Trial Outcomes & Findings for Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (NCT NCT00058019)

Last Updated: 2014-05-23

Results Overview

The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

up to 3 years

Results posted on

2014-05-23

Participant Flow

One patient never received treatment and was excluded from analysis.

Participant milestones

Participant milestones
Measure	Cohort 1 (Chemosensitive) Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.	Cohort 2 (Chmoresistant) Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
Overall Study STARTED	39	12
Overall Study COMPLETED	39	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (Chemosensitive) n=39 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.	Cohort 2 (Chmoresistant) n=12 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.	Total n=51 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	73 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	7 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	34 Participants n=5 Participants	12 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
LDH elevation Yes	16 Participants n=5 Participants	6 Participants n=7 Participants	22 Participants n=5 Participants
LDH elevation No	23 Participants n=5 Participants	6 Participants n=7 Participants	29 Participants n=5 Participants
Prior therapies 1	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Prior therapies 2-3	17 Participants n=5 Participants	5 Participants n=7 Participants	22 Participants n=5 Participants
Prior therapies 4 or more	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Prior rituximab Yes	34 Participants n=5 Participants	11 Participants n=7 Participants	45 Participants n=5 Participants
Prior rituximab No	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 years

Outcome measures

Outcome measures
Measure	Cohort 1 (Chemosensitive) n=39 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.	Cohort 2 (Chmoresistant) n=12 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
Objective Overall Response Rate	14 participants	0 participants

PRIMARY outcome

Timeframe: up to 3 years

Number of patients experiencing adverse event grade 3 or above. Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0. Adverse events possibly, probably, or definitely attributed to use of ixabepilone.

Outcome measures

Outcome measures
Measure	Cohort 1 (Chemosensitive) n=39 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.	Cohort 2 (Chmoresistant) n=12 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
Safety and Toxicity of Ixabepilone	27 participants	8 participants

SECONDARY outcome

Timeframe: up to 3 years

Duration of response was measured from the time measurement criteria are met for CR(complete response)/CRu(unconfirmed complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the 1999 international response criteria as published by Cheson, CR/CRu is defined as the disappearance of all target lesions; PR is defined as \>=50% decrease in the sum of the products of the greatest diameters; PD is defined as \>=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.

Outcome measures

Outcome measures
Measure	Cohort 1 (Chemosensitive) n=14 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.	Cohort 2 (Chmoresistant) Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
Duration of Response	291 Days Interval 162.0 to The upper limit of 95% CI is undetermined because never drops below -1.96 due to the heavy censoring.	—

SECONDARY outcome

Timeframe: up to 3 years

Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.

Outcome measures

Outcome measures
Measure	Cohort 1 (Chemosensitive) n=39 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.	Cohort 2 (Chmoresistant) n=12 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
Overall Survival	501 Days Interval 340.0 to The upper limit of 95% CI is undetermined because never drops below -1.96 due to the heavy censoring.	98 Days Interval 67.0 to The upper limit of 95% CI is undetermined because never drops below -1.96 due to the heavy censoring.

SECONDARY outcome

Timeframe: up to 3 years

Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as \>=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.

Outcome measures

Outcome measures
Measure	Cohort 1 (Chemosensitive) n=39 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.	Cohort 2 (Chmoresistant) n=12 Participants Ixabepilone was administered intravenously at a dose of 20 mg/m\^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
Time to Progression	112 Days Interval 56.0 to 340.0	84 Days Interval 67.0 to The upper limit of 95% CI is undetermined because never drops below -1.96 due to the heavy censoring.

Adverse Events

Ixabeilone for Relapsed Aggressive NHL

Serious events: 11 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ixabeilone for Relapsed Aggressive NHL n=51 participants at risk
Metabolism and nutrition disorders Dehydration	3.9% 2/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Gastrointestinal disorders Diarrhea	2.0% 1/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Metabolism and nutrition disorders Hypokalemia	2.0% 1/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Infections and infestations Infections and infestations - Other, specify	3.9% 2/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Infections and infestations Lung infection	2.0% 1/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Musculoskeletal and connective tissue disorders Myalgia	2.0% 1/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Investigations Neutrophil count decreased	3.9% 2/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Cardiac disorders Palpitations	2.0% 1/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Nervous system disorders Peripheral motor neuropathy	2.0% 1/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Nervous system disorders Peripheral sensory neuropathy	2.0% 1/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Nervous system disorders Syncope	2.0% 1/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Vascular disorders Thromboembolic event	2.0% 1/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Gastrointestinal disorders Vomiting	2.0% 1/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.

Other adverse events

Other adverse events
Measure	Ixabeilone for Relapsed Aggressive NHL n=51 participants at risk
Nervous system disorders Peripheral sensory neuropathy	62.7% 32/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
General disorders Fatigue	60.8% 31/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Investigations White blood cell decreased	58.8% 30/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Gastrointestinal disorders Nausea	47.1% 24/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Blood and lymphatic system disorders Anemia	51.0% 26/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Metabolism and nutrition disorders Hyperglycemia	15.7% 8/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Gastrointestinal disorders Diarrhea	35.3% 18/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Investigations Platelet count decreased	37.3% 19/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Investigations Neutrophil count decreased	41.2% 21/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Metabolism and nutrition disorders Anorexia	29.4% 15/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Gastrointestinal disorders Constipation	23.5% 12/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Musculoskeletal and connective tissue disorders Myalgia	25.5% 13/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Investigations Lymphocyte count decreased	25.5% 13/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Skin and subcutaneous tissue disorders Alopecia	21.6% 11/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Investigations Aspartate aminotransferase increased	17.6% 9/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
General disorders Edema limbs	5.9% 3/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Gastrointestinal disorders Vomiting	17.6% 9/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 3/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Investigations Alanine aminotransferase increased	11.8% 6/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Metabolism and nutrition disorders Hypocalcemia	7.8% 4/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Infections and infestations Infections and infestations - Other, specify	9.8% 5/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Metabolism and nutrition disorders Hypoalbuminemia	5.9% 3/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Nervous system disorders Dizziness	11.8% 6/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.8% 6/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Investigations Weight loss	7.8% 4/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Nervous system disorders Peripheral motor neuropathy	13.7% 7/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Musculoskeletal and connective tissue disorders Arthralgia	9.8% 5/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Metabolism and nutrition disorders Hyponatremia	5.9% 3/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
General disorders Pain	7.8% 4/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Investigations Alkaline phosphatase increased	5.9% 3/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Musculoskeletal and connective tissue disorders Bone pain	5.9% 3/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
General disorders Fever	7.8% 4/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Nervous system disorders Dysgeusia	9.8% 5/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
General disorders Injection site reaction	7.8% 4/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Metabolism and nutrition disorders Hyperkalemia	7.8% 4/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.9% 3/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Investigations Creatinine increased	5.9% 3/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
Metabolism and nutrition disorders Dehydration	7.8% 4/51 Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.

Additional Information

Dr. Sonali M. Smith

University of Chicago Medical Center

Phone: 773-834-2895

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60