A Randomized Phase 2 Study of Ixabepilone Plus Carboplati... | NCT00723957

Label	Type	Description	Intervention Names
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Experimental		Drug: Ixabepilone, 32 mg/m^2 Drug: Carboplatin (area under the concentration curve [AUC] 6)
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Active Comparator		Drug: Paclitaxel, 200 mg/m^2 Drug: Carboplatin (area under the concentration curve [AUC] 6)

Name	Type	Description	Arm Group Labels	Other Names
Ixabepilone, 32 mg/m^2	Drug	Intravenous (IV) solutions, ixabepilone, 32 mg/m^2	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)

Measure	Description	Time Frame
Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors	Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.	Randomization to disease progression or death (maximum reached: 14.39 months )

Measure	Description	Time Frame
Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors	Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Cancer Center		La Jolla	California	90237	United States
Uof Md,Greenebaum Cancer Ctr.

PubMed Identifier	Type	Citation	Retractions
23589560	Derived	Edelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15.

ID	Title	Description
FG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles

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

Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors

Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.

All randomized participants with βIII-tubulin positive tumors and who received study drug

Posted

Median

95% Confidence Interval

Months

Randomization to disease progression or death (maximum reached: 14.39 months )

ID	Title	Description
OG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
OG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles

Units	Counts
Participants	OG00053 OG00151

Title

Denominators

Categories

Title	Measurements
	OG0004.27± NA(2.89 to 5.65) OG0014.27± NA(3.61 to 6.05)

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		Regression, Cox				Hazard Ratio (HR)	1.04			1-Sided	90		1.41					Superiority or Other (legacy)
OG000 OG001	P-value is 1-sided	Log Rank

Secondary

Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors

All randomized participants who had βIII-tubulin positive tumors and who received study drug

Posted

Median

95% Confidence Interval

Months

Randomization to disease progression or death (maximum reached: 12.29 months)

ID	Title	Description
OG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
OG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles

Secondary

Progression-free Survival in the Overall Population

All randomized participants who received study drug

Posted

Median

95% Confidence Interval

Months

Randomization to disease progression or death, assessed to 12.29 months

ID	Title	Description
OG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
OG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles

Secondary

Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)

Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Posted

Mean

95% Confidence Interval

Percentage of participants

At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles

ID	Title	Description
OG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
OG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles

Secondary

Time to Response

Time to Response is defined as the time from randomization date until the date of first response (Partial Response [PR] or Complete Response [CR])

All randomized participants

Posted

Median

Full Range

Weeks

Randomization to date of first response (PR or CR)

ID	Title	Description
OG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
OG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles

Units	Counts
Participants

Secondary

Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy

An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment.

All participants who received any investigational product.

Posted

Number

Participants

Days 1 through 21, continuously

ID	Title	Description
OG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
OG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles

Secondary

Number of Participants With Hematology Laboratory Results of Grade 3 or 4

LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: \

All participants who received any investigational product.

Posted

Number

Participants

At screening and weekly during 21-day cycle

ID	Title	Description
OG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
OG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles

Secondary

Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results

ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Aspartate aminotransferase (AST) Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN

All participants who received any investigational product.

Posted

Number

Participants

At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)

ID	Title	Description
OG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
OG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles

Secondary

Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors

Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date.

All participants randomized to receive treatment

Posted

Median

95% Confidence Interval

Months

Randomization to death or last known alive date, up to 31.34 months

ID	Title	Description
OG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
OG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
BLOOD CREATININE INCREASED	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected95 at risk EG0010 affected96 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
SINUS TACHYCARDIA	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
PERICARDITIS CONSTRICTIVE	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
PHLEBITIS	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
HYPOTENSION	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
SYNCOPE	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected95 at risk EG0011 affected96 at risk
HEADACHE	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
MYELITIS	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
DIZZINESS	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected95 at risk EG0010 affected96 at risk
CONVULSION	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0011 affected96 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0012 affected96 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0011 affected96 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
PEPTIC ULCER	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
PNEUMONIA	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0003 affected95 at risk EG0013 affected96 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0011 affected96 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0004 affected95 at risk EG0010 affected96 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0011 affected96 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected95 at risk EG0010 affected96 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected95 at risk EG0013 affected96 at risk
FRACTURE	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0010 affected96 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0012 affected96 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected95 at risk EG0010 affected96 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
BRONCHIAL HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
OESOPHAGOBRONCHIAL FISTULA	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
PAIN	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
FATIGUE	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0011 affected96 at risk
PYREXIA	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0012 affected96 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0012 affected96 at risk
SARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected95 at risk EG0011 affected96 at risk
NON-SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0012 affected96 at risk
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected95 at risk EG0011 affected96 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
INSOMNIA	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0007 affected95 at risk EG0017 affected96 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected95 at risk EG0016 affected96 at risk
HEADACHE	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0005 affected95 at risk EG0017 affected96 at risk
DIZZINESS	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0008 affected95 at risk EG0017 affected96 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0004 affected95 at risk EG0016 affected96 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0009 affected95 at risk EG0019 affected96 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00017 affected95 at risk EG00122 affected96 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0008 affected95 at risk EG00121 affected96 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00041 affected95 at risk EG00131 affected96 at risk
VOMITING	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00017 affected95 at risk EG00110 affected96 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00015 affected95 at risk EG00116 affected96 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00012 affected95 at risk EG00113 affected96 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected95 at risk EG0016 affected96 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0005 affected95 at risk EG0012 affected96 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG00030 affected95 at risk EG00127 affected96 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG00025 affected95 at risk EG00113 affected96 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG00012 affected95 at risk EG00110 affected96 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG00032 affected95 at risk EG00122 affected96 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG00017 affected95 at risk EG0011 affected96 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0005 affected95 at risk EG0015 affected96 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG00045 affected95 at risk EG00155 affected96 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0004 affected95 at risk EG0019 affected96 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00015 affected95 at risk EG00129 affected96 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0006 affected95 at risk EG0014 affected96 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00015 affected95 at risk EG00125 affected96 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0004 affected95 at risk EG0017 affected96 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0009 affected95 at risk EG00115 affected96 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0008 affected95 at risk EG0019 affected96 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0005 affected95 at risk EG0014 affected96 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG00011 affected95 at risk EG0015 affected96 at risk
PAIN	General disorders	MedDRA 13.0	Systematic Assessment	EG0006 affected95 at risk EG0014 affected96 at risk
FATIGUE	General disorders	MedDRA 13.0	Systematic Assessment	EG00032 affected95 at risk EG00130 affected96 at risk
PYREXIA	General disorders	MedDRA 13.0	Systematic Assessment	EG00010 affected95 at risk EG0016 affected96 at risk
ASTHENIA	General disorders	MedDRA 13.0	Systematic Assessment	EG00012 affected95 at risk EG00117 affected96 at risk
CHEST PAIN	General disorders	MedDRA 13.0	Systematic Assessment	EG00010 affected95 at risk EG00114 affected96 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 13.0	Systematic Assessment	EG0005 affected95 at risk EG0015 affected96 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
C430592	ixabepilone
D017239	Paclitaxel
C089957	BMS 181339
D016190	Carboplatin
D019540	Area Under Curve

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes
D013223	Statistics as Topic
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D010599	Pharmacokinetics
D008660	Metabolism
D002620	Pharmacological and Toxicological Phenomena
D010829	Physiological Phenomena
D011634	Public Health
D004778	Environment and Public Health

ID	Title	Description
BG000	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
BG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
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	Ixabepilone, 32 mg/m^2 + Carboplatin (AUC)	Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles			27	95	88	95
EG001	Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)	Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles			28	96	91	96