A Study of Ixabepilone as Second-line Therapy for Locally... | NCT00883116

ID	Type	Description	Link
2008-007167-16

Label	Type	Description	Intervention Names
Ixabepilone, 40 mg/m^2, intravenously (IV)	Experimental	Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression	Drug: Ixabepilone
Control chemotherapy (Paclitaxel or Doxorubicin)	Active Comparator	Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.	Drug: Doxorubicin Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
Ixabepilone	Drug		Ixabepilone, 40 mg/m^2, intravenously (IV)	Ixempra BMS-247550

Measure	Description	Time Frame
Overall Survival (OS)	Survival was defined as the time from the date of randomization until the date of death. If the patient did not die, OS was censored on the last date he or she was known to be alive.	Date of randomization to date of death or last date censored to up to approximately 26 months

Measure	Description	Time Frame
Progression-free Survival	Progression-free survival was defined as the time from randomization to the date of documented disease progression. Patients who died without a reported prior progression were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last tumor assessment. Participants who did not have any on-study tumor assessments were censored on the date they were randomized. Measurable disease was present if the patient had 1 or more measurable lesions.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria

Women aged 18 years and older
Histologic or cytologic diagnosis of endometrial carcinoma
Evidence that the cancer is advanced, recurrent, or metastatic and not curable by local measures, such as surgery or radiation.
Karnofsky performance status >=70
Measurable or nonmeasurable disease that has progressed since last treatment.
- If only disease is confined to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology.
- Disease in a previously irradiated field is acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy.
All therapy directed at endometrial cancer must be discontinued 21 days prior to start of treatment, except for hormonal therapy which must be discontinued at least 1 week prior to start of study treatment. Concurrent administration of hormone replacement therapy is allowed.
Prior therapy: Participants must have failed 1 prior platinum-based chemotherapeutic regimen for endometrial cancer. May have received 2 prior chemotherapy regimens if 1 regimen was given for stage I or II disease. May have received any number of prior non-cytotoxic regimens such as monoclonal antibodies, cytokines, signal transduction inhibitors, or hormonal therapy. Previous radiation therapy is allowed.

Key Exclusion Criteria

Carcinosarcoma (malignant mixed mullerian tumor)
Endometrial leiomyosarcoma and endometrial stromal sarcomas
Participants who received no prior chemotherapy for endometrial cancer or ≥2 prior chemotherapy regimens (exceptions defined in protocol)
Known brain metastases
Receipt of prior ixabepilone therapy
Concurrent active infection requiring antibiotics or other therapy
Concurrent unstable disease or other debilitating illness, such as congestive heart failure, unstable angina, myocardial infarction, or other cardiac disease that could jeopardize participation, within the last 6 months
For participants whose prior therapy did not include an anthracycline and therefore may be randomized to doxorubicin, left ventricular ejection fraction <50% as measured by multigated radionuclide angiography or echocardiography
History of malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast, within the last 5 years that has not been treated with chemotherapy
Known human immunodeficiency viral infection
Psychiatric disorders or other conditions rendering the participant incapable of complying with protocol requirements
Absolute neutrophil count <1500/mm^3
Platelets <100,000/mm^3
Hemoglobin <9 g/dL
Total bilirubin >1.5*upper limit of normal (ULN), except for those with Gilbert's disease
Aspartate aminotransferase or alanine aminotransferase >2.5*ULN
Serum creatinine >1.5*ULN
Grade ≥2 neuropathy (sensory or motor)
No concurrent therapy (chemotherapy, hormonal, or investigational) directed at endometrial cancer during the study

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

Facility	Status	City	State	ZIP	Country	Contacts
University Of South Alabama		Mobile	Alabama	36604	United States
Rocky Mountain Gynecologic Oncology

PubMed Identifier	Type	Citation	Retractions
25925990	Derived	McMeekin S, Dizon D, Barter J, Scambia G, Manzyuk L, Lisyanskaya A, Oaknin A, Ringuette S, Mukhopadhyay P, Rosenberg J, Vergote I. Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. Gynecol Oncol. 2015 Jul;138(1):18-23. doi: 10.1016/j.ygyno.2015.04.026. Epub 2015 Apr 26.

ID	Title	Description
FG000	Ixabepilone, 40 mg/m^2, IV	Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
FG001	Control Chemotherapy

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)

Survival was defined as the time from the date of randomization until the date of death. If the patient did not die, OS was censored on the last date he or she was known to be alive.

All randomized participants

Posted

Median

95% Confidence Interval

Months

Date of randomization to date of death or last date censored to up to approximately 26 months

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2, Intravenously (IV)	Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
OG001	Control With Chemotherapy (Paclitaxel or Doxorubicin)	Participants received paclitaxel, 175 mg/m^2, given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2, given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.

Units	Counts
Participants	OG000248 OG001248

Title

Denominators

Categories

Title	Measurements
	OG00010.9(8.5 to 12.7) OG00112.3(10.7 to 15.4)

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		Log Rank		0.0397		Hazard Ratio (HR)	1.3			2-Sided	95	1.0	1.7					Superiority or Other

Secondary

Progression-free Survival

Progression-free survival was defined as the time from randomization to the date of documented disease progression. Patients who died without a reported prior progression were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last tumor assessment. Participants who did not have any on-study tumor assessments were censored on the date they were randomized. Measurable disease was present if the patient had 1 or more measurable lesions.

All participants with measurable disease at randomization

Posted

Median

95% Confidence Interval

Months

Date of randomization to date of disease progression or death (or date of last tumor assessment for those who did not die or progress) up to approximately 22 months

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2, Intravenously (IV)	Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
OG001	Control With Chemotherapy (Paclitaxel or Doxorubicin)	Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.

Secondary

Best Overall Response Rate

Best overall response rate was defined as the number of participants whose best response was either partial response (PR) or complete response (CR) divided by the number of participants in the treatment group. Overall tumor response was based on an integration of the evaluation of target, nontarget, and new lesions. CR=Disappearance of all clinical and radiologic evidence of target lesions. PR=At least 30% reduction in the sum of diameters of all target lesions; taking as reference the baseline study measurement. Changes in tumor measurements need not be confirmed by repeat measurements performed after the criteria for response were first met.

All randomized participants with measurable disease

Posted

Number

95% Confidence Interval

Percentage of participants

Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2, Intravenously (IV)	Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
OG001	Control With Chemotherapy (Paclitaxel or Doxorubicin)	Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.

Secondary

Number of Participants With a Serious Adverse Event (SAE), an SAE Related to Study Drug, Death as Outcome, a Peripheral Neuropathy Adverse Event (AE), a Grade 3 or Higher AE, and an AE Related to Study Drug

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related to study drug=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

All participants who received at least 1 dose of ixabepilone

Posted

Number

Participants

From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days

ID	Title	Description
OG000	Ixabepilone, 40 mg/m^2, Intravenously (IV)	Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
OG001	Control With Chemotherapy (Paclitaxel or Doxorubicin)	Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood creatinine increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Device malfunction	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Embolism	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Endocarditis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected248 at risk EG0016 affected171 at risk EG0020 affected68 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Rectal obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0012 affected171 at risk EG0021 affected68 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Hypothyroidism	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0013 affected171 at risk EG0020 affected68 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Right ventricular failure	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0016 affected171 at risk EG0020 affected68 at risk
Dyspnoea exertional	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00010 affected248 at risk EG00110 affected171 at risk EG0021 affected68 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 affected248 at risk EG0015 affected171 at risk EG0020 affected68 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0012 affected171 at risk EG0020 affected68 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0013 affected171 at risk EG0020 affected68 at risk
Sudden death	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
White blood cell count decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Performance status decreased	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Presyncope	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0012 affected171 at risk EG0020 affected68 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Cellulitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Clostridium bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Device related infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Haemoglobin decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Inflammation	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Localised infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected248 at risk EG0017 affected171 at risk EG0020 affected68 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected248 at risk EG0014 affected171 at risk EG0020 affected68 at risk
Salmonellosis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 affected248 at risk EG0012 affected171 at risk EG0021 affected68 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected248 at risk EG0016 affected171 at risk EG0022 affected68 at risk
Asthenia	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Confusional state	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Ileus	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Incorrect dose administered	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
International normalised ratio increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0012 affected171 at risk EG0020 affected68 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected248 at risk EG0014 affected171 at risk EG0020 affected68 at risk
Pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Respiratory moniliasis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Syncope	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0011 affected171 at risk EG0021 affected68 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected248 at risk EG0017 affected171 at risk EG0021 affected68 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Chromaturia	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected248 at risk EG0014 affected171 at risk EG0020 affected68 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0014 affected171 at risk EG0020 affected68 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected248 at risk EG0015 affected171 at risk EG0020 affected68 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected248 at risk EG0012 affected171 at risk EG0021 affected68 at risk
General physical health deterioration	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Infectious peritonitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Neutrophil count decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected248 at risk EG0011 affected171 at risk EG0021 affected68 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0012 affected171 at risk EG0021 affected68 at risk
Septic shock	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected248 at risk EG0014 affected171 at risk EG0020 affected68 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Alanine aminotransferase increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Anuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Candidiasis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Death	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Fatigue	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0010 affected171 at risk EG0021 affected68 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0011 affected171 at risk EG0021 affected68 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0012 affected171 at risk EG0020 affected68 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected248 at risk EG0010 affected171 at risk EG0020 affected68 at risk
Platelet count decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected248 at risk EG0011 affected171 at risk EG0020 affected68 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected248 at risk EG0012 affected171 at risk EG0020 affected68 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 affected248 at risk EG0013 affected171 at risk EG0020 affected68 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dizziness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00024 affected248 at risk EG00110 affected171 at risk EG0021 affected68 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00017 affected248 at risk EG00114 affected171 at risk EG0020 affected68 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00082 affected248 at risk EG00145 affected171 at risk EG00212 affected68 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected248 at risk EG0011 affected171 at risk EG0026 affected68 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00017 affected248 at risk EG0013 affected171 at risk EG0025 affected68 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00021 affected248 at risk EG00112 affected171 at risk EG0028 affected68 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00011 affected248 at risk EG00113 affected171 at risk EG0021 affected68 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00023 affected248 at risk EG00118 affected171 at risk EG0021 affected68 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00037 affected248 at risk EG00133 affected171 at risk EG0028 affected68 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00013 affected248 at risk EG0017 affected171 at risk EG0020 affected68 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00035 affected248 at risk EG00125 affected171 at risk EG0026 affected68 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00023 affected248 at risk EG00116 affected171 at risk EG0025 affected68 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00012 affected248 at risk EG0012 affected171 at risk EG0025 affected68 at risk
Haemoglobin decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG00013 affected248 at risk EG00111 affected171 at risk EG0023 affected68 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG000118 affected248 at risk EG001101 affected171 at risk EG00217 affected68 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00079 affected248 at risk EG00110 affected171 at risk EG00229 affected68 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG00017 affected248 at risk EG00122 affected171 at risk EG0024 affected68 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG00013 affected248 at risk EG0012 affected171 at risk EG0024 affected68 at risk
Weight increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 affected248 at risk EG0012 affected171 at risk EG0024 affected68 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00045 affected248 at risk EG00124 affected171 at risk EG0025 affected68 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG000102 affected248 at risk EG00163 affected171 at risk EG00236 affected68 at risk
Asthenia	General disorders	MedDRA 14.1	Systematic Assessment	EG00039 affected248 at risk EG00124 affected171 at risk EG00211 affected68 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Systematic Assessment	EG00021 affected248 at risk EG00128 affected171 at risk EG0020 affected68 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00058 affected248 at risk EG00168 affected171 at risk EG00211 affected68 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00016 affected248 at risk EG00112 affected171 at risk EG0022 affected68 at risk
Weight decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG00048 affected248 at risk EG00128 affected171 at risk EG0023 affected68 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected248 at risk EG00114 affected171 at risk EG0021 affected68 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00062 affected248 at risk EG00146 affected171 at risk EG00216 affected68 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00046 affected248 at risk EG0019 affected171 at risk EG00222 affected68 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00077 affected248 at risk EG00149 affected171 at risk EG0027 affected68 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00014 affected248 at risk EG0018 affected171 at risk EG0020 affected68 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00076 affected248 at risk EG00147 affected171 at risk EG0028 affected68 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected248 at risk EG00111 affected171 at risk EG0020 affected68 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00032 affected248 at risk EG0014 affected171 at risk EG00217 affected68 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00016 affected248 at risk EG00118 affected171 at risk EG0021 affected68 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00073 affected248 at risk EG00148 affected171 at risk EG0028 affected68 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00021 affected248 at risk EG00115 affected171 at risk EG0023 affected68 at risk
Fatigue	General disorders	MedDRA 14.1	Systematic Assessment	EG000125 affected248 at risk EG00188 affected171 at risk EG00221 affected68 at risk
Headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00019 affected248 at risk EG00116 affected171 at risk EG0020 affected68 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00015 affected248 at risk EG00114 affected171 at risk EG0022 affected68 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00028 affected248 at risk EG00113 affected171 at risk EG0022 affected68 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected248 at risk EG0013 affected171 at risk EG0024 affected68 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Systematic Assessment	EG00027 affected248 at risk EG00120 affected171 at risk EG0026 affected68 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00010 affected248 at risk EG0013 affected171 at risk EG0025 affected68 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00021 affected248 at risk EG0017 affected171 at risk EG0023 affected68 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00022 affected248 at risk EG0019 affected171 at risk EG0023 affected68 at risk

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D004224	Diterpenes
D013729	Terpenes
D004467	Economics
D004472	Health Care Economics and Organizations

ID	Title	Description
BG000	Ixabepilone, 40 mg/m^2, IV	Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
BG001	Control Chemotherapy	Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ixabepilone, 40 mg/m^2, Intravenously (IV)	Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression	89	248	233	248
EG001	Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)	Participants received doxorubicin, 60 mg/m^2 given intravenously (IV) per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.	59	171	160	171
EG002	Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)	Participants received paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity.	11	68	63	68

ID	Term
C430592	ixabepilone
D004317	Doxorubicin
D017239	Paclitaxel
D013660	Taxes