A Phase III Study of Sorafenib in Patients With Advanced... | NCT00105443

NCT00105443

ID	Type	Description	Link
2004-001773-26	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
Sorafenib (Nexavar, BAY43-9006)	Experimental	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.	Drug: Sorafenib (Nexavar, BAY43-9006)
Placebo	Placebo Comparator	Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib (Nexavar, BAY43-9006)	Drug	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.	from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment
Time to Symptomatic Progression (TTSP)	TTSP was defined as the time from randomization to the first documented symptomatic progression.	from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment

Secondary Outcomes

Measure	Description	Time Frame
Time to Progression (TTP)	TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.	from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona	85054-4502	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18650514	Result	Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
40388796

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	A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
BG001	Placebo	Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
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

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00064.9± 11.2 BG00166.3± 10.2 BG00265.6± 10.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00039 BG00139 BG002

Baseline Eastern Cooperative Oncology Group (ECOG)

Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). Subjects entering this study were to have an ECOG score of 0, 1 or 2.

Number

participants

Title

Denominators

Categories

0 = fully active

Title	Measurements
	BG000161 BG001

Tumor burden

Tumor burden refers to the number of cancer cells, the size of a tumor, or the amount of cancer in the body and is also called the tumor load. Randomization was stratified by "tumor burden" assessment, ie, the presence of either macroscopic vascular invasion as determined by radiological assessment and/or extra-hepatic spread versus none.

Number

participants

Title

Denominators

Categories

Absent

Title	Measurements
	BG00090 BG001

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 (OS)

Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 17 Oct 2006.

Posted

Median

95% Confidence Interval

days

from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment

ID	Title	Description
OG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
OG001	Placebo	Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

Units	Counts
Participants	OG000299 OG001303

Title

Denominators

Categories

Title	Measurements
	OG000324(286 to 405) OG001241(206 to 276)

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	The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.02 stratified by region, ECOG PS and "tumor burden". In addition to the final analysis at the end of the study, 2 formal interim analyses of overall survival were planned. An alpha spending function was used to ensure that the false positive rate is less than or equal to 0.02 (1-sided). The study was stopped at the second interim analysis, the results of which are reported here.	Log Rank		0.00583	According to the pre-specified O'Brien-Fleming alpha spending function, the alpha value for this second interim analysis was 0.0073 (corresponding to a nominal value of 0.0077 after taking into account the first interim analysis).	Hazard Ratio (HR)	0.6931				95	0.5549	0.8658

Primary

Time to Symptomatic Progression (TTSP)

TTSP was defined as the time from randomization to the first documented symptomatic progression.

This analysis was for the ITT population. For subjects who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of their last Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) questionnaire assessment.

Posted

Median

95% Confidence Interval

days

from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment

ID	Title	Description
OG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
OG001	Placebo	Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

Secondary

Time to Progression (TTP)

TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.

The primary analysis of TTP for the ITT population was based on the independent radiological review for the interim analysis. The cut-off date chosen for the analysis of radiological progression events was 12 May 2006

Posted

Median

95% Confidence Interval

days

from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment

ID	Title	Description
OG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
OG001	Placebo	Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

Secondary

Disease Control (DC)

The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.

In this study, the DC for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors [RECIST])

Posted

Number

Participants

time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment

ID	Title	Description
OG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
OG001	Placebo	Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

Secondary

Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire

PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.

In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline <8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006

Posted

Number

Participants

from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment

ID	Title	Description
OG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
OG001	Placebo

Post-Hoc

Overall Survival

Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

The OS data (ITT population) are descriptive only (no p-values) from the date of randomization to the date of death due to any cause. For patients alive at the time of analysis, time to death was censored at the date of last follow-up or at the data cutoff date of 09 Feb 2007 when subjects were given the option to crossover to sorafenib treatment

Posted

Median

95% Confidence Interval

Days

from randomization to death due to any cause until an average 8.5 months later up to the data cut-off date approximately 23 months after start of enrollment

ID	Title	Description
OG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
OG001	Placebo	Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

Post-Hoc

Time to Symptomatic Progression (TTSP)

TTSP was defined as the time from randomization to the first documented symptomatic progression

For subjects (in the ITT population) who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of last FACT FHSI-8 questionnaire assessment (upon an interim review by the Data Monitoring Committee on 09 Feb 2007), when the study was considered positive for its primary endpoint, OS, and was stopped early.

Posted

Median

95% Confidence Interval

Days

from randomization to the first documented symptomatic progression until an average 5.7 months later up to the data cut-off date approximately 23 months after start of enrollment

ID	Title	Description
OG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
OG001	Placebo	Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

Post-Hoc

Time to Progression (TTP)

The independent radiological review as initially scheduled for the interim analysis did not continue after 12 May 2006. The primary analysis of TTP for the ITT population after 12 May 2006 up to the cutoff date of 09 Feb 2007 was based on the Investigator radiological assessments

Posted

Median

95% Confidence Interval

Days

from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 23 months after start of enrollment

ID	Title	Description
OG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
OG001	Placebo	Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

Post-Hoc

Disease Control (DC)

The DC is defined as the number of subjects with a best response rating of CR, PR, or SD that is maintained at least 28 days from the first manifestation of that rating.

The disease control rate for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors (RECIST) up to the cutoff date of 09 Feb 2007

Posted

Number

Participants

from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment

ID	Title	Description
OG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
OG001	Placebo	Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

Post-Hoc

Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire

In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 Day 1 or, for those discontinuing prior to that visit, at the end of study. It was summarized as number of patients with change from baseline <8 to ≥8 points for each treatment group up to the cutoff date of 09 Feb 2007.

Posted

Number

Participants

from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment

ID	Title	Description
OG000	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
OG001

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sorafenib (Nexavar) Arm Double-Blind Phase (Interim Data Only)	Reporting Group 1 (RG 1): All participants in Double-Blind phase randomized to Sorafenib treatment (data before Oct 17, 2006); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.	153	297	275	297
EG001	Placebo Arm Double-Blind Phase (Interim Data Only)	Reporting Group 2 (RG 2): All participants in Double-Blind phase randomized to Sorafenib-matching placebo (data before Oct 17, 2006); Sorafenib-matching placebo tablets were orally administered twice daily (bid). Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section.	164	302	259	302
EG002	Sorafenib (Nexavar) Arm Complete (Incl. Open Label Phase)	Reporting Group 3 (RG 3): All participants that initially were randomized to Sorafenib treatment (data before unblinding (= Double-Blind phase) and after unblinding (= Open Label phase)), until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.	191	297	281	297
EG003	Placebo Arm, Complete Double-Blind Phase	Reporting Group 4 (RG 4): All participants that initially were randomized to Placebo (data from Placebo patients before unblinding at Feb 09, 2007); Sorafenib-matching placebo tablets were orally administered twice daily (bid). Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section.	185	302	271	302
EG004	Subjects Switching From Placebo to Sorafenib (Open Label Only)	Reporting Group 5 (RG 5): Participants initially randomized to Placebo who switched to Sorafenib in Open Label phase (data after unblinding only, from Feb 09, 2007 until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid). Note: Safety Data presented here include participants listed in Arm B2 of the Participant Flow section.	26	47	43	47

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
neutrophils	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG0030 affected302 at risk EG0040 affected47 at risk
hemoglobin	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0008 affected297 at risk EG0016 affected302 at risk EG00211 affected297 at risk EG003
leukocytes	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
supraventricular arrhythmia, atrial fibrillation	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected302 at risk EG0021 affected297 at risk EG003
conduction abnormality, av block - first degree	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
supraventricular arrhythmia, sinus tachycardia	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
ventricular arrhythmia, ventricular fibrillation	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
ventricular arrhythmia, ventricular tachycardia	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
inr	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0022 affected297 at risk EG003
left ventricular diastolic dysfunction	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected302 at risk EG0022 affected297 at risk EG003
hypertension	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected302 at risk EG0021 affected297 at risk EG003
cardiac ischemia/infarction	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0008 affected297 at risk EG0014 affected302 at risk EG0029 affected297 at risk EG003
hypotension	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected302 at risk EG0021 affected297 at risk EG003
cardiac general - other	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0013 affected302 at risk EG0020 affected297 at risk EG003
right ventricular dysfunction	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
left ventricular systolic dysfunction	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected302 at risk EG0022 affected297 at risk EG003
death not associated with ctcae term, death nos	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0014 affected302 at risk EG0021 affected297 at risk EG003
death not associated with ctcae term, disease progression nos	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00056 affected297 at risk EG00161 affected302 at risk EG00268 affected297 at risk EG003
death not associated with ctcae term, multi-organ failure	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0024 affected297 at risk EG003
death not associated with ctcae term, sudden death	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0021 affected297 at risk EG003
hyperthyroidism	Endocrine disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
fever	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0014 affected302 at risk EG0024 affected297 at risk EG003
insomnia	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
fatigue	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0005 affected297 at risk EG0019 affected302 at risk EG0027 affected297 at risk EG003
weight loss	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0013 affected302 at risk EG0020 affected297 at risk EG003
constitutional symptoms - other	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0016 affected302 at risk EG0026 affected297 at risk EG003
anorexia	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0011 affected302 at risk EG0023 affected297 at risk EG003
ascites	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00014 affected297 at risk EG00113 affected302 at risk EG00216 affected297 at risk EG003
colitis	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
constipation	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
dehydration	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0009 affected297 at risk EG0011 affected302 at risk EG00210 affected297 at risk EG003
diarrhea	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00014 affected297 at risk EG0015 affected302 at risk EG00216 affected297 at risk EG003
dysphagia	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
enteritis	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
gastritis	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
nausea	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0014 affected302 at risk EG0020 affected297 at risk EG003
gi - other	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0004 affected297 at risk EG0010 affected302 at risk EG0026 affected297 at risk EG003
perforation, gi, colon	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
stricture, gi, biliary tree	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0021 affected297 at risk EG003
ulcer, gi, duodenum	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
ulcer, gi, stomach	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0022 affected297 at risk EG003
vomiting	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0005 affected297 at risk EG0014 affected302 at risk EG0025 affected297 at risk EG003
cns hemorrhage	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0011 affected302 at risk EG0022 affected297 at risk EG003
hematoma	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
hemorrhage, gi, abdomen nos	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0013 affected302 at risk EG0022 affected297 at risk EG003
hemorrhage, gi, colon	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
hemorrhage, gi, duodenum	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected302 at risk EG0021 affected297 at risk EG003
hemorrhage, gi, esophagus	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0013 affected302 at risk EG0024 affected297 at risk EG003
hemorrhage, gi, varices (esophageal)	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0007 affected297 at risk EG00111 affected302 at risk EG0028 affected297 at risk EG003
hemorrhage, gi, stomach	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0004 affected297 at risk EG0012 affected302 at risk EG0025 affected297 at risk EG003
hemorrhage, gi, liver	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0004 affected297 at risk EG0011 affected302 at risk EG0026 affected297 at risk EG003
hemorrhage, gi, lower gi nos	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
hemorrhage, gi, oral cavity	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
hemorrhage, gi, peritoneal cavity	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0016 affected302 at risk EG0022 affected297 at risk EG003
hemorrhage, gi, varices (rectal)	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
hemorrhage, gi, upper gi nos	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0016 affected302 at risk EG0025 affected297 at risk EG003
hemorrhage with surgery	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
hemorrhage - other	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected302 at risk EG0022 affected297 at risk EG003
hemorrhage pulmonary, lung	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
hemorrhage pulmonary, pleura	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
cholecystitis	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0023 affected297 at risk EG003
liver dysfunction	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00021 affected297 at risk EG00114 affected302 at risk EG00221 affected297 at risk EG003
hepatobiliary - other	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00011 affected297 at risk EG00116 affected302 at risk EG00216 affected297 at risk EG003
pancreatitis	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection (documented clinically), abdomen nos	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection (documented clinically), anal/perianal	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection (documented clinically), biliary tree	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
infection (documented clinically), lung (pneumonia)	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0013 affected302 at risk EG0026 affected297 at risk EG003
infection (documented clinically), skin (cellulitis)	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected302 at risk EG0021 affected297 at risk EG003
infection (documented clinically), soft tissue nos	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
infection (documented clinically), upper airway nos	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection (documented clinically), urinary tract nos	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0010 affected302 at risk EG0023 affected297 at risk EG003
infection with normal anc, bronchus	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
infection with normal anc, gallbladder (cholecystitis)	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection with normal anc, oral cavity-gums (gingivitis)	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
infection with normal anc, peritoneal cavity	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0012 affected302 at risk EG0020 affected297 at risk EG003
infection with normal anc, skin (cellulitis)	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
infection with normal anc, urinary tract nos	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
infection - other	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0013 affected302 at risk EG0022 affected297 at risk EG003
infection with unknown anc, biliary tree	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection with unknown anc, lung (pneumonia)	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0013 affected302 at risk EG0020 affected297 at risk EG003
infection with unknown anc, peritoneal cavity	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected302 at risk EG0021 affected297 at risk EG003
infection with unknown anc, urinary tract nos	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
infection with unknown anc, wound	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
edema: limb	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected302 at risk EG0022 affected297 at risk EG003
lymphatics - other	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
fracture	Musculoskeletal and connective tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0004 affected297 at risk EG0013 affected302 at risk EG0025 affected297 at risk EG003
musculoskeletal - other	Musculoskeletal and connective tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0013 affected302 at risk EG0023 affected297 at risk EG003
device/prosthesis	Musculoskeletal and connective tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
muscle weakness, whole body/generalized	Musculoskeletal and connective tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
ALT	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0012 affected302 at risk EG0020 affected297 at risk EG003
AST	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected302 at risk EG0021 affected297 at risk EG003
cpk	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
creatinine	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
ggt	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
bilirubin (hyperbilirubinemia)	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0006 affected297 at risk EG0014 affected302 at risk EG0026 affected297 at risk EG003
hypercalcemia	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected302 at risk EG0022 affected297 at risk EG003
hyperglycemia	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected302 at risk EG0021 affected297 at risk EG003
hyperkalemia	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
hypoalbuminemia	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
hypoglycemia	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0005 affected297 at risk EG0013 affected302 at risk EG0025 affected297 at risk EG003
hypomagnesemia	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
hyponatremia	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
cns ischemia	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0014 affected302 at risk EG0021 affected297 at risk EG003
confusion	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected302 at risk EG0021 affected297 at risk EG003
dizziness	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
encephalopathy	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0012 affected302 at risk EG0024 affected297 at risk EG003
mood alteration, depression	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
neuropathy: motor	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0013 affected302 at risk EG0021 affected297 at risk EG003
neurology - other	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0013 affected302 at risk EG0020 affected297 at risk EG003
neuropathy: sensory	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected302 at risk EG0021 affected297 at risk EG003
seizure	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected302 at risk EG0021 affected297 at risk EG003
somnolence	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0012 affected302 at risk EG0022 affected297 at risk EG003
syncope (fainting)	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected302 at risk EG0022 affected297 at risk EG003
retinal detachment	Eye disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
pain, back	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0013 affected302 at risk EG0023 affected297 at risk EG003
pain, extremity-limb	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
pain, tumor pain	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected302 at risk EG0022 affected297 at risk EG003
pain, abdomen nos	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0007 affected297 at risk EG0018 affected302 at risk EG00210 affected297 at risk EG003
pain, joint	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0010 affected302 at risk EG0023 affected297 at risk EG003
pain, bone	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0011 affected302 at risk EG0023 affected297 at risk EG003
pain, other	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
pain, liver	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0012 affected302 at risk EG0020 affected297 at risk EG003
pain, neuralgia/peripheral nerve	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
pain, stomach	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
pleural effusion	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected302 at risk EG0022 affected297 at risk EG003
hiccoughs	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
hypoxia	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
pulmonary - other	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
pneumothorax	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0012 affected302 at risk EG0023 affected297 at risk EG003
renal failure	Renal and urinary disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0018 affected302 at risk EG0022 affected297 at risk EG003
obstruction, gu, ureter	Renal and urinary disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
hand-foot skin reaction	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected302 at risk EG0022 affected297 at risk EG003
dermatology - other	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
pruritus	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
intraop injury, biliary tree - common bile duct	Injury, poisoning and procedural complications	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
syndromes - other	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
peripheral arterial ischemia	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
thrombosis/thrombus/embolism	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0003 affected297 at risk EG0013 affected302 at risk EG0027 affected297 at risk EG003
visceral arterial ischemia	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected302 at risk EG0021 affected297 at risk EG003
not coded yet	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected302 at risk EG0020 affected297 at risk EG003
conduction abnormality, asystole	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
conduction abnormality, av block-3rd degree (complete av block	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
cardiac arrhythmia - other	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
cardiopulmonary arrest	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
adrenal insufficiency	Endocrine disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
distension	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
obstruction, gi, small bowel nos	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
perforation, gi, appendix	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
hemorrhage, gi, rectum	Vascular disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection (documented clinically), blood	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection with normal anc, anal/perianal	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection with normal anc, appendix	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection with normal anc, pancreas	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection with unknown anc, appendix	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
infection with unknown anc, blood	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
infection with unknown anc, bronchus	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
lymphedema-related fibrosis	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
edema: head and neck	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
hypocalcemia	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
hypokalemia	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
cognitive disturbance	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003
pain, chest/thorax nos	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
urinary retention	Renal and urinary disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
decubitus	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
wound complication, non-infectious	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0022 affected297 at risk EG003
rash/desquamation	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
ulceration	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0020 affected297 at risk EG003
tumor flare	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0000 affected297 at risk EG0010 affected302 at risk EG0021 affected297 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
hemoglobin	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00025 affected297 at risk EG00122 affected302 at risk EG00236 affected297 at risk EG00325 affected302 at risk EG0045 affected47 at risk
hypertension	Cardiac disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00027 affected297 at risk EG00112 affected302 at risk EG00232 affected297 at risk EG003
fever	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00029 affected297 at risk EG00128 affected302 at risk EG00235 affected297 at risk EG003
insomnia	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00021 affected297 at risk EG00122 affected302 at risk EG00226 affected297 at risk EG003
fatigue	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG000133 affected297 at risk EG001132 affected302 at risk EG002145 affected297 at risk EG003
weight loss	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00089 affected297 at risk EG00128 affected302 at risk EG00293 affected297 at risk EG003
anorexia	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00083 affected297 at risk EG00152 affected302 at risk EG00289 affected297 at risk EG003
ascites	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00061 affected297 at risk EG00167 affected302 at risk EG00280 affected297 at risk EG003
constipation	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00041 affected297 at risk EG00131 affected302 at risk EG00244 affected297 at risk EG003
diarrhea	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG000158 affected297 at risk EG00174 affected302 at risk EG002166 affected297 at risk EG003
heartburn	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00015 affected297 at risk EG00110 affected302 at risk EG00216 affected297 at risk EG003
mucositis (functional/symptomatic), oral cavity	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00015 affected297 at risk EG0016 affected302 at risk EG00216 affected297 at risk EG003
mucositis (clinical exam), oral cavity	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00016 affected297 at risk EG00110 affected302 at risk EG00219 affected297 at risk EG003
nausea	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00071 affected297 at risk EG00158 affected302 at risk EG00273 affected297 at risk EG003
gi - other	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00016 affected297 at risk EG00110 affected302 at risk EG00222 affected297 at risk EG003
vomiting	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00041 affected297 at risk EG00130 affected302 at risk EG00248 affected297 at risk EG003
liver dysfunction	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00018 affected297 at risk EG0019 affected302 at risk EG00221 affected297 at risk EG003
edema: limb	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00045 affected297 at risk EG00153 affected302 at risk EG00259 affected297 at risk EG003
musculoskeletal - other	Musculoskeletal and connective tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00024 affected297 at risk EG00115 affected302 at risk EG00231 affected297 at risk EG003
AST	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0008 affected297 at risk EG00118 affected302 at risk EG0029 affected297 at risk EG003
bilirubin (hyperbilirubinemia)	Metabolism and nutrition disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00024 affected297 at risk EG00123 affected302 at risk EG00228 affected297 at risk EG003
pain, back	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00036 affected297 at risk EG00138 affected302 at risk EG00247 affected297 at risk EG003
pain, abdomen nos	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00091 affected297 at risk EG00174 affected302 at risk EG00299 affected297 at risk EG003
pain, head/headache	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00026 affected297 at risk EG00125 affected302 at risk EG00229 affected297 at risk EG003
pain, joint	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00020 affected297 at risk EG00126 affected302 at risk EG00220 affected297 at risk EG003
pain, stomach	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00021 affected297 at risk EG00120 affected302 at risk EG00223 affected297 at risk EG003
cough	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00024 affected297 at risk EG00116 affected302 at risk EG00226 affected297 at risk EG003
dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00026 affected297 at risk EG00122 affected302 at risk EG00233 affected297 at risk EG003
voice changes	Respiratory, thoracic and mediastinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00027 affected297 at risk EG0014 affected302 at risk EG00227 affected297 at risk EG003
alopecia	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00042 affected297 at risk EG0015 affected302 at risk EG00246 affected297 at risk EG003
dry skin	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00031 affected297 at risk EG00118 affected302 at risk EG00231 affected297 at risk EG003
hand-foot skin reaction	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00063 affected297 at risk EG0019 affected302 at risk EG00267 affected297 at risk EG003
dermatology - other	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00026 affected297 at risk EG00112 affected302 at risk EG00230 affected297 at risk EG003
pruritus	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00040 affected297 at risk EG00133 affected302 at risk EG00244 affected297 at risk EG003
rash/desquamation	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00055 affected297 at risk EG00142 affected302 at risk EG00259 affected297 at risk EG003
platelets	Blood and lymphatic system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0009 affected297 at risk EG0017 affected302 at risk EG00215 affected297 at risk EG003
constitutional symptoms - other	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0007 affected297 at risk EG00110 affected302 at risk EG00212 affected297 at risk EG003
dry mouth	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00012 affected297 at risk EG0019 affected302 at risk EG00214 affected297 at risk EG003
hemorrhoids	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0007 affected297 at risk EG0012 affected302 at risk EG0028 affected297 at risk EG003
hepatobiliary - other	Gastrointestinal disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00012 affected297 at risk EG00114 affected302 at risk EG00217 affected297 at risk EG003
infection - other	Infections and infestations	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0006 affected297 at risk EG0013 affected302 at risk EG00216 affected297 at risk EG003
mood alteration, depression	Nervous system disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00010 affected297 at risk EG0017 affected302 at risk EG00214 affected297 at risk EG003
pain, bone	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00012 affected297 at risk EG00113 affected302 at risk EG00216 affected297 at risk EG003
pain, liver	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG00012 affected297 at risk EG00113 affected302 at risk EG00213 affected297 at risk EG003
erythema multiforme	Skin and subcutaneous tissue disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0001 affected297 at risk EG0013 affected302 at risk EG0021 affected297 at risk EG003
flu-like syndrome	General disorders	NCI-CTCAE v. 3.0	Non-systematic Assessment	EG0008 affected297 at risk EG0017 affected302 at risk EG0029 affected297 at risk EG003

ID	Term
D006528	Carcinoma, Hepatocellular
D008113	Liver Neoplasms
D009369	Neoplasms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009536	Niacinamide
D009539	Nicotinic Acids
D000147	Acids, Heterocyclic
D006571	Heterocyclic Compounds
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring