A Randomized Controlled Trial Comparing Safety and Effica... | NCT00300885

ID	Type	Description	Link
2005-005245-19	EudraCT Number

Label	Type	Description	Intervention Names
Sorafenib + C/P	Experimental	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.	Drug: Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel
Placebo + C/P	Active Comparator	Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.	Drug: Carboplatin plus Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel	Drug	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.

Measure	Description	Time Frame
Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo	Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks during study treatment and every 3 months during post-treatment.	Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS determined as time (days) from the date of randomization at start of study to disease progression (radiological or clinical) or death due to any cause, if death occurs before progression.	Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35211	United States

PubMed Identifier	Type	Citation	Retractions
20212250	Result	Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrao Miziara JE, Balint B, De Marinis F, Keller A, Aren O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S, Hanna N. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol. 2010 Apr 10;28(11):1835-42. doi: 10.1200/JCO.2009.26.1321. Epub 2010 Mar 8.

Label	URL
Click here and search for information of Bayer products for Europe	View source

ID	Title	Description
FG000	Sorafenib + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.

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) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo

Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks during study treatment and every 3 months during post-treatment.

Evaluations of OS based on the ITT population. Subjects alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, if the day is missing, day 15 (the middle of the month) will be used.

Posted

Median

95% Confidence Interval

days

Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis

ID	Title	Description
OG000	Sorafenib + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
OG001	Placebo + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.

Units	Counts
Participants	OG000464 OG001462

Title

Denominators

Categories

Title	Measurements
	OG000324(277 to 423) OG001322(293 to 366)

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. Clinically meaningful improvement defined as 30% improvement in median OS (i.e. HR of 0.76923, Sorafenib+C/P over Placebo+C/P -Null: theta>=1, Alternative: theta<=0.76923). With overall one-sided alpha of 0.025, 90% power and randomization of 1:1, one formal interim analysis and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of 614 events (deaths) were required.	Log Rank		0.915	According to protocol specified O'Brien-Fleming type alpha spending function and 384 deaths at interim analysis (IA), one-sided alpha value for IA was 0.0046.	Hazard Ratio (HR)	1.15				95	0.94	1.41			Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with overall alpha of 0.025 stratified by same stratification factors as randomization

Secondary

Progression Free Survival (PFS)

PFS determined as time (days) from the date of randomization at start of study to disease progression (radiological or clinical) or death due to any cause, if death occurs before progression.

PFS (based on the ITT population) for subjects without disease progression/death at the time of analysis were censored at the last evaluation date. PFS for surviving subjects without post-baseline tumor assessments were censored at one day. In the case of an incomplete date (missing day), day 15 (the middle of the month) will be used.

Posted

Median

95% Confidence Interval

days

Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis

ID	Title	Description
OG000	Sorafenib + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
OG001	Placebo + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.

Secondary

Overall Best Response

Best overall tumor response for the ITT population was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased).

Evaluations of overall best response rate based on the ITT population.

Posted

Number

percentage of participants

ID	Title	Description
OG000	Sorafenib + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
OG001	Placebo + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.

Secondary

Duration of Response

Duration of response (PR or better) is defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented).

Evaluations of duration of response based on the ITT population.

Posted

Median

95% Confidence Interval

days

ID	Title	Description
OG000	Sorafenib + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
OG001	Placebo + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.

Secondary

Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)

Functional Assessment of Cancer Therapy - Lung cancer subscore (FACT-L). Patient reported outcome as assessed by FACT-L score. FACT-L questionnaire comprises statements about physical, social / family, emotional and functional well-being as well as additional concerns which have to be rated by the patients (0="not at all" to 4="very much"). Cycle duration defined as 21 days. Change from baseline in Total FACT-L on day 1 of cycles 3,5,7,9 (weeks 7,13,19 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation.

Evaluations of Total FACT-L based on the ITT population.

Posted

Mean

Standard Deviation

Scores on a scale

Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis

ID	Title	Description
OG000	Sorafenib + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
OG001	Placebo + C/P

Secondary

Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)

Lung Cancer Symptoms (LCS) subscale ranges from 0 (severe debilitation) to 28 (asymptomatic). Cycle duration defined as 21 days. Change from baseline in LCS Subscale on day 1 of cycles 2 through 9 (weeks 4,7,10,13,16,19,22 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation.

Evaluations of LCS Subscale based on the ITT population.

Posted

Mean

Standard Deviation

Scores on a scale

Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis

ID	Title	Description
OG000	Sorafenib + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
OG001	Placebo + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Allergic reaction	Immune system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00011 affected463 at risk EG0014 affected459 at risk
Neutrophils	Blood and lymphatic system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00015 affected463 at risk EG0017 affected459 at risk
Hemoglobin	Blood and lymphatic system disorders	NCI CTC v3.0	Non-systematic Assessment	EG00011 affected463 at risk EG0018 affected459 at risk
Hemolysis	Blood and lymphatic system disorders	NCI CTC v3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Platelets	Blood and lymphatic system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0008 affected463 at risk EG0012 affected459 at risk
Leukocytes	Blood and lymphatic system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0011 affected459 at risk
Supraventricular arrhythmia, atrial fibrillation	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0011 affected459 at risk
Conduction abnormality, asystole	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Supraventricular arrhythmia, sinus bradycardia	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Supraventricular arrhythmia, supravent extrasystoles (pac;premnodal/junct contr)	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Supraventricular arrhythmia, supraventricular tachycardia	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0010 affected459 at risk
Supraventricular arrhythmia, sinus tachycardia	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
vasovagal episode	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Ventricular arrhythmia, ventricular fibrillation	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Ventricular arrhythmia, ventricular arrhythmia NOS	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Ventricular arrhythmia, ventricular tachycardia	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Cardiopulmonary arrest	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0012 affected459 at risk
Pericardial effusion	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0013 affected459 at risk
Hypertension	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0012 affected459 at risk
Cardiac ischemia/infarction	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0014 affected459 at risk
Hypotension	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
Left ventricular systolic dysfunction	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Death not associated with CTCAE term, death NOS	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0004 affected463 at risk EG0012 affected459 at risk
Death not associated with CTCAE term, disease progression NOS	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00023 affected463 at risk EG00124 affected459 at risk
Death not associated with CTCAE term, multi-organ failure	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Death not associated with CTCAE term, sudden death	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0011 affected459 at risk
Diabetes	Endocrine disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Fever	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00017 affected463 at risk EG00110 affected459 at risk
Fatigue	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0005 affected463 at risk EG0014 affected459 at risk
Weight loss	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Constitutional symptoms - other	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00019 affected463 at risk EG00113 affected459 at risk
Rigors/chills	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Anorexia	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0012 affected459 at risk
Colitis	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
Constipation	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0011 affected459 at risk
Dehydration	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0009 affected463 at risk EG0014 affected459 at risk
Diarrhea	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0005 affected463 at risk EG0016 affected459 at risk
Dysphagia	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0012 affected459 at risk
Enteritis	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Gastritis	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
Mucositis (clinical exam), oral cavity	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Necrosis, GI, anus	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Nausea	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0005 affected463 at risk EG0015 affected459 at risk
Ileus	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0012 affected459 at risk
Perforation, GI, colon	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Ulcer, GI, stomach	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Vomiting	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0012 affected459 at risk
Hemorrhage, GI, abdomen NOS	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
Hemorrhage, GI, colon	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0012 affected459 at risk
Hemorrhage, GI, duodenum	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Hemorrhage, GI, stomach	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Hemorrhage, GI, lower GI NOS	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Hemorrhage, GI, upper GI, NOS	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Hemorrhage pulmonary, bronchopulmonary NOS	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0012 affected459 at risk
Hemorrhage pulmonary, bronchus	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Hemorrhage pulmonary, lung	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00011 affected463 at risk EG0018 affected459 at risk
Hemorrhage pulmonary, nose	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Hemorrhage pulmonary, respiratory tract NOS	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0005 affected463 at risk EG0011 affected459 at risk
Cholecystitis	Hepatobiliary disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
Hepatobilary - other	Hepatobiliary disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Pancreatitis	Hepatobiliary disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Infection (documented clinically), abdomen NOS	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Infection (documented clinically), blood	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0009 affected463 at risk EG0010 affected459 at risk
Infection (documented clinically), bladder (urinary)	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Infection (documented clinically), bronchus	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0013 affected459 at risk
Infection (documented clinically), lung (pneumonia)	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG00025 affected463 at risk EG00110 affected459 at risk
Infection (documented clinically), pleura (empyema)	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Infection (documented clinically), skin (cellulitis)	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
Infection (documented clinically), upper airway NOS	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0011 affected459 at risk
Infection (documented clinically), urinary tract NOS	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Infection (documented clinically), vein	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Infection with normal ANC, blood	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0012 affected459 at risk
Infection with normal ANC, bronchus	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0013 affected459 at risk
Infection with normal ANC, catheter-related	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Infection with normal ANC, colon	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Febrile neutropenia	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG00016 affected463 at risk EG0018 affected459 at risk
Infection with normal ANC, lung (pneumonia)	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0006 affected463 at risk EG0013 affected459 at risk
Infection with normal ANC, upper airway NOS	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Infection - other	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0011 affected459 at risk
Infection with unknown ANC, anal/perianal	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Infection with unknown ANC, lung (pneumonia)	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0005 affected463 at risk EG0012 affected459 at risk
Infection with unknown ANC, pleura (empyema)	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Edema: limb	Blood and lymphatic system disorders	NCI CTC v3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Fracture	Musculoskeletal and connective tissue disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0016 affected459 at risk
Muscuskeletal - other	Musculoskeletal and connective tissue disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0011 affected459 at risk
Muscle weakness, extremity-lower	Musculoskeletal and connective tissue disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0012 affected459 at risk
Muscle weakness, whole body/generalized	Musculoskeletal and connective tissue disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
Alkaline phosphatase	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
ALT	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
AST	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Creatinine	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
GGT	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Bilirubin (hyperbilirubinemia)	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Hypercalcemia	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Hyperglycemia	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Hyperkalemia	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Hypoglycemia	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
Hypokalemia	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
Hyponatremia	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
Hypophosphatemia	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Mood alteration, agitation	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
CNS ischemia	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0017 affected459 at risk
Confusion	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0006 affected463 at risk EG0013 affected459 at risk
Dizziness	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0012 affected459 at risk
Mood alteration, euphoria	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Speech impairment	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Mood alteration, depression	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0010 affected459 at risk
Neuropathy: motor	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
Neurology - other	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0015 affected459 at risk
Neuropathy: sensory	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0016 affected459 at risk
Seizure	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0011 affected459 at risk
Somnolence	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
Syncope (fainting)	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
Pain, back	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0004 affected463 at risk EG0012 affected459 at risk
Pain, chest/thorax NOS	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0015 affected459 at risk
Pain, chest wall	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
Pain, tumor pain	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0014 affected459 at risk
Pain, abdomen NOS	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0012 affected459 at risk
Pain, joint	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
Pain, muscle	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Pain, bone	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0003 affected463 at risk EG0011 affected459 at risk
Pain, liver	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Pain, pain NOS	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Pain, stomach	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
ARDS	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0004 affected463 at risk EG0017 affected459 at risk
Fistula, pulmonary, bronchus	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Fistula, pulmonary, lung	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
Airway obstruction, bronchus	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0012 affected459 at risk
Pulmonary - other	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00017 affected463 at risk EG0014 affected459 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0007 affected463 at risk EG0011 affected459 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0007 affected463 at risk EG0010 affected459 at risk
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00024 affected463 at risk EG00123 affected459 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Cystitis	Renal and urinary disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
Renal failure	Renal and urinary disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0004 affected463 at risk EG0010 affected459 at risk
Urinary retention	Renal and urinary disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0012 affected459 at risk
Hand-foot skin reaction	Skin and subcutaneous tissue disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
Rash/desquamation	Skin and subcutaneous tissue disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0004 affected463 at risk EG0010 affected459 at risk
Intraop injury, bone	Injury, poisoning and procedural complications	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Syndromes - other	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Thrombosis/embolism (vascular access)	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0013 affected459 at risk
Vascular - other	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Thrombosis/thrombus/embolism	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00016 affected463 at risk EG00117 affected459 at risk
Bone marrow cellularity	Blood and lymphatic system disorders	NCI CTC v3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0012 affected459 at risk
Supraventricular arrhythmia, atrial	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
cardiac general - other	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0011 affected459 at risk
ascites	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Fistula, GI, abdomen NOS	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
perforation, GI, stomach	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Hematoma	Blood and lymphatic system disorders	NCI CTC v3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Hemorrhage, GI, esophagus	Blood and lymphatic system disorders	NCI CTC v3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Hemorrhage, Gu, bladder	Blood and lymphatic system disorders	NCI CTC v3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Infection (documented clinically), anal/perianal	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Infection (documented clinically), mucosa	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Infection with normal ANC, anal/perianal	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0002 affected463 at risk EG0010 affected459 at risk
Infection with normal ANC, pleura (empyema)	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Infection with normal ANC, urethra	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Opportunistic infection	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Infection with unknown ANC, blood	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0012 affected459 at risk
Infection with unknown ANC, muscle (infection myositis)	Infections and infestations	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Cognitive disturbance	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Pain, neck	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Bruising	Skin and subcutaneous tissue disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk
Flushing	Skin and subcutaneous tissue disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Intraop injury, lung	Surgical and medical procedures	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Flu-like syndrome	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0001 affected463 at risk EG0010 affected459 at risk
Peripheral arterial ischemia	Vascular disorders	NCI CTC v.3.0	Non-systematic Assessment	EG0000 affected463 at risk EG0011 affected459 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutrophils	Blood and lymphatic system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000170 affected463 at risk EG001168 affected459 at risk
Hemoglobin	Blood and lymphatic system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000145 affected463 at risk EG001148 affected459 at risk
Platelets	Blood and lymphatic system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000140 affected463 at risk EG00167 affected459 at risk
Leukocytes	Blood and lymphatic system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00078 affected463 at risk EG00167 affected459 at risk
Hypertension	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00090 affected463 at risk EG00146 affected459 at risk
Fever	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00085 affected463 at risk EG00160 affected459 at risk
Insomnia	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00079 affected463 at risk EG00183 affected459 at risk
Fatigue	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000251 affected463 at risk EG001228 affected459 at risk
Weight loss	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00099 affected463 at risk EG00157 affected459 at risk
Anorexia	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000149 affected463 at risk EG001122 affected459 at risk
Constipation	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000126 affected463 at risk EG001107 affected459 at risk
Diarrhea	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000205 affected463 at risk EG001107 affected459 at risk
Heartburn	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00047 affected463 at risk EG00126 affected459 at risk
Mucositis (clinical exam), oral cavity	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00077 affected463 at risk EG00133 affected459 at risk
Nausea	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000201 affected463 at risk EG001204 affected459 at risk
Vomiting	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000122 affected463 at risk EG001108 affected459 at risk
Edema: limb	Blood and lymphatic system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00052 affected463 at risk EG00151 affected459 at risk
Dizziness	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00055 affected463 at risk EG00152 affected459 at risk
Neuropathy: sensory	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000236 affected463 at risk EG001250 affected459 at risk
Pain, back	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00050 affected463 at risk EG00153 affected459 at risk
Pain, chest/thorax NOS	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00070 affected463 at risk EG00170 affected459 at risk
Pain, extremity-limb	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00069 affected463 at risk EG00158 affected459 at risk
Pain, abdomen NOS	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00060 affected463 at risk EG00150 affected459 at risk
Pain, head/headache	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00052 affected463 at risk EG00150 affected459 at risk
Pain, joint	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00083 affected463 at risk EG001100 affected459 at risk
Pain, muscle	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00096 affected463 at risk EG001120 affected459 at risk
Pain, bone	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00052 affected463 at risk EG00141 affected459 at risk
Cough	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000142 affected463 at risk EG001138 affected459 at risk
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG000138 affected463 at risk EG001136 affected459 at risk
Alopecia	Skin and subcutaneous tissue disorders	NCI CTC v3.0	Non-systematic Assessment	EG000214 affected463 at risk EG001215 affected459 at risk
Hand-foot skin reaction	Skin and subcutaneous tissue disorders	NCI CTC v3.0	Non-systematic Assessment	EG000113 affected463 at risk EG00124 affected459 at risk
Pruritus	Skin and subcutaneous tissue disorders	NCI CTC v3.0	Non-systematic Assessment	EG00066 affected463 at risk EG00135 affected459 at risk
Rash/desquamation	Skin and subcutaneous tissue disorders	NCI CTC v3.0	Non-systematic Assessment	EG000239 affected463 at risk EG00180 affected459 at risk
Allergic reaction	Immune system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00029 affected463 at risk EG00130 affected459 at risk
Hypotension	Cardiac disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00036 affected463 at risk EG00128 affected459 at risk
Sweating	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00030 affected463 at risk EG00131 affected459 at risk
Dehydration	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00036 affected463 at risk EG00116 affected459 at risk
Mucositis (functional/symptomatic), oral cavity	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00025 affected463 at risk EG00112 affected459 at risk
Taste alteration	Gastrointestinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00043 affected463 at risk EG00138 affected459 at risk
Hemorrhage pulmonary, nose	Vascular disorders	NCI CTC v3.0	Non-systematic Assessment	EG00046 affected463 at risk EG00121 affected459 at risk
Pain, throat / pharynx / larynx	General disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00024 affected463 at risk EG00117 affected459 at risk
Hypokalemia	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00046 affected463 at risk EG00125 affected459 at risk
Hypomagnesemia	Metabolism and nutrition disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00040 affected463 at risk EG00126 affected459 at risk
Mood alteration, anxiety	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00042 affected463 at risk EG00135 affected459 at risk
Mood alteration, depression	Nervous system disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00028 affected463 at risk EG00120 affected459 at risk
Voice changes	Respiratory, thoracic and mediastinal disorders	NCI CTC v.3.0	Non-systematic Assessment	EG00028 affected463 at risk EG00122 affected459 at risk
Dry skin	Skin and subcutaneous tissue disorders	NCI CTC v3.0	Non-systematic Assessment	EG00041 affected463 at risk EG00124 affected459 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	NCI CTC v3.0	Non-systematic Assessment	EG00025 affected463 at risk EG0014 affected459 at risk
Pain, tumor pain	General disorders	NCI CTC v3.0	Non-systematic Assessment	EG00022 affected463 at risk EG00123 affected459 at risk
Rhinitis	Immune system disorders	NCI CTC v3.0	Non-systematic Assessment	EG00018 affected463 at risk EG00123 affected459 at risk
Muscle weakness, whole body / generalized	Musculoskeletal and connective tissue disorders	NCI CTC v3.0	Non-systematic Assessment	EG00027 affected463 at risk EG00120 affected459 at risk
Hyperglycemia	Metabolism and nutrition disorders	NCI CTC v3.0	Non-systematic Assessment	EG00019 affected463 at risk EG00123 affected459 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract 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
D056831	Coordination Complexes
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Sorafenib + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
BG001	Placebo + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sorafenib + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.			272	463	454	463
EG001	Placebo + C/P	Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.			195	459	450	459