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Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT01327885
Recruitment Status : Completed
First Posted : April 4, 2011
Results First Posted : February 28, 2017
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Soft Tissue Sarcoma
Interventions Drug: Eribulin mesylate 1.4 mg/m^2 intravenous
Drug: Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
Enrollment 452
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A: Eribulin Mesylate Arm B: Dacarbazine
Hide Arm/Group Description Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle. Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Period Title: Overall Study
Started 228 224
Completed 0 0
Not Completed 228 224
Reason Not Completed
Disease progression-according to RECIST             173             165
Clinical progression             24             27
Adverse Event             14             10
Subject choice             5             10
Not specified             8             6
Withdrawal of consent from study             2             4
Not treated             1             1
Ongoing             1             1
Arm/Group Title Arm A: Eribulin Mesylate Arm B: Dacarbazine Total
Hide Arm/Group Description Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle. Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle. Total of all reporting groups
Overall Number of Baseline Participants 228 224 452
Hide Baseline Analysis Population Description
Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 228 participants 224 participants 452 participants
55.6  (11.01) 55.7  (10.35) 55.7  (10.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants 224 participants 452 participants
Female
161
  70.6%
142
  63.4%
303
  67.0%
Male
67
  29.4%
82
  36.6%
149
  33.0%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (ADI or LMS), (b) Region (Region 1: USA and Canada; or Region 2: Western Europe, Australia, Israel; or Region 3: Eastern Europe, Latin America, and Asia), and (c) Number of prior regimens for advanced soft tissue sarcoma (STS) (2 or >2 prior regimens).
Time Frame From date of treatment start until date of death from any cause, assessed up to data cutoff date (02 Jan 2015), for up to approximately 3 years 11 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.
Arm/Group Title Arm A: Eribulin Mesylate Arm B: Dacarbazine
Hide Arm/Group Description:
Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Overall Number of Participants Analyzed 228 224
Median (95% Confidence Interval)
Unit of Measure: Months
13.5
(10.9 to 15.6)
11.5
(9.6 to 13.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Eribulin Mesylate, Arm B: Dacarbazine
Comments Statistical analysis was designed to detect superiority of Arm A (eribulin) over Arm B (dacarbazine). OS was compared between the two treatment arms using a two-sided stratified log-rank test at a nominal significance level of 0.0455 (adjusted for the interim analysis). This was the primary analysis that was performed when the target number of events (~353 deaths) was observed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0169
Comments The P-value was calculated by 2-sided log-rank test as stratified by histology, geographic region, and number of prior regimens for advanced STS.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.768
Confidence Interval (2-Sided) 95%
0.618 to 0.954
Estimation Comments The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death (whichever occurred first). The date of disease progression was defined as the date of radiologic disease progression as assessed by the investigator or designee based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Participants who did not have an event (i.e., participants who were lost to follow-up or who did not progress or die at the date of data cut-off), were censored. Participants who discontinued study treatment without disease progression were censored on the date of their last radiological assessment (scan date).
Time Frame Randomization (day 1) to the date of first documentation of disease progression, or date of death (whichever occurred first)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (ITT analysis set) included all participants who were randomized.
Arm/Group Title Arm A: Eribulin Mesylate Arm B: Dacarbazine
Hide Arm/Group Description:
Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Overall Number of Participants Analyzed 228 224
Median (95% Confidence Interval)
Unit of Measure: Months
2.6
(1.9 to 2.8)
2.6
(1.8 to 2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Eribulin Mesylate, Arm B: Dacarbazine
Comments The PFS and PFS rate at 3, 6, and 12 months (95% confidence interval (CI)) was calculated using Kaplan-Meier (K-M) product-limit method and Greenwood Formula. PFS was compared between the treatment arms using two-sided stratified log-rank test, stratified by histology, geographic region, and number of prior regimens for advanced STS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.2287
Comments P-value was calculated by 2-sided log-rank test, as stratified by histology, geographic region, and number of prior regimens for advanced STS.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.877
Confidence Interval (2-Sided) 95%
0.710 to 1.085
Estimation Comments The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.
3.Secondary Outcome
Title Progression-Free Rate at 12 Weeks (PFR12wks)
Hide Description The PFR12wks was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. Tumor assessment by the investigator or designee was based on RECIST criteria 1.1.
Time Frame From date of treatment start until Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (ITT analysis set) included all participants who were randomized.
Arm/Group Title Arm A: Eribulin Mesylate Arm B: Dacarbazine
Hide Arm/Group Description:
Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Overall Number of Participants Analyzed 228 224
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
33.3
(27.2 to 39.9)
28.6
(22.8 to 35.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Eribulin Mesylate, Arm B: Dacarbazine
Comments The PFR12wks was compared between the treatment arms using stratified Cochran-Mantal-Haenszel (CMH) chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.253
Comments The P-value was calculated using the stratified CMH method, the stratified factors included histology, geographic region, and number of prior regimens for advanced STS.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.8 to 1.9
Estimation Comments The Odds Ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of the Odds Ratio is based on asymptotic normal approximation.
4.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description CBR was defined as the percentage of participants who have best overall response (BOR) of CR, or PR, or duration of stable disease (dSD) greater than or equal to 11 weeks, between Arm A and Arm B. CBR was estimated by treatment arm based on the tumor response evaluation performed by the PI or designee according to RECIST 1.1. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.
Time Frame From date of treatment start (Day 1) until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff (02 Jan 2015), for up to approximately 3 years 11 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (ITT analysis set) included all participants who were randomized.
Arm/Group Title Arm A: Eribulin Mesylate Arm B: Dacarbazine
Hide Arm/Group Description:
Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Overall Number of Participants Analyzed 228 224
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
46.1
(39.5 to 52.8)
47.8
(41.1 to 54.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Eribulin Mesylate, Arm B: Dacarbazine
Comments The PFR12wks was compared between the treatment arms using stratified CMH chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.741
Comments The P-value was calculated using the CMH method. The stratified factors were histology, geographic region, and number of prior regimens for advanced STS.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.7 to 1.4
Estimation Comments The Odds Ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of Odds Ratio is based on asymptotic normal approximation.
Time Frame From date of first dose up to 30 days after the last dose of study treatment, or up to data cutoff date (02 Jan 2015), up to approximately 3 years 11 months.
Adverse Event Reporting Description Treatment-emergent adverse events were reported. Safety analysis set included all participants who were randomized, received at least one dose of study treatment, and had at least one post-baseline safety evaluation. All treated participants were included in the safety analysis set and analyzed in the treatment arm for the study drug they actually received.
 
Arm/Group Title Arm A: Eribulin Mesylate Arm B: Dacarbazine
Hide Arm/Group Description Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle. Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
All-Cause Mortality
Arm A: Eribulin Mesylate Arm B: Dacarbazine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: Eribulin Mesylate Arm B: Dacarbazine
Affected / at Risk (%) Affected / at Risk (%)
Total   76/226 (33.63%)   71/224 (31.70%) 
Blood and lymphatic system disorders     
Neutropenia  1  11/226 (4.87%)  10/224 (4.46%) 
Anaemia  2  5/226 (2.21%)  9/224 (4.02%) 
Leukopenia  2  3/226 (1.33%)  3/224 (1.34%) 
Febrile neutropenia  2  2/226 (0.88%)  2/224 (0.89%) 
Lymphopenia  2  1/226 (0.44%)  0/224 (0.00%) 
Pancytopenia  2  0/226 (0.00%)  3/224 (1.34%) 
Thrombocytopenia  2  0/226 (0.00%)  13/224 (5.80%) 
Cardiac disorders     
Atrial fibrillation  2  1/226 (0.44%)  1/224 (0.45%) 
Pericardial effusion  2  1/226 (0.44%)  0/224 (0.00%) 
Cardiac arrest  2  0/226 (0.00%)  1/224 (0.45%) 
Gastrointestinal disorders     
Abdominal pain  2  4/226 (1.77%)  4/224 (1.79%) 
Intestinal obstruction  2  4/226 (1.77%)  5/224 (2.23%) 
Diarrhoea  2  2/226 (0.88%)  2/224 (0.89%) 
Small intestinal obstruction  2  2/226 (0.88%)  3/224 (1.34%) 
Constipation  2  1/226 (0.44%)  0/224 (0.00%) 
Ileus  2  1/226 (0.44%)  0/224 (0.00%) 
Intestinal ischaemia  2  1/226 (0.44%)  0/224 (0.00%) 
Large intestine perforation  2  1/226 (0.44%)  0/224 (0.00%) 
Oesophagitis  2  1/226 (0.44%)  0/224 (0.00%) 
Retroperitoneal haemorrhage  2  1/226 (0.44%)  0/224 (0.00%) 
Subileus  2  1/226 (0.44%)  0/224 (0.00%) 
Abdominal distension  2  0/226 (0.00%)  1/224 (0.45%) 
Abdominal pain upper  2  0/226 (0.00%)  1/224 (0.45%) 
Diverticulum  2  0/226 (0.00%)  1/224 (0.45%) 
Duodenal fistula  2  0/226 (0.00%)  1/224 (0.45%) 
Gastrointestinal haemorrhage * 1  0/226 (0.00%)  1/224 (0.45%) 
Gastrointestinal ulcer haemorrhage  2  0/226 (0.00%)  1/224 (0.45%) 
Intestinal haemorrhage  2  0/226 (0.00%)  1/224 (0.45%) 
Large intestinal obstruction  2  0/226 (0.00%)  1/224 (0.45%) 
General disorders     
Pyrexia * 1  10/226 (4.42%)  4/224 (1.79%) 
Asthenia  2  3/226 (1.33%)  1/224 (0.45%) 
General physical health deterioration  2  2/226 (0.88%)  1/224 (0.45%) 
Fatigue  2  1/226 (0.44%)  0/224 (0.00%) 
Non-cardiac chest pain  2  0/226 (0.00%)  1/224 (0.45%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  2  2/226 (0.88%)  0/224 (0.00%) 
Biliary dilatation  2  1/226 (0.44%)  0/224 (0.00%) 
Hepatotoxicity  2  1/226 (0.44%)  0/224 (0.00%) 
Cholangitis  2  0/226 (0.00%)  1/224 (0.45%) 
Cholecystitis  2  0/226 (0.00%)  1/224 (0.45%) 
Immune system disorders     
Hypersensitivity  2  1/226 (0.44%)  0/224 (0.00%) 
Drug hypersensitivity  1  0/226 (0.00%)  1/224 (0.45%) 
Infections and infestations     
Urinary tract infection  2  4/226 (1.77%)  1/224 (0.45%) 
Pneumonia  2  3/226 (1.33%)  2/224 (0.89%) 
Lung infection  2  2/226 (0.88%)  0/224 (0.00%) 
Peritonitis bacterial  2  2/226 (0.88%)  0/224 (0.00%) 
Arthritis bacterial  2  1/226 (0.44%)  0/224 (0.00%) 
Bronchopneumonia  2  1/226 (0.44%)  0/224 (0.00%) 
Catheter site infection  2  1/226 (0.44%)  0/224 (0.00%) 
Device related infection  2  1/226 (0.44%)  1/224 (0.45%) 
Lower respiratory tract infection fungal  2  1/226 (0.44%)  0/224 (0.00%) 
Neutropenic sepsis  2  1/226 (0.44%)  0/224 (0.00%) 
Peritonitis  2  1/226 (0.44%)  0/224 (0.00%) 
Pseudomonal bacteraemia  2  1/226 (0.44%)  0/224 (0.00%) 
Pyelonephritis  2  1/226 (0.44%)  0/224 (0.00%) 
Septic shock  2  1/226 (0.44%)  0/224 (0.00%) 
Serratia bacteraemia  2  1/226 (0.44%)  0/224 (0.00%) 
Staphylococcal bacteraemia  2  1/226 (0.44%)  0/224 (0.00%) 
Staphylococcal infection  2  1/226 (0.44%)  0/224 (0.00%) 
Cellulitis  2  0/226 (0.00%)  1/224 (0.45%) 
Erysipelas  2  0/226 (0.00%)  1/224 (0.45%) 
Respiratory tract infection  2  0/226 (0.00%)  1/224 (0.45%) 
Vestibular neuronitis  2  0/226 (0.00%)  1/224 (0.45%) 
Injury, poisoning and procedural complications     
Humerus fracture  2  1/226 (0.44%)  0/224 (0.00%) 
Post procedural haemorrhage  2  1/226 (0.44%)  0/224 (0.00%) 
Radiation pneumonitis  2  1/226 (0.44%)  0/224 (0.00%) 
Wound dehiscence  2  1/226 (0.44%)  0/224 (0.00%) 
Toxicity to various agents  2  0/226 (0.00%)  1/224 (0.45%) 
Investigations     
Alanine aminotransferase increased  2  1/226 (0.44%)  1/224 (0.45%) 
Aspartate aminotransferase increased  2  1/226 (0.44%)  1/224 (0.45%) 
Electrocardiogram QT prolonged  2  1/226 (0.44%)  0/224 (0.00%) 
International normalised ratio increased  2  1/226 (0.44%)  0/224 (0.00%) 
Neutrophil count decreased  2  1/226 (0.44%)  1/224 (0.45%) 
White blood cell count decreased  2  1/226 (0.44%)  0/224 (0.00%) 
Haemoglobin decreased  2  0/226 (0.00%)  2/224 (0.89%) 
Platelet count decreased  2  0/226 (0.00%)  1/224 (0.45%) 
Metabolism and nutrition disorders     
Hypokalaemia  2  1/226 (0.44%)  0/224 (0.00%) 
Hyponatraemia  2  1/226 (0.44%)  0/224 (0.00%) 
Hypophosphataemia  2  1/226 (0.44%)  0/224 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  2  2/226 (0.88%)  0/224 (0.00%) 
Pathological fracture  2  2/226 (0.88%)  1/224 (0.45%) 
Musculoskeletal pain  1  0/226 (0.00%)  1/224 (0.45%) 
Spinal pain  2  0/226 (0.00%)  1/224 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  2  2/226 (0.88%)  0/224 (0.00%) 
Metastases to bone  2  1/226 (0.44%)  0/224 (0.00%) 
Metastases to lung  2  1/226 (0.44%)  1/224 (0.45%) 
Metastases to neck  2  1/226 (0.44%)  0/224 (0.00%) 
Metastatic pain  2  1/226 (0.44%)  0/224 (0.00%) 
Myxoid liposarcoma  2  1/226 (0.44%)  0/224 (0.00%) 
Tumour associated fever  2  1/226 (0.44%)  0/224 (0.00%) 
Tumour haemorrhage  2  1/226 (0.44%)  0/224 (0.00%) 
Intracranial tumour haemorrhage  2  0/226 (0.00%)  1/224 (0.45%) 
Leiomyosarcoma  2  0/226 (0.00%)  1/224 (0.45%) 
Malignant ascites  2  0/226 (0.00%)  1/224 (0.45%) 
Malignant pleural effusion  2  0/226 (0.00%)  2/224 (0.89%) 
Tumour pain  2  0/226 (0.00%)  1/224 (0.45%) 
Nervous system disorders     
Convulsion  2  1/226 (0.44%)  0/224 (0.00%) 
Monoplegia  2  1/226 (0.44%)  0/224 (0.00%) 
Spinal cord compression  2  1/226 (0.44%)  0/224 (0.00%) 
Neuralgia  2  0/226 (0.00%)  1/224 (0.45%) 
Peripheral motor neuropathy  2  0/226 (0.00%)  1/224 (0.45%) 
Renal and urinary disorders     
Renal failure acute  2  1/226 (0.44%)  1/224 (0.45%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  2  4/226 (1.77%)  1/224 (0.45%) 
Respiratory failure  2  4/226 (1.77%)  2/224 (0.89%) 
Dyspnoea  2  2/226 (0.88%)  4/224 (1.79%) 
Acute respiratory failure  2  1/226 (0.44%)  0/224 (0.00%) 
Pneumonia aspiration  2  1/226 (0.44%)  0/224 (0.00%) 
Pneumothorax  2  1/226 (0.44%)  1/224 (0.45%) 
Atelectasis  2  0/226 (0.00%)  1/224 (0.45%) 
Dyspnoea exertional  2  0/226 (0.00%)  1/224 (0.45%) 
Epistaxis  2  0/226 (0.00%)  1/224 (0.45%) 
Hiccups  2  0/226 (0.00%)  1/224 (0.45%) 
Pleural effusion  2  0/226 (0.00%)  2/224 (0.89%) 
Vascular disorders     
Superior vena cava syndrome  2  1/226 (0.44%)  0/224 (0.00%) 
Vena cava thrombosis  2  1/226 (0.44%)  0/224 (0.00%) 
Deep vein thrombosis  2  0/226 (0.00%)  3/224 (1.34%) 
Hypotension  2  0/226 (0.00%)  2/224 (0.89%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 17.1
2
Term from vocabulary, Select
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: Eribulin Mesylate Arm B: Dacarbazine
Affected / at Risk (%) Affected / at Risk (%)
Total   224/226 (99.12%)   218/224 (97.32%) 
Blood and lymphatic system disorders     
Neutropenia  1  95/226 (42.04%)  51/224 (22.77%) 
Anaemia  2  66/226 (29.20%)  68/224 (30.36%) 
Thrombocytopenia  2  13/226 (5.75%)  60/224 (26.79%) 
Leukopenia  2  36/226 (15.93%)  22/224 (9.82%) 
Eye disorders     
Lacrimation increased  2  18/226 (7.96%)  1/224 (0.45%) 
Gastrointestinal disorders     
Nausea  2  91/226 (40.27%)  106/224 (47.32%) 
Constipation  2  70/226 (30.97%)  58/224 (25.89%) 
Abdominal pain  2  42/226 (18.58%)  32/224 (14.29%) 
Vomiting  2  43/226 (19.03%)  50/224 (22.32%) 
Diarrhoea  2  38/226 (16.81%)  35/224 (15.63%) 
Stomatitis  2  31/226 (13.72%)  11/224 (4.91%) 
Abdominal pain upper  2  19/226 (8.41%)  13/224 (5.80%) 
Dyspepsia  2  18/226 (7.96%)  7/224 (3.13%) 
Abdominal distension  2  16/226 (7.08%)  12/224 (5.36%) 
Dry mouth  2  12/226 (5.31%)  4/224 (1.79%) 
General disorders     
Fatigue  2  98/226 (43.36%)  86/224 (38.39%) 
Pyrexia  2  58/226 (25.66%)  28/224 (12.50%) 
Asthenia  2  46/226 (20.35%)  51/224 (22.77%) 
Oedema peripheral  2  27/226 (11.95%)  17/224 (7.59%) 
Infections and infestations     
Urinary tract infection  2  23/226 (10.18%)  11/224 (4.91%) 
Upper respiratory tract infection  2  20/226 (8.85%)  9/224 (4.02%) 
Investigations     
Aspartate aminotransferase increased  2  21/226 (9.29%)  5/224 (2.23%) 
Neutrophil count decreased  2  19/226 (8.41%)  12/224 (5.36%) 
Alanine aminotransferase increased  2  18/226 (7.96%)  8/224 (3.57%) 
White blood cell count decreased  2  16/226 (7.08%)  15/224 (6.70%) 
Electrocardiogram QT prolonged  2  14/226 (6.19%)  11/224 (4.91%) 
Blood lactate dehydrogenase increased  2  12/226 (5.31%)  7/224 (3.13%) 
Platelet count decreased  2  2/226 (0.88%)  17/224 (7.59%) 
Metabolism and nutrition disorders     
Decreased appetite  2  43/226 (19.03%)  43/224 (19.20%) 
Hypokalaemia  2  23/226 (10.18%)  9/224 (4.02%) 
Hyperglycaemia  2  17/226 (7.52%)  6/224 (2.68%) 
Musculoskeletal and connective tissue disorders     
Back pain  2  33/226 (14.60%)  31/224 (13.84%) 
Myalgia  2  23/226 (10.18%)  17/224 (7.59%) 
Pain in extremity  2  20/226 (8.85%)  18/224 (8.04%) 
Arthralgia  2  19/226 (8.41%)  13/224 (5.80%) 
Muscle spasms  2  13/226 (5.75%)  7/224 (3.13%) 
Musculoskeletal pain  2  12/226 (5.31%)  11/224 (4.91%) 
Nervous system disorders     
Peripheral sensory neuropathy * 1  46/226 (20.35%)  8/224 (3.57%) 
Headache * 1  41/226 (18.14%)  21/224 (9.38%) 
Dizziness  2  21/226 (9.29%)  16/224 (7.14%) 
Paraesthesia  1  20/226 (8.85%)  7/224 (3.13%) 
Dysgeusia  2  18/226 (7.96%)  5/224 (2.23%) 
Psychiatric disorders     
Insomnia  2  22/226 (9.73%)  10/224 (4.46%) 
Anxiety * 1  12/226 (5.31%)  14/224 (6.25%) 
Respiratory, thoracic and mediastinal disorders     
Cough  2  39/226 (17.26%)  28/224 (12.50%) 
Dyspnoea * 1  34/226 (15.04%)  33/224 (14.73%) 
Oropharyngeal pain  2  12/226 (5.31%)  5/224 (2.23%) 
Skin and subcutaneous tissue disorders     
Alopecia  2  79/226 (34.96%)  6/224 (2.68%) 
Vascular disorders     
Hypotension  2  13/226 (5.75%)  4/224 (1.79%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 17.1
2
Term from vocabulary, Select
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Eisai Medical Services
Organization: Eisai Inc.
Phone: 1-888-422-4743
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01327885     History of Changes
Other Study ID Numbers: E7389-G000-309
First Submitted: March 31, 2011
First Posted: April 4, 2011
Results First Submitted: January 6, 2017
Results First Posted: February 28, 2017
Last Update Posted: March 12, 2018