Randomized Study Evaluating Ixabepilone Plus Capecitabine... | NCT00546364

NCT00546364

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Experimental	Drug: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Experimental	Drug: Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2	Active Comparator	Drug: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Drug	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)	RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.	Baseline to 6 weeks (end of Cycle 2)
Percentage of Participants With Best Response to Treatment of Complete or Partial	The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.	Baseline to 6 weeks (end of Cycle 2)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial	The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with metastatic breast cancer
Measurable disease
Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting.
Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib
Eastern Cooperative Oncology Group Performance status of 0-1
Age younger than 18 years
Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products

Exclusion Criteria:

More than 1 chemotherapy regimen for the treatment of metastatic breast cancer
Prior treatment with any epothilone, capecitabine, or docetaxel
Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication.
Any current or previous history of brain and/or leptomeningeal metastases
Neuropathy greater than Grade 2
Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
Uncontrolled diabetes mellitus
Chronic hepatitis
HIV-positive status
Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. Hormonal anticancer agents must be discontinued at least 14 days prior to study medication. Hormonal replacement therapy is acceptable
Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Dch Cancer Treatment Center		Tuscaloosa	Alabama	35401	United States
Scripps Cancer Center

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
BG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
BG002	Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2	Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
BG003	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

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00055.5(32 to 68) BG00159(39 to 79) BG00255.5(33 to 65) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00020 BG00122 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)

RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.

All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.

Posted

Number

Participants

Baseline to 6 weeks (end of Cycle 2)

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG002	Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2	Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.

Units	Counts
Participants	OG00020 OG00122 OG00220

Title

Denominators

Categories

Complete response (CR)

Title	Measurements
	OG0001 OG0011 OG0020

Partial response (PR)

Secondary

Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial

The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).

All TN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.

Posted

Number

Percentage of TN Participants

Baseline to 6 weeks (end of Cycle 2)

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG002

Secondary

Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort

The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.

All NTN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.

Posted

Number

Percentage of NTN Participants

Baseline to 6 weeks (end of Cycle 2)

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.

Secondary

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

An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward 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=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.

All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.

Posted

Number

Participants

Baseline to end of Cycle 1 (21 days), continuously

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.

Secondary

Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade

CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.

All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.

Posted

Number

Participants

Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.

Secondary

Number of Participants With Abnormalities in Serum Chemistry Laboratory Results

ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.

All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.

Posted

Number

Participants

Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.

Secondary

Time to Progression

Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.

This study was terminated due to inadequate enrollment. Consequently, time to progression was not analyzed.

Posted

Baseline to date progressive disease reported

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG002	Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2

Secondary

Duration of Response

Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.

This study was terminated due to inadequate enrollment. Consequently, duration of response was not analyzed.

Posted

Baseline (date of randomization) to date CR or PR criteria first met

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG002	Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2

Primary

Percentage of Participants With Best Response to Treatment of Complete or Partial

The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.

All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.

Posted

Number

Percentage of patients

Baseline to 6 weeks (end of Cycle 2)

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG002	Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2

Secondary

Median Number of Treatment Cycles

The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.

All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.

Posted

Median

Full Range

Treatment cycles

Day 1 to end of Cycle 18, maximum (54 weeks)

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG001	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
OG002	Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2

Arm/Groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Docetaxel	5	20	20	20
EG001	Ixabepilone 32	5	22	22	22
EG002	Ixabepilone 40	7	20	20	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
BLOOD CREATININE INCREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
EMBOLISM	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
HYPOTENSION	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
HEADACHE	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
DIZZINESS	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
SOMNOLENCE	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
DEPRESSED LEVEL OF CONSCIOUSNESS	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0021 affected20 at risk
COLONIC OBSTRUCTION	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0022 affected20 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
INCISION SITE PAIN	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
ASTHENIA	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
CATHETER THROMBOSIS	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DRY EYE	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
PHOTOPHOBIA	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
VISION BLURRED	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0020 affected20 at risk
VISUAL IMPAIRMENT	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
LACRIMATION INCREASED	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
OCULAR SURFACE DISEASE	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
WEIGHT DECREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0012 affected22 at risk EG0025 affected20 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG00110 affected22 at risk EG0025 affected20 at risk
BLOOD GLUCOSE INCREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0020 affected20 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0013 affected22 at risk EG0021 affected20 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
EOSINOPHIL COUNT DECREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0012 affected22 at risk EG0025 affected20 at risk
EJECTION FRACTION DECREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
GRANULOCYTE COUNT DECREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0015 affected22 at risk EG0024 affected20 at risk
WHITE BLOOD CELL COUNT INCREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0022 affected20 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0023 affected20 at risk
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0013 affected22 at risk EG0020 affected20 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
PALPITATIONS	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
SINUS TACHYCARDIA	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0022 affected20 at risk
FLUSHING	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
HOT FLUSH	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0013 affected22 at risk EG0020 affected20 at risk
HYPOTENSION	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
LYMPHOEDEMA	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
HYPERTENSION	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
VENOUS THROMBOSIS	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
ANXIETY	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0013 affected22 at risk EG0021 affected20 at risk
INSOMNIA	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0014 affected22 at risk EG0020 affected20 at risk
DEPRESSION	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0013 affected22 at risk EG0022 affected20 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
HEADACHE	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected20 at risk EG0013 affected22 at risk EG0023 affected20 at risk
MIGRAINE	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
DIZZINESS	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0023 affected20 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0013 affected22 at risk EG0023 affected20 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0021 affected20 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0020 affected20 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0017 affected22 at risk EG0022 affected20 at risk
EXTRAPYRAMIDAL DISORDER	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0018 affected22 at risk EG0027 affected20 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00010 affected20 at risk EG00117 affected22 at risk EG0028 affected20 at risk
VOMITING	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected20 at risk EG0018 affected22 at risk EG0026 affected20 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0008 affected20 at risk EG00112 affected22 at risk EG0029 affected20 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0015 affected22 at risk EG0021 affected20 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0012 affected22 at risk EG0020 affected20 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected20 at risk EG0014 affected22 at risk EG0025 affected20 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected20 at risk EG0017 affected22 at risk EG00212 affected20 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
LIP SWELLING	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0013 affected22 at risk EG0021 affected20 at risk
FAECAL INCONTINENCE	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
NEUTROPENIC COLITIS	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0020 affected20 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
EAR PAIN	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
INFECTION	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
PNEUMONIA	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
SINUSITIS	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0022 affected20 at risk
BRONCHITIS	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
CANDIDIASIS	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
NAIL INFECTION	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
FUNGAL SKIN INFECTION	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
NAIL BED INFECTION FUNGAL	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0022 affected20 at risk
POLLAKIURIA	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
BLADDER SPASM	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
STRESS URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0014 affected22 at risk EG0022 affected20 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0016 affected22 at risk EG0024 affected20 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0022 affected20 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0023 affected20 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0021 affected20 at risk
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected20 at risk EG0017 affected22 at risk EG0026 affected20 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected20 at risk EG0016 affected22 at risk EG0022 affected20 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected20 at risk EG0012 affected22 at risk EG0023 affected20 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG00011 affected20 at risk EG0015 affected22 at risk EG0025 affected20 at risk
MONOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0014 affected22 at risk EG0022 affected20 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected20 at risk EG00110 affected22 at risk EG0026 affected20 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0022 affected20 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0022 affected20 at risk
KOILONYCHIA	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
ONYCHOLYSIS	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
ONYCHOCLASIS	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
NAIL DISORDER	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected20 at risk EG0012 affected22 at risk EG0023 affected20 at risk
ONYCHOMADESIS	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
PALMAR ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
EXFOLIATIVE RASH	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
SKIN EXFOLIATION	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
SKIN DISCOLOURATION	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
SKIN HYPERPIGMENTATION	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0008 affected20 at risk EG00112 affected22 at risk EG0028 affected20 at risk
BREAST DISCHARGE	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
PELVIC HAEMATOMA	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
MENSTRUATION IRREGULAR	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
WOUND SECRETION	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
WOUND COMPLICATION	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0013 affected22 at risk EG0021 affected20 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0013 affected22 at risk EG0021 affected20 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0022 affected20 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0013 affected22 at risk EG0021 affected20 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
JOINT STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0011 affected22 at risk EG0025 affected20 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0013 affected22 at risk EG0023 affected20 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0013 affected22 at risk EG0022 affected20 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0014 affected22 at risk EG0024 affected20 at risk
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk
SINUS CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0013 affected22 at risk EG0021 affected20 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0022 affected20 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
PAIN	General disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected20 at risk EG0012 affected22 at risk EG0021 affected20 at risk
CHILLS	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0020 affected20 at risk
OEDEMA	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
FATIGUE	General disorders	MedDRA 12.1	Systematic Assessment	EG00012 affected20 at risk EG00117 affected22 at risk EG00215 affected20 at risk
PYREXIA	General disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected20 at risk EG0011 affected22 at risk EG0023 affected20 at risk
XEROSIS	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
ASTHENIA	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
FIBROSIS	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
CHEST PAIN	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0021 affected20 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected20 at risk EG0015 affected22 at risk EG0024 affected20 at risk
CATHETER SITE PAIN	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
CATHETER THROMBOSIS	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected20 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected20 at risk EG0013 affected22 at risk EG0023 affected20 at risk
CATHETER SITE ERYTHEMA	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected20 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected20 at risk

ID	Term
D001943	Breast Neoplasms

ID	Term
C430592	ixabepilone
D000069287	Capecitabine
D000077143	Docetaxel

Ancestor Terms

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases