk
Hand-foot skin reaction	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000720 events235 affected500 at risk EG00121 events19 affected253 at risk EG0023 events1 affected4 at risk
Pruritus	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00039 events29 affected500 at risk EG00111 events11 affected253 at risk EG0020 events0 affected4 at risk
Rash/Desquamation	Skin and subcutaneous tissue disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG000211 events145 affected500 at risk EG00117 events13 affected253 at risk EG0022 events1 affected4 at risk
Hemorrhage pulmonary, Nose	Vascular disorders	NCI-CTCAE v.3.0	Non-systematic Assessment	EG00055 events45 affected500 at risk EG0016 events6 affected253 at risk EG0020 events0 affected4 at risk

Certain Agreements

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases