E7389 (eribulin mesylate) given at a dose of 1.4 mg/m^2 as a 2 to 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle.
The Treatment Phase will include six cycles.\nPatients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.
"},{"op":"replace","path":"/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0","value":"Eribulin mesylate"},{"op":"replace","path":"/protocolSection/armsInterventionsModule/interventions/1/name","value":"Ixabepilone"},{"op":"replace","path":"/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0","value":"Ixabepilone"},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/measure","value":"Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs)"},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","value":"From administration of first dose up to approximately 5 years"},{"op":"add","path":"/protocolSection/outcomesModule/primaryOutcomes/0/description","value":"Neuropathy AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and coded according to the current version of the Medical Dictionary for Regulatory Activities (MedDRA).\nNeuropathy AEs included the broad list of preferred terms (PTs) defined in the Standard MedDRA Query for Neuropathy and the following additional PTs: neuropathy, hyperesthesia, painful response to normal stimuli, pallanesthesia, and allodynia.\nIf the post-baseline maximum CTCAE grade of the combined term "neuropathy" was greater than the baseline maximum CTCAE grade of the combined term, then the event was considered as treatment emergent neuropathy adverse events per CTCAE grade.\nFor a single participant, 1) a neuropathy AE occurring more than once during the study, whether defined with the same or different MedDRA PTs, was counted only once, 2) a neuropathy AE with different CTCAE grades had only the highest grade AE counted."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/measure","value":"Percentage of Participants With an Incidence of Treatment-emergent Myalgia/Arthralgia"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","value":"From administration of first dose up to approximately 5 years"},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/description","value":"The incidence rate of TE myalgia/arthralgia was calculated as the percent of participants with TE myalgia/arthralgia.\nA participant who had an arthralgia or myalgia AE more than once over the course of the study was counted only once in the incidence calculation for myalgia/arthralgia AEs.\nA participant who had myalgia/arthralgia AEs with different CTCAE grades was counted with the highest CTCAE grade over the course of the evaluation period.\nIf the post-baseline CTCAE grade of the combined term "Myalgia/Arthralgia" was greater than the baseline maximum CTCAE grade of the combined term, the participant had TE myalgia/arthralgia.\nThe 2-sided 95% confidence interval (CI) for incidence rate of TE myalgia/arthralgia was calculated using the Clopper-Pearson method (i.e., the exact method) for each treatment group."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/measure","value":"Change From Baseline in Vibration Perception Threshold (VPT)"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","value":"Baseline, Treatment Phase: Cycles 2 to 6 (Day 1); Extension Phase: Cycle 9 Day 1, Cycle 12 Day 1, Cycle 15 Day 1 (Each Cycle length=21 days), End of Treatment, Post-treatment Follow-up, Worst Post-baseline result (Up to approximately 5 years)"},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/description","value":"The participant-reported questionnaire was used to compare the incidence and severity of neuropathy AEs.\nSensory and motor scores were to be analyzed separately using a generalized linear model.\nSeparate subgroup analyses were performed by each stratification variable.\nVPAT was measured using a Vibratron II device (Physitemp, Inc.) and a modified Two Alternative Forced Choice psychophysical algorithm.\nVPT was assessed on the ventral surface of the distal index finger (side opposite the nail), contralateral to the side of the mastectomy or primary disease and on the distal fleshy pad of both the right and left great toes (side opposite the nail).\nIf the mastectomy was bilateral, the index finger on the side without axillary lymph node dissection was tested.\nData ranged from 0 (invalid) to 20 vu.\nA lower VPT indicated a greater sensitivity."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/measure","value":"Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 1 (Sensory)"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame","value":"Baseline up to approximately 5 years"},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/description","value":"The PNQ consisted of 3 parts; Item 1 (sensory) measured numbness, pain, burning or tingling in hands or feet, Item 2 (motor) measured weakness in arms or legs, and Item 3 (activities) measured activities that interfered with daily life.\nThe participant was told that there was no right or wrong answer and their answer should reflect how they currently felt since last completing the PNQ.\nSensory scores were analyzed separately.\nLetter scores (A= none, B=mild, C=moderate, D=moderate to severe, and E=severe) for PNQ were converted to numeric scores A (none)=0, B (mild)=1, C (moderate)=2, D (moderate to severe)=3 and E (severe)=4).\nTotal scores ranged from 0 (minimum severity) to 10 (maximum severity).\nHigher scores indicated greater severity.\nNeuropathy AEs that were sensory were evaluated with the PNQ Item 1 (sensory).\nCategories where no participant showed any shift from baseline to post-baseline for both the arms were not included in the presentation."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/3/measure","value":"Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 2 (Motor)"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame","value":"Baseline up to approximately 5 years"},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/3/description","value":"The PNQ consisted of 3 parts; Item 1 (sensory) measured numbness, pain, burning or tingling in hands or feet, Item 2 (motor) measured weakness in arms or legs, and Item 3 (activities) measured activities that interfered with daily life.\nThe participant was told that there was no right or wrong answer and their answer should reflect how they currently felt since last completing the PNQ.\nMotor scores were analyzed separately.\nLetter scores (A= none, B=mild, C=moderate, D=moderate to severe, and E=severe) for PNQ were converted to numeric scores A (none)=0, B (mild)=1, C (moderate)=2, D (moderate to severe)=3 and E (severe)=4).\nTotal scores ranged from 0 (minimum severity) to 10 (maximum severity).\nHigher scores indicated greater severity.\nNeuropathy AEs that were motor were evaluated with the PNQ Item 2 (motor).\nCategories where no participant showed any shift from baseline to post-baseline for both the arms were not included in the presentation."},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/4","value":{"description":"The PNQ consisted of 3 parts; Item 1 (sensory) measured numbness, pain, burning or tingling in hands or feet, Item 2 (motor) measured weakness in arms or legs, and Item 3 (activities) measured activities that interfered with daily life.\nSensory scores, motor scores and composite scores were analyzed separately.\nFor both item 1 and item 2, letter scores (A=none, B=mild, C=moderate, D=moderate to severe, and E=severe) for PNQ were converted to numeric scores A(none)=0, B(mild)=1, C(moderate)=2, D(moderate to severe)=3 and E (severe)=4.\nTotal scores ranged from 0 (minimum severity) to 10 (maximum severity).\nHigher scores indicated greater severity.\nPNQ composite score was defined as the worst of Item 1 and Item 2 score.\nIf neither Item 1 or item 2 score was D or E, but if a box was checked in Item 3, PNQ composite score would be D. Categories where no participant showed any shift from baseline to post-baseline for both the arms were not included in the presentation.","measure":"Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Composite Score","timeFrame":"Baseline up to approximately 5 years"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/5","value":{"description":"ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0\nfor target lesions assessed by magnetic resonance imaging and computed tomography and investigator assessment.\nParticipants with unknown or missing responses were treated as non-responders.\nCR was defined as disappearance of all target lesions.\nPR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.\nORR=CR+PR, was presented with 2-sided 95% confidence interval (CI) by the method of Clopper-Pearson method for calculating the exact binomial intervals.","measure":"Objective Response Rate (ORR)","timeFrame":"From date of treatment start until disease progression (PD) (Up to approximately 5 years)"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/6","value":{"description":"PFS was defined as the time from randomization until PD or death due to any cause as determined by the investigator.\nDisease progression per RECIST v1.0 was defined as at least a 20% relative increase and 5 millimeter absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.\nThe duration of PFS was calculated as the end date minus date of first drug plus 1.\nFor participants who did not have an event (those lost to follow-up or who had not progressed at the date of data cut-off) PFS was censored.\nThe median PFS and corresponding 95% CI was estimated for each treatment group using the Kaplan-Meier method.","measure":"Progression-Free Survival (PFS)","timeFrame":"From date of treatment start until the date of PD or death from any cause (Up to approximately 5 years)"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/7","value":{"description":"CBR was defined as the number of participants (CR + PR + stable disease (SD) greater than or equal to 6 months) divided by the number of participants in the analysis population.\nThe 95% CI was generated for the clinical benefit rate for each treatment group, and it was based on the Clopper-Pearson method for calculating the exact binomial intervals.","measure":"Clinical Benefit Rate (CBR)","timeFrame":"From date of treatment start until PD or death from any cause, whichever occurred first (Up to approximately 5 years)"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/8","value":{"description":"DoR was defined as the time from first documented CR or PR until PD or death from any cause.\nIt was measured from the time that measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent or PD was objectively documented.\nIt was defined for participants with a confirmed CR or a confirmed PR.\nParticipants without progressive disease or death were censored.\nMedian duration and 95% CI of the median were estimated for each treatment group, using the Kaplan-Meier method.","measure":"Duration of Response (DoR)","timeFrame":"From date of first CR or PR until the first documentation of PD or date of death (Up to approximately 5 years)"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/9","value":{"description":"General safety was assessed by monitoring all TEAEs and SAEs.\nTEAEs were reported at a frequency of 0% or greater in the study population.","measure":"Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Eribulin and Ixabepilone","timeFrame":"For each participant, from the first dose till 42 days after the last dose of study treatment (Up to approximately 5 years)"}},{"op":"remove","path":"/annotationSection"},{"op":"replace","path":"/hasResults","value":true},{"op":"add","path":"/resultsSection","value":{"adverseEventsModule":{"description":"Treatment-emergent adverse events were reported.\nAll adverse events were graded using National Cancer Institute Common Terminology Criteria (NCI CTCAE) version 3.0.\nThe SAS included all randomized participants who received at least one dose of study medication and who had at least one safety assessment following the first dose of study medication.\nOf 104 participants randomized into the study, 3 did not receive treatment, 1 in the E7389 Treatment Group and 2 in the Ixabepilone Treatment Group.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":51,"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"EG000","otherNumAffected":51,"otherNumAtRisk":51,"seriousNumAffected":19,"seriousNumAtRisk":51,"title":"Eribulin Mesylate"},{"deathsNumAffected":2,"deathsNumAtRisk":50,"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"EG001","otherNumAffected":50,"otherNumAtRisk":50,"seriousNumAffected":17,"seriousNumAtRisk":50,"title":"Ixabepilone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":51},{"groupId":"EG001","numAffected":14,"numAtRisk":50}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":51},{"groupId":"EG001","numAffected":10,"numAtRisk":50}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51},{"groupId":"EG001","numAffected":7,"numAtRisk":50}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":51},{"groupId":"EG001","numAffected":27,"numAtRisk":50}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":51},{"groupId":"EG001","numAffected":12,"numAtRisk":50}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":51},{"groupId":"EG001","numAffected":15,"numAtRisk":50}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":51},{"groupId":"EG001","numAffected":10,"numAtRisk":50}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51},{"groupId":"EG001","numAffected":9,"numAtRisk":50}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":6,"numAtRisk":50}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":5,"numAtRisk":50}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":4,"numAtRisk":50}],"term":"Abdominal pain lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":51},{"groupId":"EG001","numAffected":27,"numAtRisk":50}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":51},{"groupId":"EG001","numAffected":29,"numAtRisk":50}],"term":"Fatigue / Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":51},{"groupId":"EG001","numAffected":5,"numAtRisk":50}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":5,"numAtRisk":50}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":4,"numAtRisk":50}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":4,"numAtRisk":50}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51},{"groupId":"EG001","numAffected":2,"numAtRisk":50}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":51},{"groupId":"EG001","numAffected":2,"numAtRisk":50}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51},{"groupId":"EG001","numAffected":4,"numAtRisk":50}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":51},{"groupId":"EG001","numAffected":13,"numAtRisk":50}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51},{"groupId":"EG001","numAffected":6,"numAtRisk":50}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51},{"groupId":"EG001","numAffected":4,"numAtRisk":50}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":51},{"groupId":"EG001","numAffected":22,"numAtRisk":50}],"term":"Myalgia / Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":51},{"groupId":"EG001","numAffected":17,"numAtRisk":50}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":51},{"groupId":"EG001","numAffected":5,"numAtRisk":50}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51},{"groupId":"EG001","numAffected":7,"numAtRisk":50}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51},{"groupId":"EG001","numAffected":2,"numAtRisk":50}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":5,"numAtRisk":50}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":4,"numAtRisk":50}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":4,"numAtRisk":50}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":11,"numAtRisk":50}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":51},{"groupId":"EG001","numAffected":23,"numAtRisk":50}],"term":"Peripheral Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":51},{"groupId":"EG001","numAffected":15,"numAtRisk":50}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":51},{"groupId":"EG001","numAffected":6,"numAtRisk":50}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51},{"groupId":"EG001","numAffected":4,"numAtRisk":50}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51},{"groupId":"EG001","numAffected":2,"numAtRisk":50}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51},{"groupId":"EG001","numAffected":8,"numAtRisk":50}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51},{"groupId":"EG001","numAffected":2,"numAtRisk":50}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":51},{"groupId":"EG001","numAffected":6,"numAtRisk":50}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51},{"groupId":"EG001","numAffected":13,"numAtRisk":50}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":5,"numAtRisk":50}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":4,"numAtRisk":50}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":51},{"groupId":"EG001","numAffected":21,"numAtRisk":50}],"term":"Alopecia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Lower limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Radiation pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Hypovolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":2,"numAtRisk":50}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Myalgia / Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Intervertebral disc protrusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Metastases to central nervous system"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Malignant neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Malignant pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Metastases to meninges"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Reversible posterior leukoencephalopathy syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Peripheral Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Pleural effusion"}],"timeFrame":"For each participant, from the first dose till 42 days after the last dose of study treatment (Up to approximately 5 years)"},"baselineCharacteristicsModule":{"denoms":[{"counts":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"101"}],"units":"Participants"}],"groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"BG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"BG001","title":"Ixabepilone"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"9.83","value":"52.2"},{"groupId":"BG001","spread":"10.68","value":"56.9"},{"groupId":"BG002","spread":"10.49","value":"54.5"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"101"}]}],"title":"Female"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"title":"Male"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex/Gender, Customized","unitOfMeasure":"Participants"}],"populationDescription":"SAS included all randomized participants who received at least one dose of study medication and who had at least one safety assessment following the first dose of study medication."},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true},"pointOfContact":{"email":"esi_oncmedinfo@eisai.com","organization":"Eisai Inc.","phone":"888-274-2378","phoneExt":"+1","title":"Eisai Medical Information"}},"outcomeMeasuresModule":{"outcomeMeasures":[{"analyses":[{"ciLowerLimit":"-36.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.4","estimateComment":"Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"=0.0941","pValueComment":"The two treatment groups were compared, controlling for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (less than or equal to 3 or greater than 3), with both covariates included as binary variables.","paramType":"Difference in proportions","paramValue":"-16.7","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"20.8","upperLimit":"47.9","value":"33.3"},{"groupId":"OG001","lowerLimit":"35.5","upperLimit":"64.5","value":"50.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"50"}],"units":"Participants"}],"description":"Neuropathy AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and coded according to the current version of the Medical Dictionary for Regulatory Activities (MedDRA).\nNeuropathy AEs included the broad list of preferred terms (PTs) defined in the Standard MedDRA Query for Neuropathy and the following additional PTs: neuropathy, hyperesthesia, painful response to normal stimuli, pallanesthesia, and allodynia.\nIf the post-baseline maximum CTCAE grade of the combined term "neuropathy" was greater than the baseline maximum CTCAE grade of the combined term, then the event was considered as treatment emergent neuropathy adverse events per CTCAE grade.\nFor a single participant, 1) a neuropathy AE occurring more than once during the study, whether defined with the same or different MedDRA PTs, was counted only once, 2) a neuropathy AE with different CTCAE grades had only the highest grade AE counted.","dispersionType":"95% Confidence Interval","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"NUMBER","populationDescription":"SAS included all randomized participants who received at least one dose of study medication and who had at least one safety assessment following the first dose of study medication.","reportingStatus":"POSTED","timeFrame":"From administration of first dose up to approximately 5 years","title":"Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs)","type":"PRIMARY","unitOfMeasure":"Percentage of participants"},{"analyses":[{"ciLowerLimit":"-36.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.3","estimateComment":"Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0492","pValueComment":"Controlled for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3), with both covariates included as binary variables.","paramType":"Difference in proportions","paramValue":"-18.4","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.8","upperLimit":"33.1","value":"19.6"},{"groupId":"OG001","lowerLimit":"24.7","upperLimit":"52.8","value":"38.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"50"}],"units":"Participants"}],"description":"The incidence rate of TE myalgia/arthralgia was calculated as the percent of participants with TE myalgia/arthralgia.\nA participant who had an arthralgia or myalgia AE more than once over the course of the study was counted only once in the incidence calculation for myalgia/arthralgia AEs.\nA participant who had myalgia/arthralgia AEs with different CTCAE grades was counted with the highest CTCAE grade over the course of the evaluation period.\nIf the post-baseline CTCAE grade of the combined term "Myalgia/Arthralgia" was greater than the baseline maximum CTCAE grade of the combined term, the participant had TE myalgia/arthralgia.\nThe 2-sided 95% confidence interval (CI) for incidence rate of TE myalgia/arthralgia was calculated using the Clopper-Pearson method (i.e., the exact method) for each treatment group.","dispersionType":"95% Confidence Interval","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"NUMBER","populationDescription":"SAS included all randomized participants who received at least one dose of study medication and who had at least one safety assessment following the first dose of study medication.","reportingStatus":"POSTED","timeFrame":"From administration of first dose up to approximately 5 years","title":"Percentage of Participants With an Incidence of Treatment-emergent Myalgia/Arthralgia","type":"SECONDARY","unitOfMeasure":"Percentage of participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.117","value":"1.50"},{"groupId":"OG001","spread":"1.373","value":"1.96"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"50"}],"units":"Participants"}],"title":"Index Finger, Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.196","value":"0.13"},{"groupId":"OG001","spread":"1.641","value":"-0.09"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"42"}],"units":"Participants"}],"title":"Index Finger, Cycle 2 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.478","value":"0.31"},{"groupId":"OG001","spread":"1.762","value":"-0.22"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"29"}],"units":"Participants"}],"title":"Index Finger, Cycle 3 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.218","value":"0.67"},{"groupId":"OG001","spread":"1.588","value":"-0.14"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"Index Finger, Cycle 4 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.291","value":"0.93"},{"groupId":"OG001","spread":"1.828","value":"0.10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"20"}],"units":"Participants"}],"title":"Index Finger, Cycle 5 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.515","value":"1.86"},{"groupId":"OG001","spread":"2.213","value":"-0.07"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"Index Finger, Cycle 6 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.221","value":"1.94"},{"groupId":"OG001","spread":"1.144","value":"0.35"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"title":"Index Finger, Cycle 9 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.816","value":"0.50"},{"groupId":"OG001","spread":"0.354","value":"0.65"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Index Finger, Cycle 12 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.906","value":"0.90"},{"comment":"As only one participant was available here, so standard deviation could not be calculated.","groupId":"OG001","spread":"NA","value":"1.30"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Index Finger, Cycle 15 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.108","value":"1.23"},{"groupId":"OG001","spread":"1.388","value":"0.35"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"34"}],"units":"Participants"}],"title":"Index finger, End of Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.727","value":"1.34"},{"groupId":"OG001","spread":"0.991","value":"0.58"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"Index finger, Post-treatment follow-up"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.491","value":"1.95"},{"groupId":"OG001","spread":"1.721","value":"0.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"45"}],"units":"Participants"}],"title":"Index finger, Worst post-baseline result"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.393","value":"5.22"},{"groupId":"OG001","spread":"3.525","value":"6.60"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"title":"Great toe, Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.760","value":"0.15"},{"groupId":"OG001","spread":"1.988","value":"0.08"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"title":"Great toe, Cycle 2 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.110","value":"0.49"},{"groupId":"OG001","spread":"2.589","value":"0.20"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Great toe, Cycle 3 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.037","value":"0.89"},{"groupId":"OG001","spread":"3.679","value":"0.82"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"24"}],"units":"Participants"}],"title":"Great toe, Cycle 4 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.899","value":"1.08"},{"groupId":"OG001","spread":"3.645","value":"0.54"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"title":"Great toe, Cycle 5 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.873","value":"2.28"},{"groupId":"OG001","spread":"3.371","value":"0.39"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"17"}],"units":"Participants"}],"title":"Great toe, Cycle 6 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.711","value":"2.69"},{"groupId":"OG001","spread":"2.417","value":"1.34"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"title":"Great toe, Cycle 9 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.992","value":"1.23"},{"groupId":"OG001","spread":"0.636","value":"5.35"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Great toe, Cycle 12 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.070","value":"1.12"},{"groupId":"OG001","value":"3.40"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Great toe, Cycle 15 (Day 1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.208","value":"1.39"},{"groupId":"OG001","spread":"2.682","value":"1.71"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"34"}],"units":"Participants"}],"title":"Great toe, End of treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.422","value":"3.34"},{"groupId":"OG001","spread":"3.371","value":"1.53"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"Great toe, Post-treatment follow-up"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.762","value":"2.39"},{"groupId":"OG001","spread":"2.916","value":"2.16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"title":"Great toe, Worst post-baseline results"}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"50"}],"units":"Participants"}],"description":"The participant-reported questionnaire was used to compare the incidence and severity of neuropathy AEs.\nSensory and motor scores were to be analyzed separately using a generalized linear model.\nSeparate subgroup analyses were performed by each stratification variable.\nVPAT was measured using a Vibratron II device (Physitemp, Inc.) and a modified Two Alternative Forced Choice psychophysical algorithm.\nVPT was assessed on the ventral surface of the distal index finger (side opposite the nail), contralateral to the side of the mastectomy or primary disease and on the distal fleshy pad of both the right and left great toes (side opposite the nail).\nIf the mastectomy was bilateral, the index finger on the side without axillary lymph node dissection was tested.\nData ranged from 0 (invalid) to 20 vu.\nA lower VPT indicated a greater sensitivity.","dispersionType":"Standard Deviation","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"MEAN","populationDescription":"SAS included all randomized participants who received at least one dose of study medication and who had at least one safety assessment following the first dose of study medication.\nHere "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.","reportingStatus":"POSTED","timeFrame":"Baseline, Treatment Phase: Cycles 2 to 6 (Day 1); Extension Phase: Cycle 9 Day 1, Cycle 12 Day 1, Cycle 15 Day 1 (Each Cycle length=21 days), End of Treatment, Post-treatment Follow-up, Worst Post-baseline result (Up to approximately 5 years)","title":"Change From Baseline in Vibration Perception Threshold (VPT)","type":"SECONDARY","unitOfMeasure":"Vibration units (vu)"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"7"}]}],"title":"A (Baseline) to A (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"}]}],"title":"A (Baseline) to B (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"}]}],"title":"A (Baseline) to C (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]}],"title":"A (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"A (Baseline) to E (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"B (Baseline) to A (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"}]}],"title":"B (Baseline) to B (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"8"}]}],"title":"B (Baseline) to C (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"5"}]}],"title":"B (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"B (Baseline) to E (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"C (Baseline) to B (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"title":"C (Baseline) to C (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"C (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"D (Baseline) to D (Worst Post-baseline)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"46"}],"units":"Participants"}],"description":"The PNQ consisted of 3 parts; Item 1 (sensory) measured numbness, pain, burning or tingling in hands or feet, Item 2 (motor) measured weakness in arms or legs, and Item 3 (activities) measured activities that interfered with daily life.\nThe participant was told that there was no right or wrong answer and their answer should reflect how they currently felt since last completing the PNQ.\nSensory scores were analyzed separately.\nLetter scores (A= none, B=mild, C=moderate, D=moderate to severe, and E=severe) for PNQ were converted to numeric scores A (none)=0, B (mild)=1, C (moderate)=2, D (moderate to severe)=3 and E (severe)=4).\nTotal scores ranged from 0 (minimum severity) to 10 (maximum severity).\nHigher scores indicated greater severity.\nNeuropathy AEs that were sensory were evaluated with the PNQ Item 1 (sensory).\nCategories where no participant showed any shift from baseline to post-baseline for both the arms were not included in the presentation.","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"SAS included all randomized participants who received at least one dose of study medication and who had at least one safety assessment following the first dose of study medication.\nHere "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Baseline up to approximately 5 years","title":"Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 1 (Sensory)","type":"SECONDARY","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"12"}]}],"title":"A (Baseline) to A (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"3"}]}],"title":"A (Baseline) to B (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"6"}]}],"title":"A (Baseline) to C (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"7"}]}],"title":"A (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"A (Baseline) to E (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}]}],"title":"B (Baseline) to B (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"}]}],"title":"B (Baseline) to C (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"}]}],"title":"B (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"C (Baseline) to C (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"}]}],"title":"C (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"D (Baseline) to A (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"D (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"D (Baseline) to E (Worst Post-baseline)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"46"}],"units":"Participants"}],"description":"The PNQ consisted of 3 parts; Item 1 (sensory) measured numbness, pain, burning or tingling in hands or feet, Item 2 (motor) measured weakness in arms or legs, and Item 3 (activities) measured activities that interfered with daily life.\nThe participant was told that there was no right or wrong answer and their answer should reflect how they currently felt since last completing the PNQ.\nMotor scores were analyzed separately.\nLetter scores (A= none, B=mild, C=moderate, D=moderate to severe, and E=severe) for PNQ were converted to numeric scores A (none)=0, B (mild)=1, C (moderate)=2, D (moderate to severe)=3 and E (severe)=4).\nTotal scores ranged from 0 (minimum severity) to 10 (maximum severity).\nHigher scores indicated greater severity.\nNeuropathy AEs that were motor were evaluated with the PNQ Item 2 (motor).\nCategories where no participant showed any shift from baseline to post-baseline for both the arms were not included in the presentation.","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"SAS included all randomized participants who received at least one dose of study medication and who had at least one safety assessment following the first dose of study medication.\nHere "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Baseline up to approximately 5 years","title":"Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 2 (Motor)","type":"SECONDARY","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"}]}],"title":"A (Baseline) to A (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"1"}]}],"title":"A (Baseline) to B (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}]}],"title":"A (Baseline) to C (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"}]}],"title":"A (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"A (Baseline) to E (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"B (Baseline) to A (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"}]}],"title":"B (Baseline) to B (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"}]}],"title":"B (Baseline) to C (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"6"}]}],"title":"B (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"C (Baseline) to C (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}],"title":"C (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"D (Baseline) to A (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}],"title":"D (Baseline) to C (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"}]}],"title":"D (Baseline) to D (Worst Post-baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"D (Baseline) to E (Worst Post-baseline)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"46"}],"units":"Participants"}],"description":"The PNQ consisted of 3 parts; Item 1 (sensory) measured numbness, pain, burning or tingling in hands or feet, Item 2 (motor) measured weakness in arms or legs, and Item 3 (activities) measured activities that interfered with daily life.\nSensory scores, motor scores and composite scores were analyzed separately.\nFor both item 1 and item 2, letter scores (A=none, B=mild, C=moderate, D=moderate to severe, and E=severe) for PNQ were converted to numeric scores A(none)=0, B(mild)=1, C(moderate)=2, D(moderate to severe)=3 and E (severe)=4.\nTotal scores ranged from 0 (minimum severity) to 10 (maximum severity).\nHigher scores indicated greater severity.\nPNQ composite score was defined as the worst of Item 1 and Item 2 score.\nIf neither Item 1 or item 2 score was D or E, but if a box was checked in Item 3, PNQ composite score would be D. Categories where no participant showed any shift from baseline to post-baseline for both the arms were not included in the presentation.","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"SAS included all randomized participants who received at least one dose of study medication and who had at least one safety assessment following the first dose of study medication.\nHere "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Baseline up to approximately 5 years","title":"Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Composite Score","type":"SECONDARY","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.9","upperLimit":"28.1","value":"15.4"},{"groupId":"OG001","lowerLimit":"1.2","upperLimit":"15.9","value":"5.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"52"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0\nfor target lesions assessed by magnetic resonance imaging and computed tomography and investigator assessment.\nParticipants with unknown or missing responses were treated as non-responders.\nCR was defined as disappearance of all target lesions.\nPR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.\nORR=CR+PR, was presented with 2-sided 95% confidence interval (CI) by the method of Clopper-Pearson method for calculating the exact binomial intervals.","dispersionType":"95% Confidence Interval","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"NUMBER","populationDescription":"Full analysis set (FAS) included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From date of treatment start until disease progression (PD) (Up to approximately 5 years)","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"80.0","upperLimit":"129.0","value":"104"},{"groupId":"OG001","lowerLimit":"73.0","upperLimit":"186.0","value":"95"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"52"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization until PD or death due to any cause as determined by the investigator.\nDisease progression per RECIST v1.0 was defined as at least a 20% relative increase and 5 millimeter absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.\nThe duration of PFS was calculated as the end date minus date of first drug plus 1.\nFor participants who did not have an event (those lost to follow-up or who had not progressed at the date of data cut-off) PFS was censored.\nThe median PFS and corresponding 95% CI was estimated for each treatment group using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"MEDIAN","populationDescription":"FAS analysis set included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From date of treatment start until the date of PD or death from any cause (Up to approximately 5 years)","title":"Progression-Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Days"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.6","upperLimit":"41.0","value":"26.9"},{"groupId":"OG001","lowerLimit":"11.1","upperLimit":"34.7","value":"21.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"52"}],"units":"Participants"}],"description":"CBR was defined as the number of participants (CR + PR + stable disease (SD) greater than or equal to 6 months) divided by the number of participants in the analysis population.\nThe 95% CI was generated for the clinical benefit rate for each treatment group, and it was based on the Clopper-Pearson method for calculating the exact binomial intervals.","dispersionType":"95% Confidence Interval","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"NUMBER","populationDescription":"FAS analysis set included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From date of treatment start until PD or death from any cause, whichever occurred first (Up to approximately 5 years)","title":"Clinical Benefit Rate (CBR)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"60.0","upperLimit":"246","value":"169"},{"comment":"Here, Median and 95% upper and lower CI could not be estimated due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"DoR was defined as the time from first documented CR or PR until PD or death from any cause.\nIt was measured from the time that measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent or PD was objectively documented.\nIt was defined for participants with a confirmed CR or a confirmed PR.\nParticipants without progressive disease or death were censored.\nMedian duration and 95% CI of the median were estimated for each treatment group, using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"MEDIAN","populationDescription":"FAS analysis set included all randomized participants.\nNumber of participants analyzed who had CR or PR.","reportingStatus":"POSTED","timeFrame":"From date of first CR or PR until the first documentation of PD or date of death (Up to approximately 5 years)","title":"Duration of Response (DoR)","type":"SECONDARY","unitOfMeasure":"Days"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"100.0"},{"groupId":"OG001","value":"100.0"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37.3"},{"groupId":"OG001","value":"34.0"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"50"}],"units":"Participants"}],"description":"General safety was assessed by monitoring all TEAEs and SAEs.\nTEAEs were reported at a frequency of 0% or greater in the study population.","groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"OG001","title":"Ixabepilone"}],"paramType":"NUMBER","populationDescription":"SAS included all randomized participants who received at least one dose of study medication and who had at least one safety assessment following the first dose of study medication.","reportingStatus":"POSTED","timeFrame":"For each participant, from the first dose till 42 days after the last dose of study treatment (Up to approximately 5 years)","title":"Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Eribulin and Ixabepilone","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}]},"participantFlowModule":{"groups":[{"description":"Eribulin mesylate was given at a dose of 1.4 milligram per square meter (mg/m^2) as a 2 to 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"FG000","title":"Eribulin Mesylate"},{"description":"Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases.\nThe Treatment Phase included six cycles.\nFollowing the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).","id":"FG001","title":"Ixabepilone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"15"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Participant choice"},{"reasons":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"26"}],"type":"Progression of disease"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal of consent"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"52"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"50"}],"type":"Safety Analysis Set (SAS)"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"52"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"127 participants were screened.\nOf these, 104 participants were enrolled and randomized into the study and 23 participants were screen failures (19 failed to meet entrance criteria, 3 failed due to other reason, and 1 failed due to consent withdrawal)."}}}],"provenance":{"from_snapshot_hash":"081dc070acb1adc23a9fa9344ad85e211c8608ee32cbab502dc42d62a174b882","materiality_event_hash":"bd48f0b013719623c5000942c89d4eb76e341c801e5c2c6560313863975ae7ff","patch_hash":"bd976e22125a0b5bc22eda0cfb1ab82a12f17854a9250cbd06038e8a1f03118b","patch_raw_hash":"1ad5c8d1e3e4ab4ec6df275894827a56625cb6918df73636ddb5553f6062c408","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT00879086/history/8?patchToVersion=9","to_snapshot_hash":"00dd2b3e44ccf39866b684ca5cb2b4471e25e2e592e895fcf496f15071b3249a"},"review_question":"What source document explains this registry amendment, and does it change interpretation of the trial record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT00879086","nct_id":"NCT00879086"},"versions":{"from_version":8,"submitted_date":"2021-11-02","to_version":9}}